<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471831</url>
  </required_header>
  <id_info>
    <org_study_id>CMUL/HREC/06/20/742</org_study_id>
    <nct_id>NCT04471831</nct_id>
  </id_info>
  <brief_title>Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study</brief_title>
  <official_title>Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lagos, Nigeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lagos, Nigeria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces&#xD;
      possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv&#xD;
      with multiple comorbidities.&#xD;
&#xD;
      Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and&#xD;
      sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed&#xD;
      using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic&#xD;
      acid content in the test sample (NA) will be recorded from the virology test results. Their&#xD;
      exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes'&#xD;
      walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements&#xD;
      will be taken at every three days intervals from admission to discharge from&#xD;
      hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to&#xD;
      daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video&#xD;
      platforms will be used for the interactions between the physiotherapists and the&#xD;
      participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and&#xD;
      Nervous System Disorders research group of the University of Lagos, Nigeria will be used for&#xD;
      the E-exercises. The exercise package will be loaded into the phones of the participants at&#xD;
      hospital admission. The Physiotherapists will lead in the exercises through video interaction&#xD;
      will the participants watches the video programme. Their risks for respiratory complications&#xD;
      (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using&#xD;
      independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival&#xD;
      analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval).&#xD;
&#xD;
      Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence&#xD;
      for inclusion of Physiotherapy in the acute management of individuals tested positive for&#xD;
      CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage&#xD;
      to reduce the odds of developing complications expedite discharge and reduce odd of death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Coronavirus disease 2019 (CoViD-19) is a new pathogen that is highly contagious,&#xD;
      can spread quickly, and it is capable of causing enormous health, economic and societal&#xD;
      impacts in any setting (WHO-China joint mission on CoViD-19). Although COVID 19 belongs to&#xD;
      coronavirinae sub-family and coronaviridae family and different from other previous&#xD;
      coronaviruses such as SARS-CoV and influenza Virus with its unique characteristics. Hence,&#xD;
      building scenarios and strategies only on the basis of well-known pathogens risks failing to&#xD;
      exploit all possible measures to slow transmission of the COVID-19 virus, reduce disease and&#xD;
      save lives.&#xD;
&#xD;
      The COVID-19 virus is unique among human coronaviruses in its combination of high&#xD;
      transmissibility, substantial fatal outcomes in some high-risk groups, and ability to cause&#xD;
      huge societal and economic disruption. The current CoViD-19 pandemic arises from Severe Acute&#xD;
      Respiratory Syndrome Voronavirus 2 (SARS CoV-2) which was first detected as pneumonia of&#xD;
      unknown cause in Wuhan, China in December, 2019. It was declared as public health emergency&#xD;
      of international concern in January, 2020 and global pandemic in February of the same year.&#xD;
      Therefore, with the novel nature, and the continuously evolving understanding, of this&#xD;
      coronavirus demands a tremendous agility in the capacity to rapidly adapt and change&#xD;
      readiness and response planning both for containment and for treatment of the disease and its&#xD;
      emerging sequels.&#xD;
&#xD;
      Before the advent of CoViD-19, different types of coronavirus known in human history include&#xD;
      the alpha coronaviruses HCoV-229E and HCoV-NL63; the beta coronaviruses HCoV-OC43 and&#xD;
      HCoV-HKU1; SARS-CoV, which causes severe acute respiratory syndrome (SARS); MERS-CoV, which&#xD;
      causes Middle East respiratory syndrome (MERS). The definitive diagnosis of CoViD-19 is made&#xD;
      by analysing respiratory samples (collected by aspiration of the airways or sputum induction)&#xD;
      through laboratory tests to identify the virus involved using Real-Time Polymerase Chain&#xD;
      Reaction (RT-PCR) techniques.&#xD;
&#xD;
      Although the American and Europe are mostly affected with Africa being the least affected,&#xD;
      almost all the African countries have had their fair share of the pandemic both in incidence&#xD;
      and in fatality. Although the first fatality was recorded in China, the fatality is now&#xD;
      global. There is no gender variation in the global epidemiology of CoViD-19 but the males are&#xD;
      experiencing higher fatality rate when controlled for age and the presence of comorbid health&#xD;
      problem. However, in Nigeria, the mortality rate is 3.1% with male preponderance (2.2:1 male&#xD;
      to female ratio) and affects more people between 31 years and 40 years.&#xD;
&#xD;
      Between 2 days to 14 days post-exposure, individuals with CoViD-19 can have symptoms ranging&#xD;
      from mild to severe including but not limited to fever, cough, difficulty in&#xD;
      breathing/shortness of breath, sore throat, muscle pain, chills, new loss of taste or smell,&#xD;
      nausea, vomiting and diarrhea. Although the disease is fast spreading across the globe, yet&#xD;
      there is no known standard cure for it neither is vaccine available against the new virus.&#xD;
      However, as the disease manifest its clinical features, various case management/treatment&#xD;
      guidelines are being developed and updated periodically by all national and international&#xD;
      health organisations and the WHO.&#xD;
&#xD;
      Because CoViD-19 is a novel pathogen, the existence of innate immunity in human being cannot&#xD;
      be ascertained. Based on the epidemiologic characteristics observed in China, although there&#xD;
      may be risk factors increasing susceptibility to infection, everyone is assumed to be&#xD;
      susceptible. Since the start of the COVID-19 outbreak, there have been extensive attempts to&#xD;
      better understand the virus and the disease globally. However, key knowledge gaps in the&#xD;
      source of infection, pathogenesis and virulence of the virus, transmissibility, risk factors&#xD;
      for infection and disease progression, surveillance, diagnostics, clinical management of&#xD;
      severe and critically ill patients, and the effectiveness of prevention and control measures&#xD;
      remain. The remarkable speed with which health experts isolated the causative virus,&#xD;
      established diagnostic tools, and determined key transmission parameters, such as the route&#xD;
      of spread and incubation period, provided the vital evidence for gaining invaluable time for&#xD;
      the response.&#xD;
&#xD;
      Although the radiological evidence (Lima, 2020) and laboratory tests are been used as&#xD;
      complimentary approaches to objectify the diagnosis and progression of CoViD-19, the&#xD;
      molecular test of choice for the etiologic diagnosis of SARS-CoV-2 infection is the real&#xD;
      -time reverse transcription-polymerase chain reaction (RT-PCR) test method similar to that&#xD;
      developed for the diagnosis of SARS-CoV. Within 5 to 6 days of the onset of symptoms,&#xD;
      patients with COVID-19 infections have demonstrated high viral loads in their upper and lower&#xD;
      respiratory tract. A nasopharyngeal swab and/or an oropharyngeal swab are often recommended&#xD;
      for screening or diagnosis of early infection. In RT-PCR assay a positive reaction is&#xD;
      detected by accumulation of a fluorescent signal and quantified by the cycle threshold (CT)&#xD;
      values. The CT is the number of cycles required for the fluorescent signal to cross the&#xD;
      threshold (exceeds background level). Cycle threshold levels are inversely proportional to&#xD;
      the amount of target nucleic acid in the sample (the lower the CT level the greater the&#xD;
      amount of target nucleic acid in the sample). Wisconsin Veterinary and Diagnostic Laboratory&#xD;
      (WVDL) real time assays undergo 40 cycles of amplification. Cycle thresholds (CTs) less than&#xD;
      29 are strong positive reactions indicative of abundant target nucleic acid in the sample,&#xD;
      CTs of between 30 and 37 are positive reactions indicative of moderate amounts of target&#xD;
      nucleic acid while CTs of between 38 and 40 are weak reactions indicative of minimal amounts&#xD;
      of target nucleic acid which could represent an infection state or environmental&#xD;
      contamination.&#xD;
&#xD;
      Previous studies had opined that increased age, pre-existing concurrent cardiovascular or&#xD;
      cerebrovascular diseases, the presence of secondary infection and elevated inflammatory&#xD;
      indicators in the blood, CD3+CD8+ T-cells ≤75 cells·μL-1 and cardiac troponin I ≥0.05 ng·mL-1&#xD;
      are predictors of increase in risk of mortality from CoViD-19. With stroke being a leading&#xD;
      cause of death and a major cause of disability worldwide (Bay, 2001), a stroke patient with&#xD;
      CoVid-19 may be said to be in pathway to death. Individuals who have experienced stroke are&#xD;
      faced with a multitude of challenges to restore their quality of life within the limitation&#xD;
      of residual impairment. A stroke patient with clotting disorder is in continuous dynamics of&#xD;
      working against the development of deep vein thrombosis. It is even a great dilemma when a&#xD;
      stroke survivor with clotting disorders has chronic respiratory problem. Much&#xD;
      multi-disciplinary approaches and expertise will be needed for the recovery and&#xD;
      rehabilitation of the patient. Hence, a CoViD-19 patient who ordinarily is susceptible to&#xD;
      developing respiratory complications usually require experts' management especially when the&#xD;
      individual has the high odd ratio of death through the presence of comorbid health such as&#xD;
      restrictive respiratory disorders, diabetes, hypertension and other comorbidities. A stroke&#xD;
      patient with haematological disorders especially of clotting factor disorders. If personal&#xD;
      protective equipment (PPEs) are provided, a physiotherapist should be involved in the acute&#xD;
      care of individuals with CoViD-19 especially when clinical manifestations of CoViD-19&#xD;
      indicated how Physiotherapy can be of great help to CoViD-19 patients. There are also&#xD;
      appropriate Physiotherapy management guidelines for the management of such a patient.&#xD;
&#xD;
      Despite the success of the involvement of physiotherapy in the management of individuals&#xD;
      admitted for SARS-CoV. which has similar clinical features as the novel SARS-CoV2 (CoViD-19),&#xD;
      Physiotherapy are rarely involved in its management especially in low resource countries. The&#xD;
      major targeted aspects for Physiotherapy in critically ill patients include deconditioning,&#xD;
      muscle weakness, joint stiffness, retained airway secretions, atelectasis and avoidance of&#xD;
      intubation and weaning failure. Physiotherapy is helpful in managing patients with severe&#xD;
      acute respiratory distress syndrome (SARS). Physiotherapy focus is to increase mobility,&#xD;
      enhance oxygenation and reduce the risk of ventilator-associated pneumonia. In managing SARS&#xD;
      or Acute Respiratory Disorders' patients, Physiotherapy employed various treatment techniques&#xD;
      such as the use of various chest Physiotherapy procedures, positioning/mobilization,&#xD;
      breathing exercises techniques, coughing techniques, spirometry and Massage/manual techniques&#xD;
      among others. Apart from the fact that physiotherapists have the expertise in management of&#xD;
      CoViD-19 patient, a patient undergoing physiotherapy can also be infected with CoViD-19 as no&#xD;
      one is immune. In order to prevent secondary complication of both the clinical manifestations&#xD;
      of CoViD-19 in one hand and that of their other health problems, patients with CoViD-19&#xD;
      should be treated by physiotherapists from the acute case and even in the intensive care&#xD;
      units/centres. Hence, this study intends to explore success of involvement of physiotherapy&#xD;
      in the acute management of stroke survivors with multiple comorbidities who are diagnosed of&#xD;
      CoViD-19 in reducing odds of developing complications, reduce the odd of death and expedite&#xD;
      discharge.&#xD;
&#xD;
      Rationale/ justification of study Because the novel CoViD-19 can affect anyone including&#xD;
      stroke patients who are receiving physiotherapy, it is highly imperative for a programme that&#xD;
      will incorporate physiotherapy into their treatment to both prevent the possibility of&#xD;
      developing complications as well as death during the isolation treatment. It will also&#xD;
      address their needs for stroke recovery thereby preventing disability and dependency in&#xD;
      activity of daily living due to stroke which will linger during the isolation treatment.&#xD;
&#xD;
      Previous studies had opined that increased age, pre-existing concurrent cardiovascular or&#xD;
      cerebrovascular diseases, the presence of secondary infection and elevated inflammatory&#xD;
      indicators in the blood, CD3+CD8+ T-cells ≤75 cells·μL-1 and cardiac troponin I ≥0.05 ng·mL-1&#xD;
      are predictors of increase in risk of mortality from CoViD-19. Since these factors are either&#xD;
      predisposing factors to stroke or precipitate mortality in stroke patients, a stroke&#xD;
      patient/survivor tested positive for CoViD-19 is in serious dilemma for the likelihood of&#xD;
      developing complications or dying during CoViD-19 isolation treatment. With stroke being a&#xD;
      leading cause of death and a major cause of disability worldwide, a stroke patient with&#xD;
      CoVid-19 may be said to be in pathway to death. Individuals who have experienced stroke are&#xD;
      faced with a multitude of challenges to restore their quality of life within the limitation&#xD;
      of residual impairment. A stroke patient with clotting disorder is in continuous dynamics of&#xD;
      working against the development of deep vein thrombosis. It is even a great dilemma when a&#xD;
      stroke survivor with clotting disorders has chronic respiratory problem. Much&#xD;
      multi-disciplinary approaches and expertise will be needed for the recovery and&#xD;
      rehabilitation of the patient. Hence, a CoViD-19 patient who ordinarily is susceptible to&#xD;
      developing respiratory complications usually require experts' management especially when the&#xD;
      individual has the high odd ratio of death through the presence of comorbid health such as&#xD;
      restrictive respiratory disorders, diabetes, hypertension and other comorbidities. A stroke&#xD;
      patient with haematological disorders especially of clotting factor disorders. If personal&#xD;
      protective equipment (PPEs) are provided, a physiotherapist should be involved in the acute&#xD;
      care of individuals with CoViD-19 especially when clinical manifestations of CoViD-19&#xD;
      indicated how Physiotherapy can be of great help to CoViD-19 patients. There are also&#xD;
      appropriate Physiotherapy management guidelines for the management of such a patient .&#xD;
&#xD;
      Despite the success of the involvement of physiotherapy in the management of individuals&#xD;
      admitted for SARS-CoV. which has similar clinical features as the novel SARS-CoV2 (CoViD-19),&#xD;
      and the fact that some individuals undergoing physiotherapy do contract CoViD-19,&#xD;
      Physiotherapy are rarely involved in its management especially in low resource countries. The&#xD;
      major targeted aspects for Physiotherapy in critically ill patients include deconditioning,&#xD;
      muscle weakness, joint stiffness, retained airway secretions, atelectasis and avoidance of&#xD;
      intubation and weaning failure. Physiotherapy is helpful in managing patients with severe&#xD;
      acute respiratory distress syndrome (SARS). Physiotherapy focus is to increase mobility,&#xD;
      enhance oxygenation and reduce the risk of ventilator-associated pneumonia. In managing SARS&#xD;
      or Acute Respiratory Disorders' patients, Physiotherapy employed various treatment techniques&#xD;
      such as the use of various chest Physiotherapy procedures, positioning/mobilization,&#xD;
      breathing exercises techniques, coughing techniques, spirometry and Massage/manual techniques&#xD;
      among others. Apart from the fact that physiotherapists have the expertise in management of&#xD;
      CoViD-19 patient, a patient undergoing physiotherapy can also be infected with CoViD-19 as no&#xD;
      one is immune. In order to prevent secondary complication of both the clinical manifestations&#xD;
      of CoViD-19 in one hand and that of their other health problems, patients with CoViD-19&#xD;
      should be treated by physiotherapists from the acute case and even in the intensive care&#xD;
      units/centres. Hence, this study intends to explore success of involvement of physiotherapy&#xD;
      in the acute management of stroke survivors with multiple comorbidities who were diagnosed of&#xD;
      CoViD-19 in reducing odds of developing complications and death.&#xD;
&#xD;
      Study objectives&#xD;
&#xD;
        1. To explore effect of physiotherapy on of viral load as measured by Cycle Threshold (CT)&#xD;
           and amount of Nucleic Acid (NA) in the sample of stroke survivors positive for CoViD-19&#xD;
           and their sex age and comorbid heath-status non-stroke individuals positive for&#xD;
           CoViD-19.&#xD;
&#xD;
        2. To explore effect of physiotherapy on development of respiratory complications in the&#xD;
           management of stroke survivors positive for CoViD-19 and their sex age and comorbid&#xD;
           heath-status non-stroke individuals positive for CoViD-19.&#xD;
&#xD;
        3. To explore effect of physiotherapy on use of ventilator in management of stroke&#xD;
           survivors positive for CoViD-19 and their sex age and comorbid heath-status non-stroke&#xD;
           individuals positive for CoViD-19.&#xD;
&#xD;
        4. To explore effect of physiotherapy on death in management of stroke survivors positive&#xD;
           for CoViD-19 and their sex age and comorbid heath-status non-stroke individuals positive&#xD;
           for CoViD-19.&#xD;
&#xD;
        5. To explore effect of physiotherapy on discharge in management of stroke survivors&#xD;
           positive for CoViD-19 and their sex age and comorbid heath-status non-stroke individuals&#xD;
           positive for CoViD-19.&#xD;
&#xD;
        6. To explore effect of physiotherapy on quality of life of stroke survivors positive for&#xD;
           CoViD-19 and their sex age and comorbid heath-status non-stroke individuals positive for&#xD;
           CoViD-19.&#xD;
&#xD;
        7. To explore the effect of Physiotherapy on exercise endurance of stroke survivors&#xD;
           positive for CoViD-19.&#xD;
&#xD;
        8. To explore the effect of Physiotherapy on exercise capacity of stroke survivors positive&#xD;
           for CoViD-19.&#xD;
&#xD;
      Hypotheses&#xD;
&#xD;
        1. There will be no significant difference in the viral-load as measured by CT and NA in&#xD;
           stroke survivors with CoViD-19 who received physiotherapy and their age, sex and&#xD;
           co-morbid heath status-matched non-stroke individuals with CoViD-19 who did not receive&#xD;
           physiotherapy during isolation treatment.&#xD;
&#xD;
        2. There will be no significant difference in the development of respiratory complication&#xD;
           in stroke survivors with CoViD-19 who received physiotherapy and their age, sex and&#xD;
           co-morbid heath status-matched non-stroke individuals with CoViD-19 who did not receive&#xD;
           physiotherapy during isolation treatment.&#xD;
&#xD;
        3. There will be no significant difference in the use ventilator in stroke survivors with&#xD;
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath&#xD;
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy&#xD;
           during isolation treatment.&#xD;
&#xD;
        4. There will be no significant difference in the death recorded in stroke survivors with&#xD;
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath&#xD;
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy&#xD;
           during isolation treatment.&#xD;
&#xD;
        5. There will be no significant difference in the rate of discharge in stroke survivors&#xD;
           with CoViD-19 who received physiotherapy and their age, sex and co-morbid heath&#xD;
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy&#xD;
           during isolation treatment.&#xD;
&#xD;
        6. There will be no significant difference in the quality of life in stroke survivors with&#xD;
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath&#xD;
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy&#xD;
           during isolation treatment.&#xD;
&#xD;
        7. Physiotherapy will not have significant effect on the exercise endurance of stroke&#xD;
           survivors positive for CoViD-19.&#xD;
&#xD;
        8. Physiotherapy will not have significant effect on the exercise capacity of stroke&#xD;
           survivors positive for CoViD-19.&#xD;
&#xD;
      Data Analysis Data will be summarized using frequency, percentage, mean and standard&#xD;
      deviation. Both groups will be analysed for risk for respiratory complications (RC),&#xD;
      likelihood of ventilation (LV) and risk of death (RD) at hospital-isolation admission. The&#xD;
      two groups and difference dichotomies will be compared using independent t-test comparing the&#xD;
      Cycle Threshold Values and the amount of Nucleic Acid in the sample. Analysis of Co-Variance&#xD;
      will be used to compare the Cycle Threshold, Nucleic Acid, Exercise endurance and exercise&#xD;
      capacity across the test periods in the stroke survivors while multivariate regression&#xD;
      analysis will be used to predict odds of complication and survival analysis will be used to&#xD;
      predict death in both groups. Their quality of life will be compared using MannWithney U test&#xD;
      while Friedman Analysis of Variance will be used to compare the quality of life within the&#xD;
      group across the test periods (p&lt;0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 13, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This clinical controlled study will involve a minimum of 30 stroke survivors who is positive for coronavirus (CoViD-19) admitted into different isolation centres in Nigeria</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The identification and selection of participants will be done by none of investigators. Allocation into group will also be done by none of the investigators. Outcome assessment will be done by none of the investigators. Participants will not be privy to another group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cycle Threshold (CT) values as recorded from the series of the qRT-PCR</measure>
    <time_frame>From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented</time_frame>
    <description>The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR</measure>
    <time_frame>From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented</time_frame>
    <description>This is the inverse of the Cycle Threshold. It does not have unit of measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life perception</measure>
    <time_frame>From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented</time_frame>
    <description>Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented</time_frame>
    <description>The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise endurance</measure>
    <time_frame>From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented</time_frame>
    <description>The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke survivors with COVID19</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The active intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-stroke individuals with COVID19</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching for age, sex and co-morbid status with the stroke survivors</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation exercise protocol</intervention_name>
    <description>The exercise package will then be sent to them after securing video contact with the prospective participant. Only participants with smart phone that can receive the video package will be selected for this study.&#xD;
Physiotherapy-Patients' Engagements At every morning after their prescribed drugs might have been served in the ward, the physiotherapist will call the participant for the exercises. The patient will be connected to the physiotherapist who is in his clinic (not in the isolation ward with the patients) through a WhatsApp or zoom video call. The physiotherapist will control the rhythm and pace of the exercises through the video interactions.</description>
    <arm_group_label>Non-stroke individuals with COVID19</arm_group_label>
    <arm_group_label>Stroke survivors with COVID19</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke survivors with COVID19&#xD;
&#xD;
          -  Non-stroke individuals with COVID19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke survivors still in inpatient hospital care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caleb AO Gbiri, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lagos, Nigeria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caleb AO Gbiri, PhD</last_name>
    <phone>+2347084567759</phone>
    <email>cgbiri@unilag.edu.ng</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jibrin S Usman, MSc</last_name>
    <phone>+2348069766797</phone>
    <email>jibrilphysio@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lagos, Nigeria</investigator_affiliation>
    <investigator_full_name>Caleb Ademola Omuwa Gbiri</investigator_full_name>
    <investigator_title>Senior Lecturer and Neurophysiotherapist</investigator_title>
  </responsible_party>
  <keyword>COVID19</keyword>
  <keyword>Stroke patient/survivors</keyword>
  <keyword>Viral load</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Exercise capacity</keyword>
  <keyword>Exercise endurance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Share with the participants&#xD;
=Share through public lecture&#xD;
Share through publication in peer review journals</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>For data merging and comparison</ipd_time_frame>
    <ipd_access_criteria>on demand</ipd_access_criteria>
    <ipd_url>http://www.snersdfoundation.com.ng</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471831
org study id: CMUL/HREC/06/20/742
nct id: NCT04471831
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces
      possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv
      with multiple comorbidities.

      Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and
      sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed
      using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic
      acid content in the test sample (NA) will be recorded from the virology test results. Their
      exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes'
      walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements
      will be taken at every three days intervals from admission to discharge from
      hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to
      daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video
      platforms will be used for the interactions between the physiotherapists and the
      participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and
      Nervous System Disorders research group of the University of Lagos, Nigeria will be used for
      the E-exercises. The exercise package will be loaded into the phones of the participants at
      hospital admission. The Physiotherapists will lead in the exercises through video interaction
      will the participants watches the video programme. Their risks for respiratory complications
      (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using
      independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival
      analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval).

      Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence
      for inclusion of Physiotherapy in the acute management of individuals tested positive for
      CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage
      to reduce the odds of developing complications expedite discharge and reduce odd of death.
Introduction Coronavirus disease 2019 (CoViD-19) is a new pathogen that is highly contagious,
      can spread quickly, and it is capable of causing enormous health, economic and societal
      impacts in any setting (WHO-China joint mission on CoViD-19). Although COVID 19 belongs to
      coronavirinae sub-family and coronaviridae family and different from other previous
      coronaviruses such as SARS-CoV and influenza Virus with its unique characteristics. Hence,
      building scenarios and strategies only on the basis of well-known pathogens risks failing to
      exploit all possible measures to slow transmission of the COVID-19 virus, reduce disease and
      save lives.

      The COVID-19 virus is unique among human coronaviruses in its combination of high
      transmissibility, substantial fatal outcomes in some high-risk groups, and ability to cause
      huge societal and economic disruption. The current CoViD-19 pandemic arises from Severe Acute
      Respiratory Syndrome Voronavirus 2 (SARS CoV-2) which was first detected as pneumonia of
      unknown cause in Wuhan, China in December, 2019. It was declared as public health emergency
      of international concern in January, 2020 and global pandemic in February of the same year.
      Therefore, with the novel nature, and the continuously evolving understanding, of this
      coronavirus demands a tremendous agility in the capacity to rapidly adapt and change
      readiness and response planning both for containment and for treatment of the disease and its
      emerging sequels.

      Before the advent of CoViD-19, different types of coronavirus known in human history include
      the alpha coronaviruses HCoV-229E and HCoV-NL63; the beta coronaviruses HCoV-OC43 and
      HCoV-HKU1; SARS-CoV, which causes severe acute respiratory syndrome (SARS); MERS-CoV, which
      causes Middle East respiratory syndrome (MERS). The definitive diagnosis of CoViD-19 is made
      by analysing respiratory samples (collected by aspiration of the airways or sputum induction)
      through laboratory tests to identify the virus involved using Real-Time Polymerase Chain
      Reaction (RT-PCR) techniques.

      Although the American and Europe are mostly affected with Africa being the least affected,
      almost all the African countries have had their fair share of the pandemic both in incidence
      and in fatality. Although the first fatality was recorded in China, the fatality is now
      global. There is no gender variation in the global epidemiology of CoViD-19 but the males are
      experiencing higher fatality rate when controlled for age and the presence of comorbid health
      problem. However, in Nigeria, the mortality rate is 3.1% with male preponderance (2.2:1 male
      to female ratio) and affects more people between 31 years and 40 years.

      Between 2 days to 14 days post-exposure, individuals with CoViD-19 can have symptoms ranging
      from mild to severe including but not limited to fever, cough, difficulty in
      breathing/shortness of breath, sore throat, muscle pain, chills, new loss of taste or smell,
      nausea, vomiting and diarrhea. Although the disease is fast spreading across the globe, yet
      there is no known standard cure for it neither is vaccine available against the new virus.
      However, as the disease manifest its clinical features, various case management/treatment
      guidelines are being developed and updated periodically by all national and international
      health organisations and the WHO.

      Because CoViD-19 is a novel pathogen, the existence of innate immunity in human being cannot
      be ascertained. Based on the epidemiologic characteristics observed in China, although there
      may be risk factors increasing susceptibility to infection, everyone is assumed to be
      susceptible. Since the start of the COVID-19 outbreak, there have been extensive attempts to
      better understand the virus and the disease globally. However, key knowledge gaps in the
      source of infection, pathogenesis and virulence of the virus, transmissibility, risk factors
      for infection and disease progression, surveillance, diagnostics, clinical management of
      severe and critically ill patients, and the effectiveness of prevention and control measures
      remain. The remarkable speed with which health experts isolated the causative virus,
      established diagnostic tools, and determined key transmission parameters, such as the route
      of spread and incubation period, provided the vital evidence for gaining invaluable time for
      the response.

      Although the radiological evidence (Lima, 2020) and laboratory tests are been used as
      complimentary approaches to objectify the diagnosis and progression of CoViD-19, the
      molecular test of choice for the etiologic diagnosis of SARS-CoV-2 infection is the real
      -time reverse transcription-polymerase chain reaction (RT-PCR) test method similar to that
      developed for the diagnosis of SARS-CoV. Within 5 to 6 days of the onset of symptoms,
      patients with COVID-19 infections have demonstrated high viral loads in their upper and lower
      respiratory tract. A nasopharyngeal swab and/or an oropharyngeal swab are often recommended
      for screening or diagnosis of early infection. In RT-PCR assay a positive reaction is
      detected by accumulation of a fluorescent signal and quantified by the cycle threshold (CT)
      values. The CT is the number of cycles required for the fluorescent signal to cross the
      threshold (exceeds background level). Cycle threshold levels are inversely proportional to
      the amount of target nucleic acid in the sample (the lower the CT level the greater the
      amount of target nucleic acid in the sample). Wisconsin Veterinary and Diagnostic Laboratory
      (WVDL) real time assays undergo 40 cycles of amplification. Cycle thresholds (CTs) less than
      29 are strong positive reactions indicative of abundant target nucleic acid in the sample,
      CTs of between 30 and 37 are positive reactions indicative of moderate amounts of target
      nucleic acid while CTs of between 38 and 40 are weak reactions indicative of minimal amounts
      of target nucleic acid which could represent an infection state or environmental
      contamination.

      Previous studies had opined that increased age, pre-existing concurrent cardiovascular or
      cerebrovascular diseases, the presence of secondary infection and elevated inflammatory
      indicators in the blood, CD3+CD8+ T-cells ≤75 cells·μL-1 and cardiac troponin I ≥0.05 ng·mL-1
      are predictors of increase in risk of mortality from CoViD-19. With stroke being a leading
      cause of death and a major cause of disability worldwide (Bay, 2001), a stroke patient with
      CoVid-19 may be said to be in pathway to death. Individuals who have experienced stroke are
      faced with a multitude of challenges to restore their quality of life within the limitation
      of residual impairment. A stroke patient with clotting disorder is in continuous dynamics of
      working against the development of deep vein thrombosis. It is even a great dilemma when a
      stroke survivor with clotting disorders has chronic respiratory problem. Much
      multi-disciplinary approaches and expertise will be needed for the recovery and
      rehabilitation of the patient. Hence, a CoViD-19 patient who ordinarily is susceptible to
      developing respiratory complications usually require experts' management especially when the
      individual has the high odd ratio of death through the presence of comorbid health such as
      restrictive respiratory disorders, diabetes, hypertension and other comorbidities. A stroke
      patient with haematological disorders especially of clotting factor disorders. If personal
      protective equipment (PPEs) are provided, a physiotherapist should be involved in the acute
      care of individuals with CoViD-19 especially when clinical manifestations of CoViD-19
      indicated how Physiotherapy can be of great help to CoViD-19 patients. There are also
      appropriate Physiotherapy management guidelines for the management of such a patient.

      Despite the success of the involvement of physiotherapy in the management of individuals
      admitted for SARS-CoV. which has similar clinical features as the novel SARS-CoV2 (CoViD-19),
      Physiotherapy are rarely involved in its management especially in low resource countries. The
      major targeted aspects for Physiotherapy in critically ill patients include deconditioning,
      muscle weakness, joint stiffness, retained airway secretions, atelectasis and avoidance of
      intubation and weaning failure. Physiotherapy is helpful in managing patients with severe
      acute respiratory distress syndrome (SARS). Physiotherapy focus is to increase mobility,
      enhance oxygenation and reduce the risk of ventilator-associated pneumonia. In managing SARS
      or Acute Respiratory Disorders' patients, Physiotherapy employed various treatment techniques
      such as the use of various chest Physiotherapy procedures, positioning/mobilization,
      breathing exercises techniques, coughing techniques, spirometry and Massage/manual techniques
      among others. Apart from the fact that physiotherapists have the expertise in management of
      CoViD-19 patient, a patient undergoing physiotherapy can also be infected with CoViD-19 as no
      one is immune. In order to prevent secondary complication of both the clinical manifestations
      of CoViD-19 in one hand and that of their other health problems, patients with CoViD-19
      should be treated by physiotherapists from the acute case and even in the intensive care
      units/centres. Hence, this study intends to explore success of involvement of physiotherapy
      in the acute management of stroke survivors with multiple comorbidities who are diagnosed of
      CoViD-19 in reducing odds of developing complications, reduce the odd of death and expedite
      discharge.

      Rationale/ justification of study Because the novel CoViD-19 can affect anyone including
      stroke patients who are receiving physiotherapy, it is highly imperative for a programme that
      will incorporate physiotherapy into their treatment to both prevent the possibility of
      developing complications as well as death during the isolation treatment. It will also
      address their needs for stroke recovery thereby preventing disability and dependency in
      activity of daily living due to stroke which will linger during the isolation treatment.

      Previous studies had opined that increased age, pre-existing concurrent cardiovascular or
      cerebrovascular diseases, the presence of secondary infection and elevated inflammatory
      indicators in the blood, CD3+CD8+ T-cells ≤75 cells·μL-1 and cardiac troponin I ≥0.05 ng·mL-1
      are predictors of increase in risk of mortality from CoViD-19. Since these factors are either
      predisposing factors to stroke or precipitate mortality in stroke patients, a stroke
      patient/survivor tested positive for CoViD-19 is in serious dilemma for the likelihood of
      developing complications or dying during CoViD-19 isolation treatment. With stroke being a
      leading cause of death and a major cause of disability worldwide, a stroke patient with
      CoVid-19 may be said to be in pathway to death. Individuals who have experienced stroke are
      faced with a multitude of challenges to restore their quality of life within the limitation
      of residual impairment. A stroke patient with clotting disorder is in continuous dynamics of
      working against the development of deep vein thrombosis. It is even a great dilemma when a
      stroke survivor with clotting disorders has chronic respiratory problem. Much
      multi-disciplinary approaches and expertise will be needed for the recovery and
      rehabilitation of the patient. Hence, a CoViD-19 patient who ordinarily is susceptible to
      developing respiratory complications usually require experts' management especially when the
      individual has the high odd ratio of death through the presence of comorbid health such as
      restrictive respiratory disorders, diabetes, hypertension and other comorbidities. A stroke
      patient with haematological disorders especially of clotting factor disorders. If personal
      protective equipment (PPEs) are provided, a physiotherapist should be involved in the acute
      care of individuals with CoViD-19 especially when clinical manifestations of CoViD-19
      indicated how Physiotherapy can be of great help to CoViD-19 patients. There are also
      appropriate Physiotherapy management guidelines for the management of such a patient .

      Despite the success of the involvement of physiotherapy in the management of individuals
      admitted for SARS-CoV. which has similar clinical features as the novel SARS-CoV2 (CoViD-19),
      and the fact that some individuals undergoing physiotherapy do contract CoViD-19,
      Physiotherapy are rarely involved in its management especially in low resource countries. The
      major targeted aspects for Physiotherapy in critically ill patients include deconditioning,
      muscle weakness, joint stiffness, retained airway secretions, atelectasis and avoidance of
      intubation and weaning failure. Physiotherapy is helpful in managing patients with severe
      acute respiratory distress syndrome (SARS). Physiotherapy focus is to increase mobility,
      enhance oxygenation and reduce the risk of ventilator-associated pneumonia. In managing SARS
      or Acute Respiratory Disorders' patients, Physiotherapy employed various treatment techniques
      such as the use of various chest Physiotherapy procedures, positioning/mobilization,
      breathing exercises techniques, coughing techniques, spirometry and Massage/manual techniques
      among others. Apart from the fact that physiotherapists have the expertise in management of
      CoViD-19 patient, a patient undergoing physiotherapy can also be infected with CoViD-19 as no
      one is immune. In order to prevent secondary complication of both the clinical manifestations
      of CoViD-19 in one hand and that of their other health problems, patients with CoViD-19
      should be treated by physiotherapists from the acute case and even in the intensive care
      units/centres. Hence, this study intends to explore success of involvement of physiotherapy
      in the acute management of stroke survivors with multiple comorbidities who were diagnosed of
      CoViD-19 in reducing odds of developing complications and death.

      Study objectives

        1. To explore effect of physiotherapy on of viral load as measured by Cycle Threshold (CT)
           and amount of Nucleic Acid (NA) in the sample of stroke survivors positive for CoViD-19
           and their sex age and comorbid heath-status non-stroke individuals positive for
           CoViD-19.

        2. To explore effect of physiotherapy on development of respiratory complications in the
           management of stroke survivors positive for CoViD-19 and their sex age and comorbid
           heath-status non-stroke individuals positive for CoViD-19.

        3. To explore effect of physiotherapy on use of ventilator in management of stroke
           survivors positive for CoViD-19 and their sex age and comorbid heath-status non-stroke
           individuals positive for CoViD-19.

        4. To explore effect of physiotherapy on death in management of stroke survivors positive
           for CoViD-19 and their sex age and comorbid heath-status non-stroke individuals positive
           for CoViD-19.

        5. To explore effect of physiotherapy on discharge in management of stroke survivors
           positive for CoViD-19 and their sex age and comorbid heath-status non-stroke individuals
           positive for CoViD-19.

        6. To explore effect of physiotherapy on quality of life of stroke survivors positive for
           CoViD-19 and their sex age and comorbid heath-status non-stroke individuals positive for
           CoViD-19.

        7. To explore the effect of Physiotherapy on exercise endurance of stroke survivors
           positive for CoViD-19.

        8. To explore the effect of Physiotherapy on exercise capacity of stroke survivors positive
           for CoViD-19.

      Hypotheses

        1. There will be no significant difference in the viral-load as measured by CT and NA in
           stroke survivors with CoViD-19 who received physiotherapy and their age, sex and
           co-morbid heath status-matched non-stroke individuals with CoViD-19 who did not receive
           physiotherapy during isolation treatment.

        2. There will be no significant difference in the development of respiratory complication
           in stroke survivors with CoViD-19 who received physiotherapy and their age, sex and
           co-morbid heath status-matched non-stroke individuals with CoViD-19 who did not receive
           physiotherapy during isolation treatment.

        3. There will be no significant difference in the use ventilator in stroke survivors with
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy
           during isolation treatment.

        4. There will be no significant difference in the death recorded in stroke survivors with
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy
           during isolation treatment.

        5. There will be no significant difference in the rate of discharge in stroke survivors
           with CoViD-19 who received physiotherapy and their age, sex and co-morbid heath
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy
           during isolation treatment.

        6. There will be no significant difference in the quality of life in stroke survivors with
           CoViD-19 who received physiotherapy and their age, sex and co-morbid heath
           status-matched non-stroke individuals with CoViD-19 who did not receive physiotherapy
           during isolation treatment.

        7. Physiotherapy will not have significant effect on the exercise endurance of stroke
           survivors positive for CoViD-19.

        8. Physiotherapy will not have significant effect on the exercise capacity of stroke
           survivors positive for CoViD-19.

      Data Analysis Data will be summarized using frequency, percentage, mean and standard
      deviation. Both groups will be analysed for risk for respiratory complications (RC),
      likelihood of ventilation (LV) and risk of death (RD) at hospital-isolation admission. The
      two groups and difference dichotomies will be compared using independent t-test comparing the
      Cycle Threshold Values and the amount of Nucleic Acid in the sample. Analysis of Co-Variance
      will be used to compare the Cycle Threshold, Nucleic Acid, Exercise endurance and exercise
      capacity across the test periods in the stroke survivors while multivariate regression
      analysis will be used to predict odds of complication and survival analysis will be used to
      predict death in both groups. Their quality of life will be compared using MannWithney U test
      while Friedman Analysis of Variance will be used to compare the quality of life within the
      group across the test periods (p<0.05).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This clinical controlled study will involve a minimum of 30 stroke survivors who is positive for coronavirus (CoViD-19) admitted into different isolation centres in Nigeria
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The identification and selection of participants will be done by none of investigators. Allocation into group will also be done by none of the investigators. Outcome assessment will be done by none of the investigators. Participants will not be privy to another group
measure: Cycle Threshold (CT) values as recorded from the series of the qRT-PCR
time frame: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
description: The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement
measure: Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR
time frame: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
description: This is the inverse of the Cycle Threshold. It does not have unit of measurement.
measure: Quality of Life perception
time frame: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
description: Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.
measure: Exercise capacity
time frame: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
description: The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds
measure: Exercise endurance
time frame: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
description: The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres
arm group label: Stroke survivors with COVID19
arm group type: Experimental
description: The active intervention group
arm group label: Non-stroke individuals with COVID19
arm group type: Placebo Comparator
description: Matching for age, sex and co-morbid status with the stroke survivors
intervention type: Other
intervention name: Rehabilitation exercise protocol
description: The exercise package will then be sent to them after securing video contact with the prospective participant. Only participants with smart phone that can receive the video package will be selected for this study.
Physiotherapy-Patients' Engagements At every morning after their prescribed drugs might have been served in the ward, the physiotherapist will call the participant for the exercises. The patient will be connected to the physiotherapist who is in his clinic (not in the isolation ward with the patients) through a WhatsApp or zoom video call. The physiotherapist will control the rhythm and pace of the exercises through the video interactions.
arm group label: Non-stroke individuals with COVID19
arm group label: Stroke survivors with COVID19
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Caleb AO Gbiri, PhD
role: Principal Investigator
affiliation: University of Lagos, Nigeria
last name: Caleb AO Gbiri, PhD
phone: +2347084567759
email: cgbiri@unilag.edu.ng
last name: Jibrin S Usman, MSc
phone: +2348069766797
email: jibrilphysio@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: University of Lagos, Nigeria
investigator full name: Caleb Ademola Omuwa Gbiri
investigator title: Senior Lecturer and Neurophysiotherapist
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Stroke
sharing ipd: Yes
ipd description: Share with the participants
=Share through public lecture
Share through publication in peer review journals
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: For data merging and comparison
ipd access criteria: on demand
ipd url: http://www.snersdfoundation.com.ng