<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/NCT04482634</url>
  </required_header>
  <id_info>
    <org_study_id>2020.219.IRB1.069</org_study_id>
    <nct_id>NCT04482634</nct_id>
  </id_info>
  <brief_title>Tele-rehabilitation Versus Home Exercise Program in COVID-19</brief_title>
  <official_title>Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Koç University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Koç University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of the study is to investigate the potential effects of face-to-face supervised&#xD;
      tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle&#xD;
      endurance, quality of life, physical activity level and perceived respiratory disability in&#xD;
      COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 could cause respiratory distress in a minority of cases and requires intensive care&#xD;
      and mechanical ventilation. When patients recover and are discharged from hospital, physical,&#xD;
      cognitive and emotional complications known as post-intensive care syndrome is seen in the&#xD;
      majority of patients and requires rehabilitation.&#xD;
&#xD;
      Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient,&#xD;
      exercise training and education in order to improve physical and psychological condition of&#xD;
      people with chronic respiratory disease.&#xD;
&#xD;
      The patients with COVID-19 with post-intensive care syndrome will be randomized two groups:&#xD;
      Tele-rehabilitation group and home exercise group. There will not be a non-exercising control&#xD;
      group due to the ethical issues. The exercise program of both groups will be prescribed by a&#xD;
      physiatrist based on the physical examination and the functional capacity of the patients.&#xD;
&#xD;
      Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One&#xD;
      session will include aerobic, flexibility and strengthening exercises for lower and upper&#xD;
      extremity and breathing exercise.&#xD;
&#xD;
      The trainings will start with low-intensity exercises and intensity and duration of the&#xD;
      exercises will progress according to the condition of the patient.&#xD;
&#xD;
      Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion&#xD;
      symptoms during the sessions.&#xD;
&#xD;
      Home exercise group will perform the exercises at their home on their own, 3 days/week for 10&#xD;
      weeks. The patients will be trained about the individualised exercise program as the first&#xD;
      session provided at the hospital. The physiotherapist will call the patients weekly,&#xD;
      modifications in the exercise program will be made according to the patient's reports.&#xD;
&#xD;
      Outcomes will be measured at baseline, within 1 week of completion the program, 6th months&#xD;
      and 12th months following the rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>There will be two groups. The first group will perform the exercises at their home under remote supervision (tele-rehabilitation group) and the second group will perform the exercises at their home on their own (home exercise group)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>12 months</time_frame>
    <description>This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six-minute walking distance will be recorded. Higher walking distance shows better outcome. Minimal clinical difference is 20-30 meter in patients surviving acute respiratory distress syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short form - 36</measure>
    <time_frame>12 months</time_frame>
    <description>Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair- stand test</measure>
    <time_frame>12 months</time_frame>
    <description>Chair stand test will be used to evaluate strength and endurance of lower limbs. Patients will be asked to sit on a chair by crossing their hands over their chest and sit five times consecutively as fast as possible. The test will be started in the sitting position and terminated at the last standing position and the time will be recorded. The test will be carried out 2 times and the best grade obtained will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>12 months</time_frame>
    <description>To assess physical function/performance, timed up and go test will be performed. It is an objective, reliable and simple test to evaluate balance and functional movement. The patient will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time will be recorded in seconds. The test will be started and ended when the patient sit on the chair with back supported. It predicts mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. George's Respiratory Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>St. George's Respiratory Questionnaire is a 50-item questionnaire with 76 weighted responses that is developed to measure health status/ quality of life in patients with airway diseases. It consists of 3 sections; symptoms (8 item), activity (16 item) and impact of the disease (26 item). Each of the 3 sections is scored separately and a summary total score is calculated using weights attached to each item in the range 0 to 100. 0 indicates best possible health status and 100 indicates worst possible health status. A minimum change in score of 4 units was established as clinically relevant. Turkish reliability of the questionnaire is exist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The COPD Assessment Test</measure>
    <time_frame>12 months</time_frame>
    <description>The COPD Assessment Test evaluates 8 parameters for measuring the impact of COPD on a patient's life and how changes over time. It provides a scoring range of 0-40, higher score indicates worst health. Turkish validity and reliability of the test is exist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Research Council Dyspnea Scale</measure>
    <time_frame>12 months</time_frame>
    <description>The Medical Research Council Dyspnea Scale is a simple method measuring perceived respiratory disability of COPD patients. It consists of 5 items from 0 to 4. 0 indicates normal, 4 indicates worst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength</measure>
    <time_frame>12 months</time_frame>
    <description>Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients and correlates with 6 minute walk distance in subjects with COPD exacerbation. Handgrip strength will be measured using a handheld dynamometer (JAMAR Plus+ electronic dynamometer, part number: 563213, serial number: 2019070814) according to the instructions of the American Society of Hand Therapists. Patients will be seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients will be asked to grip the dynamometer with maximally to measure maximal grip strength (in kg) for the dominant hand with standard verbal encouragement. Three trials will be performed with a 30 sec rest between trials and the highest value will be recorded. The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Pulmonary Rehabilitation</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Tele-rehabilitation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will perform the exercises at their home on their own, the first exercise program will be given at hospital and the patients will be followed up regular weekly by phone call.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remote controlled exercise</intervention_name>
    <description>Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.</description>
    <arm_group_label>Tele-rehabilitation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise</intervention_name>
    <description>Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.</description>
    <arm_group_label>Home exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be older than 18 years&#xD;
&#xD;
          -  To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19&#xD;
&#xD;
          -  To have ability to walk independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or&#xD;
             visual impairment that might interfere to follow the instructions&#xD;
&#xD;
          -  To have a severe co-morbidity that exercise is contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozden Ozyemisci Taskiran, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Koc University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ihsan Solaroglu, Prof</last_name>
    <phone>+ 90 212 338 10 39</phone>
    <email>isolaroglu@ku.edu.tr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Baris Ata, Prof</last_name>
    <phone>+ 90 212 338 10 39</phone>
    <email>bata@ku.edu.tr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Koc University School of Medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34010</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ihsan Solaroglu, Prof</last_name>
      <phone>+ 90 212 338 10</phone>
      <email>isolaroglu@ku.edu.tr</email>
    </contact>
    <contact_backup>
      <last_name>Baris Ata, Prof</last_name>
      <phone>+ 90 212 338 10</phone>
      <email>bata@ku.edu.tr</email>
    </contact_backup>
    <investigator>
      <last_name>Ozden Ozyemisci Taskiran, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zeynep Turan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mahir Topaloglu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Held N, Moss M. Optimizing Post-Intensive Care Unit Rehabilitation. Turk Thorac J. 2019 Apr 1;20(2):147-152. doi: 10.5152/TurkThoracJ.2018.18172. Print 2019 Apr.</citation>
    <PMID>30958989</PMID>
  </results_reference>
  <results_reference>
    <citation>Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.</citation>
    <PMID>24127811</PMID>
  </results_reference>
  <results_reference>
    <citation>Lau HM, Ng GY, Jones AY, Lee EW, Siu EH, Hui DS. A randomised controlled trial of the effectiveness of an exercise training program in patients recovering from severe acute respiratory syndrome. Aust J Physiother. 2005;51(4):213-9. doi: 10.1016/s0004-9514(05)70002-7.</citation>
    <PMID>16321128</PMID>
  </results_reference>
  <results_reference>
    <citation>Bourne S, DeVos R, North M, Chauhan A, Green B, Brown T, Cornelius V, Wilkinson T. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial. BMJ Open. 2017 Jul 17;7(7):e014580. doi: 10.1136/bmjopen-2016-014580.</citation>
    <PMID>28716786</PMID>
  </results_reference>
  <results_reference>
    <citation>Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.</citation>
    <PMID>31190519</PMID>
  </results_reference>
  <results_reference>
    <citation>Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.</citation>
    <PMID>10377201</PMID>
  </results_reference>
  <results_reference>
    <citation>Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.</citation>
    <PMID>19720809</PMID>
  </results_reference>
  <results_reference>
    <citation>Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.</citation>
    <PMID>1595997</PMID>
  </results_reference>
  <results_reference>
    <citation>Bergland A, Jorgensen L, Emaus N, Strand BH. Mobility as a predictor of all-cause mortality in older men and women: 11.8 year follow-up in the Tromso study. BMC Health Serv Res. 2017 Jan 10;17(1):22. doi: 10.1186/s12913-016-1950-0.</citation>
    <PMID>28068995</PMID>
  </results_reference>
  <results_reference>
    <citation>Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.</citation>
    <PMID>27716195</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>COVID-19</keyword>
  <keyword>pulmonary exercise</keyword>
  <keyword>post-intensive care syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04482634
org study id: 2020.219.IRB1.069
nct id: NCT04482634
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the potential effects of face-to-face supervised
      tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle
      endurance, quality of life, physical activity level and perceived respiratory disability in
      COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.
COVID-19 could cause respiratory distress in a minority of cases and requires intensive care
      and mechanical ventilation. When patients recover and are discharged from hospital, physical,
      cognitive and emotional complications known as post-intensive care syndrome is seen in the
      majority of patients and requires rehabilitation.

      Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient,
      exercise training and education in order to improve physical and psychological condition of
      people with chronic respiratory disease.

      The patients with COVID-19 with post-intensive care syndrome will be randomized two groups:
      Tele-rehabilitation group and home exercise group. There will not be a non-exercising control
      group due to the ethical issues. The exercise program of both groups will be prescribed by a
      physiatrist based on the physical examination and the functional capacity of the patients.

      Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One
      session will include aerobic, flexibility and strengthening exercises for lower and upper
      extremity and breathing exercise.

      The trainings will start with low-intensity exercises and intensity and duration of the
      exercises will progress according to the condition of the patient.

      Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion
      symptoms during the sessions.

      Home exercise group will perform the exercises at their home on their own, 3 days/week for 10
      weeks. The patients will be trained about the individualised exercise program as the first
      session provided at the hospital. The physiotherapist will call the patients weekly,
      modifications in the exercise program will be made according to the patient's reports.

      Outcomes will be measured at baseline, within 1 week of completion the program, 6th months
      and 12th months following the rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There will be two groups. The first group will perform the exercises at their home under remote supervision (tele-rehabilitation group) and the second group will perform the exercises at their home on their own (home exercise group)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 6-minute walk test
time frame: 12 months
description: This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six-minute walking distance will be recorded. Higher walking distance shows better outcome. Minimal clinical difference is 20-30 meter in patients surviving acute respiratory distress syndrome
measure: Short form - 36
time frame: 12 months
description: Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.
measure: Chair- stand test
time frame: 12 months
description: Chair stand test will be used to evaluate strength and endurance of lower limbs. Patients will be asked to sit on a chair by crossing their hands over their chest and sit five times consecutively as fast as possible. The test will be started in the sitting position and terminated at the last standing position and the time will be recorded. The test will be carried out 2 times and the best grade obtained will be recorded
measure: Timed up and go test
time frame: 12 months
description: To assess physical function/performance, timed up and go test will be performed. It is an objective, reliable and simple test to evaluate balance and functional movement. The patient will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time will be recorded in seconds. The test will be started and ended when the patient sit on the chair with back supported. It predicts mortality.
measure: St. George's Respiratory Questionnaire
time frame: 12 months
description: St. George's Respiratory Questionnaire is a 50-item questionnaire with 76 weighted responses that is developed to measure health status/ quality of life in patients with airway diseases. It consists of 3 sections; symptoms (8 item), activity (16 item) and impact of the disease (26 item). Each of the 3 sections is scored separately and a summary total score is calculated using weights attached to each item in the range 0 to 100. 0 indicates best possible health status and 100 indicates worst possible health status. A minimum change in score of 4 units was established as clinically relevant. Turkish reliability of the questionnaire is exist.
measure: The COPD Assessment Test
time frame: 12 months
description: The COPD Assessment Test evaluates 8 parameters for measuring the impact of COPD on a patient's life and how changes over time. It provides a scoring range of 0-40, higher score indicates worst health. Turkish validity and reliability of the test is exist.
measure: Medical Research Council Dyspnea Scale
time frame: 12 months
description: The Medical Research Council Dyspnea Scale is a simple method measuring perceived respiratory disability of COPD patients. It consists of 5 items from 0 to 4. 0 indicates normal, 4 indicates worst.
measure: Hand grip strength
time frame: 12 months
description: Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients and correlates with 6 minute walk distance in subjects with COPD exacerbation. Handgrip strength will be measured using a handheld dynamometer (JAMAR Plus+ electronic dynamometer, part number: 563213, serial number: 2019070814) according to the instructions of the American Society of Hand Therapists. Patients will be seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients will be asked to grip the dynamometer with maximally to measure maximal grip strength (in kg) for the dominant hand with standard verbal encouragement. Three trials will be performed with a 30 sec rest between trials and the highest value will be recorded. The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.
arm group label: Tele-rehabilitation group
arm group type: Active Comparator
description: This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection.
arm group label: Home exercise group
arm group type: Active Comparator
description: This group will perform the exercises at their home on their own, the first exercise program will be given at hospital and the patients will be followed up regular weekly by phone call.
intervention type: Other
intervention name: Remote controlled exercise
description: Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
arm group label: Tele-rehabilitation group
intervention type: Other
intervention name: Home exercise
description: Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
arm group label: Home exercise group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ozden Ozyemisci Taskiran, Prof
role: Principal Investigator
affiliation: Koc University School of Medicine
last name: Ihsan Solaroglu, Prof
phone: + 90 212 338 10 39
email: isolaroglu@ku.edu.tr
last name: Baris Ata, Prof
phone: + 90 212 338 10 39
email: bata@ku.edu.tr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Turkey
citation: Held N, Moss M. Optimizing Post-Intensive Care Unit Rehabilitation. Turk Thorac J. 2019 Apr 1;20(2):147-152. doi: 10.5152/TurkThoracJ.2018.18172. Print 2019 Apr.
PMID: 30958989
citation: Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
PMID: 24127811
citation: Lau HM, Ng GY, Jones AY, Lee EW, Siu EH, Hui DS. A randomised controlled trial of the effectiveness of an exercise training program in patients recovering from severe acute respiratory syndrome. Aust J Physiother. 2005;51(4):213-9. doi: 10.1016/s0004-9514(05)70002-7.
PMID: 16321128
citation: Bourne S, DeVos R, North M, Chauhan A, Green B, Brown T, Cornelius V, Wilkinson T. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial. BMJ Open. 2017 Jul 17;7(7):e014580. doi: 10.1136/bmjopen-2016-014580.
PMID: 28716786
citation: Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
PMID: 31190519
citation: Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PMID: 10377201
citation: Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PMID: 19720809
citation: Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
PMID: 1595997
citation: Bergland A, Jorgensen L, Emaus N, Strand BH. Mobility as a predictor of all-cause mortality in older men and women: 11.8 year follow-up in the Tromso study. BMC Health Serv Res. 2017 Jan 10;17(1):22. doi: 10.1186/s12913-016-1950-0.
PMID: 28068995
citation: Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
PMID: 27716195
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No