xml: <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/NCT06035263</url>
    </required_header>
    <id_info>
      <org_study_id>University of Salamanca 2</org_study_id>
      <nct_id>NCT06035263</nct_id>
    </id_info>
    <brief_title>Effects of a Functional Re-education and Environmental Adaptation Programme in Cancer Patients With Associated Respiratory Pathology</brief_title>
    <official_title>Effects of a Functional Re-education and Environmental Adaptation Programme on Levels of Dependency, Dyspnoea, Functional Capacity, Quality of Life and Caregiver Burden in Cancer Patients With Associated Respiratory Pathology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Salamanca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Salamanca</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 investigators propose an interdisciplinary intervention, carried out by occupational&#xD;
        therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed&#xD;
        at improving conventional clinical practice and implementing a programme of functional&#xD;
        re-education and environmental adaptation that implements conventional clinical practice, and&#xD;
        which the investigators also consider to be an essential intervention in the follow-up of&#xD;
        patients with associated respiratory pathology once they are discharged from hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, improvements in oncological treatments, together with a strong commitment to&#xD;
        preventive strategies, have led to better early diagnosis and better knowledge of the&#xD;
        oncological pathology itself, resulting in an exponential increase in the survival of cancer&#xD;
        patients. All of this has led to the increasing importance of the concept of &quot;long&#xD;
        survivorship&quot;.&#xD;
  &#xD;
        Along with this increase in survival and the resulting increase in the number of lines of&#xD;
        treatment used, there has been an increase in side effects that negatively impact aspects&#xD;
        such as functionality or quality of life in patients. Some of these effects may include&#xD;
        tumour asthenia, anxiety or associated respiratory pathology (dyspnoea). In some patients&#xD;
        with advanced cancer, dyspnoea may be a clinical sign of end-stage disease. Approximately 41%&#xD;
        of palliative care patients have dyspnoea and 46% of these describe it as moderate or severe.&#xD;
        Furthermore, this incidence increases significantly in patients with an anatomopathological&#xD;
        diagnosis of lung cancer, reaching incidences of more than 73% in various studies.&#xD;
  &#xD;
        Most patients perceive this dyspnoea as a limiting factor beyond their control, leading to&#xD;
        avoidance behaviours that further increase their inactivity. This inevitably has a negative&#xD;
        impact on their functionality and leads to patterns of fear/avoidance of exercise in cancer&#xD;
        patients, as seen in patients with chronic pain, chronic fatigue syndrome or fibromyalgia.&#xD;
        Patients with respiratory problems adapt to their symptoms by reducing their activity levels.&#xD;
        This leads to a deterioration in physical fitness and exertional dyspnoea, known as the&#xD;
        &quot;respiratory patient cycle&quot;.&#xD;
  &#xD;
        For the control of dyspnoea, the investigators believe that the measures used in conventional&#xD;
        clinical practice, developed mainly from a pharmacological point of view, can be implemented,&#xD;
        but that they are not sufficient to achieve optimal symptomatic control.&#xD;
  &#xD;
        Current pharmacological treatment does not always manage to control the main symptom of&#xD;
        respiratory pathologies: dyspnoea, perhaps because of its multifactorial nature. Most&#xD;
        patients perceive this symptom as a limiting factor beyond their control, leading them to&#xD;
        adopt avoidance behaviours that increase their inactivity, with negative consequences for&#xD;
        their functionality. Therefore, from the point of view of comprehensive care for the patient,&#xD;
        not only for the symptom, the investigators have observed that it is necessary to use other&#xD;
        interventions that achieve the patient's readaptation to their daily activity.&#xD;
  &#xD;
        the investigators have observed that cancer patients with respiratory pathology adapt to&#xD;
        their symptoms by reducing their level of activity. This leads to a deterioration in their&#xD;
        physical condition and dyspnoea on exertion. Dyspnoea leads to progressive disability with&#xD;
        loss of mobility, self-esteem, work and social relationships.&#xD;
  &#xD;
        These data show that associated respiratory pathology is a common problem in oncology, which&#xD;
        is still underestimated by professionals. It has been observed that people with this process&#xD;
        find it difficult to normalise their daily lives, either because of a deterioration in their&#xD;
        clinical condition or because of a problem in generalising what they have learned during&#xD;
        their hospital stay.&#xD;
  &#xD;
        In terms of intervention, the NCCN panel considers education and energy conservation&#xD;
        techniques to be fundamental, always within a complete functional rehabilitation programme.&#xD;
  &#xD;
        In addition to educational measures, the NCCN panel recommends the prescription of energy&#xD;
        conservation techniques, presenting them as useful in controlling this associated respiratory&#xD;
        pathology. To this end, the panel analyses, on the one hand, a multicentre clinical trial&#xD;
        involving 296 patients currently under active treatment, in whom a reduction in symptom&#xD;
        intensity was reported after application of the programme. On the other hand, they present a&#xD;
        meta-analysis including 113 studies with a total sample of 11,525 patients, showing an&#xD;
        improvement in individuals after the use of non-pharmacological measures to control&#xD;
        associated respiratory pathology (weighted effect size, 0.30; 95% CI, 0.25-0.36; p&lt;0.001).&#xD;
  &#xD;
        The common presence of associated respiratory pathology in cancer patients is a factor that&#xD;
        can cause changes in body composition, such as loss of muscle mass or an increase in visceral&#xD;
        fat. This type of non-pharmacological intervention has been shown to be an important tool in&#xD;
        improving symptoms and some parameters related to body composition. In the study by Madison&#xD;
        et al, moderate exercise (bioelectrical impedance) over 12 weeks was associated with a&#xD;
        reduction in body fat in colorectal cancer survivors. Another study showed that an 8-week&#xD;
        exercise intervention increased skeletal muscle mass and decreased visceral fat in a group of&#xD;
        head and neck cancer patients undergoing chemotherapy. Fernandez-Lao et al showed that a&#xD;
        multimodal exercise programme in breast cancer patients led to a reduction in body fat and an&#xD;
        increase in lean body mass in a group of breast cancer patients. However, despite the&#xD;
        potential effects, there is little evidence of functional rehabilitation interventions that&#xD;
        have assessed the effects on body composition in patients with associated respiratory&#xD;
        pathology.&#xD;
  &#xD;
        The scientific evidence and recent conclusions of expert meetings on cancer and the benefits&#xD;
        of these psychosocial interventions, both in the prevention and treatment of the different&#xD;
        clinical aspects of cancer survivors or patients undergoing cancer treatment, point to the&#xD;
        existence of sufficient evidence to support their efficacy in addressing physical function,&#xD;
        fatigue, quality of life, pain, anxiety and depressive symptoms, among others, related to&#xD;
        cancer.&#xD;
  &#xD;
        Non-pharmacological psychosocial interventions have therefore been shown to be even more&#xD;
        effective than pharmacological interventions in addressing these associated symptoms, leading&#xD;
        us to consider the bio-psychosocial approach and multidisciplinary intervention (oncology,&#xD;
        nursing, physiotherapy, occupational therapy and medicine) as the global context of&#xD;
        intervention. For this reason, aspects related to loss of function and pain associated with&#xD;
        anxiety-avoidance disorders should also be assessed and addressed, which can be assessed&#xD;
        using kinesiophobia scores.&#xD;
  &#xD;
        The cognitive-behavioural model of fear of exercise suggests that patients with chronic pain&#xD;
        or fatigue syndrome tend to avoid activity because they believe that activity is the cause of&#xD;
        these symptoms, such as pain and fatigue. Avoidance behaviour leads to even greater fear and&#xD;
        symptoms, resulting in more pain or fatigue, which may extend to patients with associated&#xD;
        respiratory pathology, so it is important to restore optimal activity levels and avoid loss&#xD;
        of physical function and ability.&#xD;
  &#xD;
        The choice of the most appropriate intervention setting is based on clinical complexity and&#xD;
        the patient's ability to self-manage their situation. For this reason, and with the support&#xD;
        of experts, our study proposes a supervised intervention in the home setting after hospital&#xD;
        discharge, adapted to the specific situation of patients with associated respiratory&#xD;
        pathology who have just been discharged from hospital. This is in line with recommendations&#xD;
        to improve and increase access and adherence to a functional rehabilitation programme for&#xD;
        these patients.&#xD;
  &#xD;
        Supervised follow-up outside the healthcare setting, both in the community and at home, has&#xD;
        been shown to be successful in previous trials. This is shown in a meta-analysis of 14&#xD;
        randomised controlled clinical trials in breast cancer survivors with supervised intervention&#xD;
        by telephone or e-mail. In any case, despite the choice of the home setting for its&#xD;
        feasibility in our study population, supervision and controlled follow-up of the intervention&#xD;
        is still a guarantee of good results, as shown in another recent meta-analysis of 128 trials&#xD;
        with a total of 13,050 cancer patients, where supervised programmes had greater effects on&#xD;
        physical activity. Follow-up is important not only for the correct implementation of the&#xD;
        intervention programme, but also for achieving high adherence to the programme, as shown in a&#xD;
        review of 23 trials and 1372 patients.&#xD;
  &#xD;
        The best results in patients surviving or undergoing cancer treatment have been obtained with&#xD;
        multimodal exercise programmes that combine different types of exercise, mainly aerobic and&#xD;
        strength training, in addition to other interventions such as reeducation in activities of&#xD;
        daily living and health education, adapted to the patient's general condition and functional&#xD;
        capacity.&#xD;
  &#xD;
        For this reason, the investigators propose an interdisciplinary intervention, carried out by&#xD;
        occupational therapists, nurses, physiotherapists and doctors specialised in this type of&#xD;
        patient, aimed at improving conventional clinical practice and implementing a programme of&#xD;
        functional re-education and environmental adaptation that implements conventional clinical&#xD;
        practice, and which the investigators also consider to be an essential intervention in the&#xD;
        follow-up of patients with associated respiratory pathology once they are discharged from&#xD;
        hospital.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Subjects will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which each elderly centre is assigned, so the clinical trial will have a masking of the blinded assessment by third parties.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Activities of daily living</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>Barthel Index</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>dyspnoea</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>Medical Research Council Dyspnoea: Scores: (0, best - 4, worst)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>EuroQol 5-D questionnaire. Scores: ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Pain</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>Visual Analogue Scale. Scores: ranging from 0 (lowest degree of pain) to 10 (highest degree of pain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical performance assessment</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>Short Physical Performance Battery. The total SPPB score is the sum of the three sub-tests and ranges from 0 (worst) to 12. Changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain/fatigue-related fear of movement</measure>
      <time_frame>Baseline; 1 week (follow up); 2 weeks (final)</time_frame>
      <description>Tampa Scale for Kinesiophobia. The results are obtained by means of a total raw score (which can range from 17 to 68) and two subscale scores.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Cancer</condition>
    <condition>Dyspnea</condition>
    <condition>Functionality</condition>
    <condition>Quality of Life</condition>
    <condition>Functional Capacity</condition>
    <arm_group>
      <arm_group_label>FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health education programme:</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.&#xD;
  They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME</intervention_name>
      <description>the prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.</description>
      <arm_group_label>FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Health education programme:</intervention_name>
      <description>instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.&#xD;
  They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.</description>
      <arm_group_label>Health education programme:</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To have, among the reasons for admission, an anatomopathological diagnosis of newly&#xD;
               diagnosed or relapsed oncological disease.&#xD;
  &#xD;
            -  To be admitted to the Oncology Department of the University Hospital of Salamanca.&#xD;
  &#xD;
            -  Moderate to severe dependency: Barthel Index score between 20 and 55 points.&#xD;
  &#xD;
            -  Sign an informed consent form authorising their voluntary participation in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) of less&#xD;
               than 24 points.&#xD;
  &#xD;
            -  Haemoglobin level of less than 10g/dl.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Eduardo Jose Fernandez Rodriguez</name>
        <address>
          <city>Salamanca</city>
          <state>Castilla Y Leon</state>
          <zip>37002</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eduardo PhD Fernandez, PhD</last_name>
        <phone>923294500</phone>
        <email>edujfr@usal.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Salamanca</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Eduardo J Fernández Rodríguez</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Functional Status</keyword>
    <keyword>Cancer</keyword>
    <keyword>Dyspnea</keyword>
    <keyword>Quality of Life</keyword>
    <keyword>Occupational therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035263
  org study id: University of Salamanca 2
  nct id: NCT06035263
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  the investigators propose an interdisciplinary intervention, carried out by occupational
        therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed
        at improving conventional clinical practice and implementing a programme of functional
        re-education and environmental adaptation that implements conventional clinical practice, and
        which the investigators also consider to be an essential intervention in the follow-up of
        patients with associated respiratory pathology once they are discharged from hospital.
  In recent years, improvements in oncological treatments, together with a strong commitment to
        preventive strategies, have led to better early diagnosis and better knowledge of the
        oncological pathology itself, resulting in an exponential increase in the survival of cancer
        patients. All of this has led to the increasing importance of the concept of "long
        survivorship".
  
        Along with this increase in survival and the resulting increase in the number of lines of
        treatment used, there has been an increase in side effects that negatively impact aspects
        such as functionality or quality of life in patients. Some of these effects may include
        tumour asthenia, anxiety or associated respiratory pathology (dyspnoea). In some patients
        with advanced cancer, dyspnoea may be a clinical sign of end-stage disease. Approximately 41%
        of palliative care patients have dyspnoea and 46% of these describe it as moderate or severe.
        Furthermore, this incidence increases significantly in patients with an anatomopathological
        diagnosis of lung cancer, reaching incidences of more than 73% in various studies.
  
        Most patients perceive this dyspnoea as a limiting factor beyond their control, leading to
        avoidance behaviours that further increase their inactivity. This inevitably has a negative
        impact on their functionality and leads to patterns of fear/avoidance of exercise in cancer
        patients, as seen in patients with chronic pain, chronic fatigue syndrome or fibromyalgia.
        Patients with respiratory problems adapt to their symptoms by reducing their activity levels.
        This leads to a deterioration in physical fitness and exertional dyspnoea, known as the
        "respiratory patient cycle".
  
        For the control of dyspnoea, the investigators believe that the measures used in conventional
        clinical practice, developed mainly from a pharmacological point of view, can be implemented,
        but that they are not sufficient to achieve optimal symptomatic control.
  
        Current pharmacological treatment does not always manage to control the main symptom of
        respiratory pathologies: dyspnoea, perhaps because of its multifactorial nature. Most
        patients perceive this symptom as a limiting factor beyond their control, leading them to
        adopt avoidance behaviours that increase their inactivity, with negative consequences for
        their functionality. Therefore, from the point of view of comprehensive care for the patient,
        not only for the symptom, the investigators have observed that it is necessary to use other
        interventions that achieve the patient's readaptation to their daily activity.
  
        the investigators have observed that cancer patients with respiratory pathology adapt to
        their symptoms by reducing their level of activity. This leads to a deterioration in their
        physical condition and dyspnoea on exertion. Dyspnoea leads to progressive disability with
        loss of mobility, self-esteem, work and social relationships.
  
        These data show that associated respiratory pathology is a common problem in oncology, which
        is still underestimated by professionals. It has been observed that people with this process
        find it difficult to normalise their daily lives, either because of a deterioration in their
        clinical condition or because of a problem in generalising what they have learned during
        their hospital stay.
  
        In terms of intervention, the NCCN panel considers education and energy conservation
        techniques to be fundamental, always within a complete functional rehabilitation programme.
  
        In addition to educational measures, the NCCN panel recommends the prescription of energy
        conservation techniques, presenting them as useful in controlling this associated respiratory
        pathology. To this end, the panel analyses, on the one hand, a multicentre clinical trial
        involving 296 patients currently under active treatment, in whom a reduction in symptom
        intensity was reported after application of the programme. On the other hand, they present a
        meta-analysis including 113 studies with a total sample of 11,525 patients, showing an
        improvement in individuals after the use of non-pharmacological measures to control
        associated respiratory pathology (weighted effect size, 0.30; 95% CI, 0.25-0.36; p<0.001).
  
        The common presence of associated respiratory pathology in cancer patients is a factor that
        can cause changes in body composition, such as loss of muscle mass or an increase in visceral
        fat. This type of non-pharmacological intervention has been shown to be an important tool in
        improving symptoms and some parameters related to body composition. In the study by Madison
        et al, moderate exercise (bioelectrical impedance) over 12 weeks was associated with a
        reduction in body fat in colorectal cancer survivors. Another study showed that an 8-week
        exercise intervention increased skeletal muscle mass and decreased visceral fat in a group of
        head and neck cancer patients undergoing chemotherapy. Fernandez-Lao et al showed that a
        multimodal exercise programme in breast cancer patients led to a reduction in body fat and an
        increase in lean body mass in a group of breast cancer patients. However, despite the
        potential effects, there is little evidence of functional rehabilitation interventions that
        have assessed the effects on body composition in patients with associated respiratory
        pathology.
  
        The scientific evidence and recent conclusions of expert meetings on cancer and the benefits
        of these psychosocial interventions, both in the prevention and treatment of the different
        clinical aspects of cancer survivors or patients undergoing cancer treatment, point to the
        existence of sufficient evidence to support their efficacy in addressing physical function,
        fatigue, quality of life, pain, anxiety and depressive symptoms, among others, related to
        cancer.
  
        Non-pharmacological psychosocial interventions have therefore been shown to be even more
        effective than pharmacological interventions in addressing these associated symptoms, leading
        us to consider the bio-psychosocial approach and multidisciplinary intervention (oncology,
        nursing, physiotherapy, occupational therapy and medicine) as the global context of
        intervention. For this reason, aspects related to loss of function and pain associated with
        anxiety-avoidance disorders should also be assessed and addressed, which can be assessed
        using kinesiophobia scores.
  
        The cognitive-behavioural model of fear of exercise suggests that patients with chronic pain
        or fatigue syndrome tend to avoid activity because they believe that activity is the cause of
        these symptoms, such as pain and fatigue. Avoidance behaviour leads to even greater fear and
        symptoms, resulting in more pain or fatigue, which may extend to patients with associated
        respiratory pathology, so it is important to restore optimal activity levels and avoid loss
        of physical function and ability.
  
        The choice of the most appropriate intervention setting is based on clinical complexity and
        the patient's ability to self-manage their situation. For this reason, and with the support
        of experts, our study proposes a supervised intervention in the home setting after hospital
        discharge, adapted to the specific situation of patients with associated respiratory
        pathology who have just been discharged from hospital. This is in line with recommendations
        to improve and increase access and adherence to a functional rehabilitation programme for
        these patients.
  
        Supervised follow-up outside the healthcare setting, both in the community and at home, has
        been shown to be successful in previous trials. This is shown in a meta-analysis of 14
        randomised controlled clinical trials in breast cancer survivors with supervised intervention
        by telephone or e-mail. In any case, despite the choice of the home setting for its
        feasibility in our study population, supervision and controlled follow-up of the intervention
        is still a guarantee of good results, as shown in another recent meta-analysis of 128 trials
        with a total of 13,050 cancer patients, where supervised programmes had greater effects on
        physical activity. Follow-up is important not only for the correct implementation of the
        intervention programme, but also for achieving high adherence to the programme, as shown in a
        review of 23 trials and 1372 patients.
  
        The best results in patients surviving or undergoing cancer treatment have been obtained with
        multimodal exercise programmes that combine different types of exercise, mainly aerobic and
        strength training, in addition to other interventions such as reeducation in activities of
        daily living and health education, adapted to the patient's general condition and functional
        capacity.
  
        For this reason, the investigators propose an interdisciplinary intervention, carried out by
        occupational therapists, nurses, physiotherapists and doctors specialised in this type of
        patient, aimed at improving conventional clinical practice and implementing a programme of
        functional re-education and environmental adaptation that implements conventional clinical
        practice, and which the investigators also consider to be an essential intervention in the
        follow-up of patients with associated respiratory pathology once they are discharged from
        hospital.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Subjects will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which each elderly centre is assigned, so the clinical trial will have a masking of the blinded assessment by third parties.
  measure: Activities of daily living
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: Barthel Index
  measure: dyspnoea
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: Medical Research Council Dyspnoea: Scores: (0, best - 4, worst)
  measure: Health-related quality of life
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: EuroQol 5-D questionnaire. Scores: ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health).
  measure: General Pain
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: Visual Analogue Scale. Scores: ranging from 0 (lowest degree of pain) to 10 (highest degree of pain).
  measure: Physical performance assessment
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: Short Physical Performance Battery. The total SPPB score is the sum of the three sub-tests and ranges from 0 (worst) to 12. Changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
  measure: pain/fatigue-related fear of movement
  time frame: Baseline; 1 week (follow up); 2 weeks (final)
  description: Tampa Scale for Kinesiophobia. The results are obtained by means of a total raw score (which can range from 17 to 68) and two subscale scores.
  arm group label: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME
  arm group type: Experimental
  description: prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.
  arm group label: Health education programme:
  arm group type: Active Comparator
  description: instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.
  They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.
  intervention type: Other
  intervention name: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME
  description: the prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.
  arm group label: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME
  intervention type: Other
  intervention name: Health education programme:
  description: instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.
  They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.
  arm group label: Health education programme:
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: University of Salamanca
  investigator full name: Prof. Dr. Eduardo J Fernández Rodríguez
  investigator title: Professor
  mesh term: Dyspnea