Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD

Study Overview
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Brief Summary
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This project plans on a community-based exercise intervention (Urban Training) combined with therapeutic education program, by using public spaces and urban walkable trails, adapted to each patient needs and capabilities in patients with chronic obstructive pulmonary disease (COPD). The main objective of the present study is to evaluate the effects comparing different levels of supervision (face-to-face vs telematic) in the short-, medium- and long-term with respect to: (primary outcome): exercise capacity, and (secondary outcomes): physical activity, quality of life, mental health and COPD exacerbations.

Detailed Description
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It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: (1) Urban training Intervention + therapeutic education program with face-to-face supervision, (2) Urban training Intervention + therapeutic education program with telematic supervision Each exercise training program will be applied once per day, 3 sessions per week during 12 weeks. The group with Urban training Intervention with face-to-face supervision will be supervised by a physiotherapist once a week. The group with Urban training Intervention with telematic supervision will be supervised by a phone call once a week. To record compliance, participants from all groups were asked to complete a diary at the end of every training session. The therapeutic education program will consisted of 1 session/week during 4 weeks. Participants received baseline assessments at the beginning of the intervention, post-intervention assessments at the end of the 13th week, 6 months of follow-up and 12 months of follow-up.

Official Title
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Effects of Face-to-face Versus Telematic Supervision During a Community-based Exercise Intervention (Urban Training) Plus Therapeutic Education Programme on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive, Respiratory Tract Diseases

Intervention / Treatment
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* Behavioral: Urban training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70 Clinical stability, defined as at least 6 weeks without COPD exacerbation Exclusion Criteria: Neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered they ability to cooperate Comorbidity that could interfere with study intervention (e.g., severe orthopaedic problems) Previous inclusion in a rehabilitation programme (previous 6 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urban training Intervention + therapeutic education program with face-to-face supervision<br>Patients will be advised to walk in the defined urban trails with face-to-face supervision | Behavioral: Urban training<br>* A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities<br>|
| Active Comparator: Urban training Intervention + therapeutic education program with telematic supervision<br>Patients will be advised to walk in the defined urban trails with telematic supervision | Behavioral: Urban training<br>* A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity | Change in exercise capacity between baseline, up to 13 weeks, 6 months and 12 months, as measured by 6-min walking distance | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Change in physical activity between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured during 1 week by accelerometer | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | 
| Change in quality of life | Change in quality of life between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured by COPD Assessment Test | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | 
| Change in anxiety and depression symptoms | Change in anxiety and depression symptoms between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured by the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into 2 subscales for anxiety and depression. Each item is scored on a 4-point Likert scale ranging from 0 to 3, with scores ranging from 0 to 42 and an optimal cut-off score of ≥13. | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | 
| COPD exacerbations | Number and duration of COPD exacerbations, and admissions to emergency-room or hospital | Post-intervention (up to 13 weeks), 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Telerehabilitation, Exercise Tolerance, Physical Activity