Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive, Respiratory Tract Diseases
Conditions
Keywords
Exercise Therapy, Telerehabilitation, Exercise Tolerance, Physical Activity
Brief summary
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
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.
Interventions
BEHAVIORALUrban training
A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities
Sponsors
Sociedad Española de Neumología y Cirugía Torácica
Gerencia de Atención Primaria, Madrid
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | Change in exercise capacity between baseline, up to 13 weeks, 6 months and 12 months, as measured by 6-min walking distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | Change in physical activity between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured during 1 week by accelerometer |
| Change in quality of life | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | Change in quality of life between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured by COPD Assessment Test |
| Change in anxiety and depression symptoms | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | 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. |
| COPD exacerbations | Post-intervention (up to 13 weeks), 6 months and 12 months | Number and duration of COPD exacerbations, and admissions to emergency-room or hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| The effect of an attendance at an urban training program on changes in self-efficacy | Baseline, post-intervention (up to 13 weeks), 6 months and 12 months | Changes between baseline, up to 13 weeks, 6 months and 12 months follow-up in self-efficacy measured by the self-efficacy to regulate the exercise scale. |
| Adherence to treatment | Post-intervention (up to 13 weeks), 6 months and 12 months | Change in adherence to treatment between post-intervention (up to 13 weeks), 6 months and 12 months follow-up, as measured by the AdT-Physio scale (adherence to physical therapist intervention) |
Countries
Spain
Outcome results
None listed