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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change in exercise capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Change in exercise capacity
Time Frame: 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 Outcomes
- Change in physical activity(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- Change in quality of life(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- Change in anxiety and depression symptoms(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- COPD exacerbations(Post-intervention (up to 13 weeks), 6 months and 12 months)
Investigators
Tamara del Corral Núñez-Flores
Principal Investigator
Universidad Complutense de Madrid