Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD
- Conditions
- Respiratory Tract DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: Urban training
- Registration Number
- NCT05565872
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Urban training Intervention + therapeutic education program with face-to-face supervision Urban training Patients will be advised to walk in the defined urban trails with face-to-face supervision Urban training Intervention + therapeutic education program with telematic supervision Urban training Patients will be advised to walk in the defined urban trails with telematic supervision
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zona Básica de Salud Torrejón de Ardoz
🇪🇸Torrejón De Ardoz, Madrid, Spain