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

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05565872

Collaborator

Sociedad Española de Neumología y Cirugía Torácica (Other), Gerencia de Atención Primaria, Madrid (Other)

Enrollment

Location

Arms

25.4

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Lung Diseases, Obstructive Respiratory Tract Diseases	Behavioral: Urban training	N/A

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

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2022

Anticipated Primary Completion Date :

Nov 15, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Urban training Intervention + therapeutic education program with face-to-face supervision

Patients will be advised to walk in the defined urban trails with face-to-face supervision

Behavioral: Urban training

A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities

Active Comparator: Urban training Intervention + therapeutic education program with telematic supervision

Patients will be advised to walk in the defined urban trails with telematic supervision

Behavioral: Urban training

A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)