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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2024-07-10

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.

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Lung Diseases, Obstructive Respiratory Tract Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Urban training

Intervention Type BEHAVIORAL

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

Urban training Intervention + therapeutic education program with telematic supervision

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

Group Type ACTIVE_COMPARATOR

Urban training

Intervention Type BEHAVIORAL

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

Interventions

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Urban training

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

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No