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

Universidad Complutense de Madrid

Status: Completed

Conditions: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease; Respiratory Tract Diseases

Treatments: Behavioral: Urban training

Study type: Interventional

Funder types: Other

Identifiers

NCT05565872

22/126-EC_X_Tesis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: Urban training

Urban training Intervention + therapeutic education program with telematic supervision

Active Comparator group

Description:

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

Treatment:

Behavioral: Urban training