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Completed

NCT Number: NCT05565872

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zona Básica de Salud Torrejón de Ardoz

Torrejón de Ardoz, Madrid, 28850, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Urban training

Behavioral

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

Primary outcomes

  1. 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

  1. Change in physical activity

    Time frame: 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

  2. Change in quality of life

    Time frame: 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

  3. Change in anxiety and depression symptoms

    Time frame: 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.

  4. COPD exacerbations

    Time frame: 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 outcomes

  1. The effect of an attendance at an urban training program on changes in self-efficacy

    Time frame: 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.

  2. Adherence to treatment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Gerencia de Atención Primaria, Madrid
  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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