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

November 20, 2024 updated by: Tamara del Corral Núñez-Flores, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Torrejón De Ardoz, Madrid, Spain, 28850
        • Zona Básica de Salud Torrejón de Ardoz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
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
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
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.
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
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
Post-intervention (up to 13 weeks), 6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
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)
Post-intervention (up to 13 weeks), 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

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

Investigators

  • Principal Investigator: Tamara del Corral, PhD, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/126-EC_X_Tesis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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