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

NCT05565872 | Completed

• 1 other identifier: 22/126-EC_X_Tesis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Exercise Therapy; Telerehabilitation; Exercise Tolerance; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity

  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 Outcomes (4)

• Change in physical activity

  Baseline, post-intervention (up to 13 weeks), 6 months and 12 months

• Change in quality of life

  Baseline, post-intervention (up to 13 weeks), 6 months and 12 months

• Change in anxiety and depression symptoms

  Baseline, post-intervention (up to 13 weeks), 6 months and 12 months

• COPD exacerbations

  Post-intervention (up to 13 weeks), 6 months and 12 months

Other Outcomes (2)

• 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

• Adherence to treatment

  Post-intervention (up to 13 weeks), 6 months and 12 months

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Urban training

Urban training Intervention + therapeutic education program with telematic supervision

ACTIVE COMPARATOR

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

Behavioral: Urban training

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator
• Gerencia de Atención Primaria, Madrid: collaborator

Study Sites (1)

Zona Básica de Salud Torrejón de Ardoz

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Related Publications (2)

• Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Benet M, Borrell E, Celorrio N, Delgado A, Jane C, Marin A, Martin-Cantera C, Monteagudo M, Montella N, Munoz L, Ortega P, Rodriguez DA, Rodriguez-Roisin R, Simonet P, Toran-Monserrat P, Torrent-Pallicer J, Vall-Casas P, Vilaro J, Garcia-Aymerich J. Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial. Eur Respir J. 2018 Oct 18;52(4):1800063. doi: 10.1183/13993003.00063-2018. Print 2018 Oct.

  PMID: 30166322 BACKGROUND

• Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Borrell E, Dadvand P, Foraster M, Marin A, Monteagudo M, Rodriguez-Roisin R, Vall-Casas P, Vilaro J, Garcia-Aymerich J; Urban Training Study Group. Socio-environmental correlates of physical activity in patients with chronic obstructive pulmonary disease (COPD). Thorax. 2017 Sep;72(9):796-802. doi: 10.1136/thoraxjnl-2016-209209. Epub 2017 Mar 1.

  PMID: 28250201 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Respiratory Tract Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tamara del Corral, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: October 5, 2022
• Primary Completion: June 20, 2024
• Study Completion: July 10, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)