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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565872
• Other study ID #: 22/126-EC_X_Tesis
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: April 2024
• Source: Universidad Complutense de Madrid
• Contact: Tamara del Corral, PhD
• Phone: (0034) 91 394 1517
• Email: tamdelco[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Zona Básica de Salud Torrejón de Ardoz	Torrejón De Ardoz	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Gerencia de Atención Primaria, Madrid, Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of an attendance at an urban training program on changes in self-efficacy	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
Other	Adherence to treatment	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
Primary	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	Change in physical activity	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
Secondary	Change in quality of life	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
Secondary	Change in anxiety and depression symptoms	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
Secondary	COPD exacerbations	Number and duration of COPD exacerbations, and admissions to emergency-room or hospital	Post-intervention (up to 13 weeks), 6 months and 12 months