Clinical trial NCT05565872: Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lung Diseases, Obstructive
Respiratory Tract Diseases
Keywords: Exercise Therapy
Telerehabilitation
Exercise Tolerance
Physical Activity
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
name: Gerencia de Atención Primaria, Madrid
First posted: 2022-10-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in exercise capacity
timeFrame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Secondary outcomes:
measure: Change in physical activity
timeFrame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
measure: Change in quality of life
timeFrame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
measure: Change in anxiety and depression symptoms
timeFrame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
measure: COPD exacerbations
timeFrame: Post-intervention (up to 13 weeks), 6 months and 12 months
Other outcomes:
measure: The effect of an attendance at an urban training program on changes in self-efficacy
timeFrame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
measure: Adherence to treatment
timeFrame: Post-intervention (up to 13 weeks), 6 months and 12 months
Locations:
city: Torrejón De Ardoz
country: Spain
facility: Zona Básica de Salud Torrejón de Ardoz
state: Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Tamara del Corral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.