Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive, Respiratory Tract Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Urban training
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise Therapy, Telerehabilitation, Exercise Tolerance, Physical Activity
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)
Sites / Locations
- Zona Básica de Salud Torrejón de ArdozRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Urban training Intervention + therapeutic education program with face-to-face supervision
Urban training Intervention + therapeutic education program with telematic supervision
Arm Description
Patients will be advised to walk in the defined urban trails with face-to-face supervision
Patients will be advised to walk in the defined urban trails with telematic supervision
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
COPD exacerbations
Number and duration of COPD exacerbations, and admissions to emergency-room or hospital
Full Information
NCT ID
NCT05565872
First Posted
September 27, 2022
Last Updated
October 4, 2022
Sponsor
Universidad Complutense de Madrid
Collaborators
Sociedad Española de Neumología y Cirugía Torácica, Gerencia de Atención Primaria, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05565872
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Sociedad Española de Neumología y Cirugía Torácica, Gerencia de Atención Primaria, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive, Respiratory Tract Diseases
Keywords
Exercise Therapy, Telerehabilitation, Exercise Tolerance, Physical Activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urban training Intervention + therapeutic education program with face-to-face supervision
Arm Type
Experimental
Arm Description
Patients will be advised to walk in the defined urban trails with face-to-face supervision
Arm Title
Urban training Intervention + therapeutic education program with telematic supervision
Arm Type
Active Comparator
Arm Description
Patients will be advised to walk in the defined urban trails with telematic supervision
Intervention Type
Behavioral
Intervention Name(s)
Urban training
Intervention Description
A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities
Primary Outcome Measure Information:
Title
Change in exercise capacity
Description
Change in exercise capacity between baseline, up to 13 weeks, 6 months and 12 months, as measured by 6-min walking distance
Time Frame
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
Change in physical activity between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured during 1 week by accelerometer
Time Frame
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Title
Change in quality of life
Description
Change in quality of life between baseline, up to 13 weeks, 6 months and 12 months follow-up, as measured by COPD Assessment Test
Time Frame
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Title
Change in anxiety and depression symptoms
Description
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.
Time Frame
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Title
COPD exacerbations
Description
Number and duration of COPD exacerbations, and admissions to emergency-room or hospital
Time Frame
Post-intervention (up to 13 weeks), 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
The effect of an attendance at an urban training program on changes in self-efficacy
Description
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.
Time Frame
Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Title
Adherence to treatment
Description
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)
Time Frame
Post-intervention (up to 13 weeks), 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara del Corral, PhD
Phone
(0034) 91 394 1517
Email
tamdelco@ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara del Corral, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zona Básica de Salud Torrejón de Ardoz
City
Torrejón De Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Sacristán Galisteo, MsC
Email
cristinasacristangalisteo@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30166322
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.
Results Reference
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PubMed Identifier
28250201
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.
Results Reference
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Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD
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