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| Name | Class |
|---|---|
| Sociedad Española de Neumología y Cirugía Torácica | OTHER |
| Gerencia de Atención Primaria, Madrid | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adherence to treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara del Corral, PhD | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zona Básica de Salud Torrejón de Ardoz | Torrejón de Ardoz | Madrid | 28850 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30166322 | Background | 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. | |
| 28250201 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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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 | 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 | Number and duration of COPD exacerbations, and admissions to emergency-room or hospital | 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 |
| 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. |
| 40866835 | Derived | Sacristan-Galisteo C, Del Corral T, Gomez-Pesquera C, Rodriguez-Barrientos R, Fontana-Campos M, Arbillaga-Etxarri A, Lopez-de-Uralde-Villanueva I, Rodriguez-Gonzalez-Moro JM, Martin-Casas P. Long-term effects of face-to-face supervision versus telephone supervision during a community-based pulmonary rehabilitation programme in people with COPD using minimal equipment: a randomized controlled trial. BMC Prim Care. 2025 Aug 27;26(1):268. doi: 10.1186/s12875-025-02962-3. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |