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Chronic Obstructive Pulmonary DiseaseNCT05565872

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

A study testing Urban training in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Urban training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
5 Oct 2022to 10 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Zona Básica de Salud Torrejón de Ardoz

    Torrejón de Ardoz, Madrid, 28850

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Urban training
Keywords
Exercise Therapy, Telerehabilitation, Exercise Tolerance, Physical Activity
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Respiratory Tract Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urban trainingBehavioural

    A community-based exercise intervention (Urban Training) by using public spaces and urban walkable trails, adapted to each patient needs and capabilities

Study groups in NCT05565872
Study groupRoleWhat they receive
Urban training Intervention + therapeutic education program with face-to-face supervisionExperimentalPatients will be advised to walk in the defined urban trails with face-to-face supervision
Receives: Behavioral: Urban training
Urban training Intervention + therapeutic education program with telematic supervisionActive comparatorPatients will be advised to walk in the defined urban trails with telematic supervision
Receives: Behavioral: Urban training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. 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

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

  2. 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

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

  3. 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.

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

  4. COPD exacerbations

    Number and duration of COPD exacerbations, and admissions to emergency-room or hospital

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start5 Oct 2022
  3. Primary completion20 Jun 2024
  4. Study completion10 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565872
Sponsor's protocol ID
22/126-EC_X_Tesis
Status last verified
Nov 2024
First submitted
27 Sep 2022
Last updated
25 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30166322

  • 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.

    PubMed 28250201

  • 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.

    PubMed 40866835

Questions about this trial

What is this clinical trial studying?

A study testing Urban training in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in exercise capacity (time frame: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565872, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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