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Chronic Obstructive Pulmonary Disease (COPD)NCT01897298

Urban Training for COPD Patients

A study testing Urban training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Judith Garcia-Aymerich at 5 sites 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 training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD… Read more about this study

Who is it for?
Ages 45 to 130 years
What is being tested?
Urban training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
5 sitesSpain
Study dates
Jul 2013to Mar 2016
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 45 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age > 45 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 4 weeks without antibiotics or oral corticosteroids.

Who cannot join

  • living >6 months/year outside of the included municipalities,
  • living to a distance higher than 500 meters to any of the urban trails used for the study,
  • mental disability according to the Mini Mental State Examination in its validated Spanish version
  • comorbidity that could interfere with study tests (e.g., lower limb amputation)
  • severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic

    Barcelona, 08036

  • CAP Maresme

    Mataró, Barcelona, 08303

  • CAP Maria Bernades

    Viladecans, Barcelona, 08840

Other trials in Spain

About this study

Official title: Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial

This project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD admissions, exercise capacity, body composition, quality of life, and mental health.

Being tested
Urban training
Keywords
chronic obstructive pulmonary disease (COPD), urban training, physical activity, active aging
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

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

  • Urban trainingBehavioural

    Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.

Study groups in NCT01897298
Study groupRoleWhat they receive
Urban training InterventionExperimentalPatients will be advised to walk in the defined urban trails.
Receives: Behavioral: Urban training
Usual careNo interventionPatients will continue their usual care

What is being measured

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

  1. Change in physical activity

    Change in physical activity between baseline and 12 months follow-up, as defined by average steps per day measured with an activity monitor

    Measured: Baseline and 12 months follow-up

Secondary outcomes (5)

  1. COPD admissions to emergency-room or hospital

    Measured: 12 months follow-up

  2. Change in exercise capacity, as measured with 6-min walking distance

    Change in exercise capacity between baseline and 12 months, as measured with 6-min walking distance

    Measured: Baseline and 12 months

  3. Change in body weight and composition

    Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance

    Measured: Baseline and 12 month

  4. Change in quality of life

    Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ

    Measured: Baseline and 12-m

  5. Change in anxiety and depression symptoms

    Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale

    Measured: Baseline 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 posted11 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionFeb 2016
  4. Study completionMar 2016

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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897298
Sponsor's protocol ID
PI11/01283
Other IDs
147/2011
Status last verified
Apr 2018
First submitted
3 Jul 2013
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Delgado-Ortiz L, Arbillaga-Etxarri A, Rodriguez-Chiaradia DA, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Rodriguez-Roisin R, Garcia-Aymerich J. Physical activity and cardiac autonomic dysfunction in patients with chronic obstructive pulmonary disease: A cross-sectional analysis. Ann Phys Rehabil Med. 2022 May;65(3):101501. doi: 10.1016/j.rehab.2021.101501. Epub 2021 Nov 22.

    PubMed 33662597

  • Koreny M, Demeyer H, Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Balcells E, Borrell E, Marin A, Rodriguez Chiaradia DA, Vall-Casas P, Vilaro J, Rodriguez-Roisin R, Garcia-Aymerich J. Determinants of study completion and response to a 12-month behavioral physical activity intervention in chronic obstructive pulmonary disease: A cohort study. PLoS One. 2019 May 20;14(5):e0217157. doi: 10.1371/journal.pone.0217157. eCollection 2019.

    PubMed 31107900

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Urban training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Judith Garcia-Aymerich at 5 sites 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 5 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 physical activity (time frame: Baseline and 12 months follow-up). 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 NCT01897298, which also lists 4 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 27 Apr 2018.

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