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Urban Training for COPD Patients

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ClinicalTrials.gov Identifier: NCT01897298
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Instituto de Salud Carlos III, Fondo de Investigación Sanitaria, Madrid
Sociedad Española de Neumología (SEPAR), Barcelona
University Ramon Llull
Hospital Clinic of Barcelona
Hospital del Mar
Germans Trias i Pujol Hospital
Jordi Gol i Gurina Foundation
Hospital de Mataró, Mataró
Hospital de Viladecans, Viladecans
Universitat Internacional de Catalunya
Information provided by (Responsible Party):
Judith Garcia-Aymerich, Barcelona Institute for Global Health

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
Change in physical activity [ Time Frame: Baseline and 12 months follow-up ]
Change in physical activity between baseline and 12 months follow-up, as defined by average steps per day measured with an activity monitor
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
  • COPD admissions to emergency-room or hospital [ Time Frame: 12 months follow-up ]
  • Change in exercise capacity, as measured with 6-min walking distance [ Time Frame: Baseline and 12 months ]
    Change in exercise capacity between baseline and 12 months, as measured with 6-min walking distance
  • Change in body weight and composition [ Time Frame: Baseline and 12 month ]
    Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance
  • Change in quality of life [ Time Frame: Baseline and 12-m ]
    Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ
  • Change in anxiety and depression symptoms [ Time Frame: Baseline and 12 months ]
    Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2015)
  • Changes in cognitive status [ Time Frame: Baseline and 12months ]
    Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest
  • Changes in the Clinical PPAC [ Time Frame: Baseline and 12months ]
    Changes between baseline and 12 months follow-up in phsyical activity measured with the Clinical visit "PROactive Physical Activity in COPD" instrument
Original Other Pre-specified Outcome Measures
 (submitted: July 9, 2013)
Changes in cognitive status [ Time Frame: Baseline and 12months ]
Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest
 
Descriptive Information
Brief Title  ICMJE Urban Training for COPD Patients
Official Title  ICMJE Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial
Brief 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 admissions, exercise capacity, body composition, quality of life, and mental health.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE Behavioral: Urban training
Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
Study Arms  ICMJE
  • Experimental: Urban training Intervention
    Patients will be advised to walk in the defined urban trails.
    Intervention: Behavioral: Urban training
  • No Intervention: Usual care
    Patients will continue their usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2016)
412
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2013)
600
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01897298
Other Study ID Numbers  ICMJE PI11/01283
147/2011 ( Other Grant/Funding Number: SEPAR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Judith Garcia-Aymerich, Barcelona Institute for Global Health
Study Sponsor  ICMJE Judith Garcia-Aymerich
Collaborators  ICMJE
  • Instituto de Salud Carlos III, Fondo de Investigación Sanitaria, Madrid
  • Sociedad Española de Neumología (SEPAR), Barcelona
  • University Ramon Llull
  • Hospital Clinic of Barcelona
  • Hospital del Mar
  • Germans Trias i Pujol Hospital
  • Jordi Gol i Gurina Foundation
  • Hospital de Mataró, Mataró
  • Hospital de Viladecans, Viladecans
  • Universitat Internacional de Catalunya
Investigators  ICMJE
Principal Investigator: Judith Garcia-Aymerich, MD PhD Centre for Research in Environmental Epidemiology (CREAL)
PRS Account Barcelona Institute for Global Health
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP