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OpenTrials
Completed

NCT Number: NCT01897298

Urban Training for COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urban training

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. COPD admissions to emergency-room or hospital

    Time frame: 12 months follow-up

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. Changes in cognitive status

    Time frame: Baseline and 12months

    Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest

  2. 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

Sponsors and collaborators

Lead sponsor

Judith Garcia-Aymerich

Other

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Germans Trias i Pujol Hospital
  • Hospital Clinic of Barcelona
  • Hospital de Mataró
  • Hospital de Viladecans
  • Hospital del Mar
  • Instituto de Salud Carlos III
  • Sociedad Española de Neumología (SEPAR), Barcelona
  • Universitat Internacional de Catalunya
  • University Ramon Llull

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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