Urban Training for COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897298
• Other study ID #: PI11/01283
• Secondary ID: 147/2011
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: April 26, 2018
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2018
• Source: Barcelona Institute for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 admissions, exercise capacity, body composition, quality of life, and mental health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Urban training
Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	CAP Maresme	Mataró	Barcelona
Spain	CAP Maria Bernades	Viladecans	Barcelona

Sponsors (11)

Lead Sponsor	Collaborator
Judith Garcia-Aymerich	Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital de Mataró, Mataró, Hospital de Viladecans, Viladecans, Hospital del Mar, IDIAP Jordi Gol, Barcelona, Instituto de Salud Carlos III, Fondo de Investigación Sanitaria, Madrid, Sociedad Española de Neumología (SEPAR), Barcelona, Universitat Internacional de Catalunya, University Ramon Llull

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cognitive status	Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest	Baseline and 12months
Other	Changes in the Clinical PPAC	Changes between baseline and 12 months follow-up in phsyical activity measured with the Clinical visit "PROactive Physical Activity in COPD" instrument	Baseline and 12months
Primary	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	Baseline and 12 months follow-up
Secondary	COPD admissions to emergency-room or hospital		12 months follow-up
Secondary	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	Baseline and 12 months
Secondary	Change in body weight and composition	Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance	Baseline and 12 month
Secondary	Change in quality of life	Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ	Baseline and 12-m
Secondary	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	Baseline and 12 months