This trial is active, not recruiting.

Condition copd
Treatment pedometers
Sponsor University of Chile
Collaborator Comisión Nacional de Investigación Científica y Tecnológica
Start date January 2011
End date March 2013
Trial size 90 participants
Trial identifier NCT01739751, SA10i20022


Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(No Intervention)
Patients without feedback of a pedometers, followed for 3 months
With a program of physical activity enhancement using pedometers as a feedback
pedometers PD 724
portable device that estimate the number of steps walked daily

Primary Outcomes

effect in average steps walked daily
time frame: 3 months

Secondary Outcomes

six minute walking distance
time frame: 3 months
score in the Saint George Respiratory Questionnaire
time frame: 3 months
Score of the COPD Assessment Test (CAT)
time frame: 3 months

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - COPD diagnosis according to GOLD guidelines - Pack year Index equal or more than 10 - smoking suspended > 2 months - older than 40 years old, Exclusion Criteria: - any chronic condition that does not allow walking - participation in a rehabilitation program - Acute exacerbation in the last two months

Additional Information

Official title Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease
Principal investigator Laura Mendoza, MD
Description Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by University of Chile.