Physical Activity Enhancement Using Pedometers in COPD

Not Applicable

• Conditions: COPD
• Interventions: Device: pedometers

• Registration Number: NCT01739751
• Lead Sponsor: University of Chile

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Status Verified: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04
• Primary Completion: 2013-03
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedometers	pedometers	With a program of physical activity enhancement using pedometers as a feedback

Primary Outcome Measures

Name	Time	Method
effect in average steps walked daily	3 months	Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation

Secondary Outcome Measures

Name	Time	Method
six minute walking distance	3 months	Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation
score in the Saint George Respiratory Questionnaire	3 months	Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation
Score of the COPD Assessment Test (CAT)	3 months	Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile