Physical Activity Enhancement Using Pedometers in COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Device: pedometers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients without feedback of a pedometers, followed for 3 months | |
| Experimental: Pedometers<br>With a program of physical activity enhancement using pedometers as a feedback | Device: pedometers<br>* portable device that estimate the number of steps walked daily<br>* Other names: PD 724;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect in average steps walked daily | Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Physical activity, Pedometers, steps, non pharmacological treatment, rehabilitation, exercise