Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

Study Overview
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Brief Summary
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Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

Detailed Description
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Daily physical activity (PA) is a predictor of survival in the general population and has become a significant outcome measure in patients with COPD. Recent studies have demonstrated an independent association between PA, hospitalizations and mortality. Increased PA has significant benefits for patients with COPD. In most studies PA has only been assessed at one time point. Little is known about longitudinal changes in PA and data on determinants of changes in PA are scant. Moreover, information on best approaches to enhance PA in a population with decreasing PA is missing. To evaluate the long-term effect of a coaching program which is aimed at helping patients with severe COPD (FEV1<50%) to enhance their level of daily physical activity, in addition to usual care. Furthermore, this study aims to evaluate mechanisms that are responsible for changes of physical activity over time such as sociodemographic factors, lung function, comorbidities, vascular function, exacerbations, and medication.

Official Title
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Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Age ≥ 40 years Severe COPD (FEV1<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org) Exclusion Criteria: Physical or intellectual impairment precluding informed consent or protocol adherence Acute or recent (within the last 6 weeks) exacerbation of COPD Attending a pulmonary rehabilitation program within the last 6 months Pregnant patients

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized 1:1 to one of the two groups: conventional care group or intervention group. No minimization procedures are used.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient during 3 months. | Behavioral: Intervention<br>* Patients allocated to the intervention group receive a pedometer. They are encouraged to be more active by using the pedometer to measure the number of steps walked daily. An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient. Monthly telephone calls are indicated to encourage compliance with the protocol and motivate patients to enhance their level of activity. The coached program ends after three months but patients keep their pedometer and are encouraged to sustain an increased level of daily physical activity for additional 9 months (end of study).<br>|
| No Intervention: Control<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls. | At visits, the number of steps per day will be assessed by a multisensory band (SenseWear Pro™; Bodymedia Inc., Pittsburgh, PA, USA) which will be worn on the upper left arm for 7 consecutive days. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of endothelial function by flow-mediated dilatation | Flow-mediated dilatation measurements will be performed by ultrasonography of the brachial artery with a high-frequency (10.0-MHz) ultrasound-scanning probe proximal to the antecubital fossa. Flow mediated dilatation will be assessed by percent of baseline Diameter. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Physical activity, Endothelial function