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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Behavioral: Intervention

• Registration Number: NCT03114241
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-05-02
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient during 3 months.

Primary Outcome Measures

Name	Time	Method
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.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of endothelial function by flow-mediated dilatation	12 months	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.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland