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

University of Zurich74 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

COPD

Interventions

InterventionBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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