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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-05-20

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.

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will be randomized 1:1 to one of the two groups: conventional care group or intervention group. No minimization procedures are used.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type BEHAVIORAL

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).

Control

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

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).

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No