Effects of Physical Activity Counseling After an Exacerbation in COPD

Not Applicable

Completed

• Conditions: COPD Exacerbation
• Interventions: Behavioral: Physical activity

• Registration Number: NCT02223962
• Lead Sponsor: KU Leuven

Brief Summary

Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

Detailed Description

After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.

Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-09-04
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Signed Informed Consent
• Chronic Obstructive Lung Disease (Tiff<70%)
• Hospitalized because of exacerbation
• Capable of working with electronic devices

Exclusion Criteria

• Orthopedic/Neurologic problems making it difficult to be active
• Participation in a rehabilitation program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Physical activity	During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.
Physical activity	Physical activity	The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.

Primary Outcome Measures

Name	Time	Method
Improvement in physical activity	1 month	The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.

Secondary Outcome Measures

Name	Time	Method
Improvement in functional exercise capacity	1 month	Functional exercise capacity was measured by the six minutes walking distance test (6MWD; meter). This measurement was performed at baseline and after 1 month.

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Belgium