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Clinical Trials/NCT02223962
NCT02223962CompletedNot Applicable

The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.

KU Leuven1 site in 1 country30 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
KU Leuven
Enrollment
30
Locations
1
Primary Endpoint
Improvement in physical activity

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Physical activity

Experimental

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.

Intervention: Physical activity (Behavioral)

Usual Care

Placebo Comparator

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.

Intervention: Physical activity (Behavioral)

Outcomes

Primary Outcomes

Improvement in physical activity

Time Frame: 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 Outcomes

  • Improvement in functional exercise capacity(1 month)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marc Decramer

Prof. Dr.

KU Leuven

Study Sites (1)

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