Effects of Physical Activity Counseling After an Exacerbation in COPD

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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Behavioral: Physical activity

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Physical activity; Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
Placebo Comparator: Usual Care; 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.	Behavioral: Physical activity; Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in physical activity	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.	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven

Publications and helpful links

General Publications

• Hornikx M, Demeyer H, Camillo CA, Janssens W, Troosters T. The effects of a physical activity counseling program after an exacerbation in patients with Chronic Obstructive Pulmonary Disease: a randomized controlled pilot study. BMC Pulm Med. 2015 Nov 4;15:136. doi: 10.1186/s12890-015-0126-8.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; COPD; activity monitors
• Other Study ID Numbers: S55086; ML8991 (Other Identifier: University Hospital Leuven)