Effects of Physical Activity Counseling After an Exacerbation in COPD

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223962
• Other study ID #: S55086
• Secondary ID: ML8991
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: April 30, 2015
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No