- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314558
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?
Study Overview
Detailed Description
COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation between altered sleep quality and low activity levels have been shown in this population. In primary insomnia, it is well established that physical activity has a positive impact on sleep quality.
The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1000
- CHU Saint Pierre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- COPD patients
- able to walk and cycle
Exclusion Criteria:
- Shift work
- orthopedic diseases of limbs
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COPD patients following a pulmonary rehabilitation program
|
a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep efficiency
Time Frame: 3 +/- 2 months
|
sleep efficiency assessed by actigraphy
|
3 +/- 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
steps
Time Frame: 3 +/- 2 months
|
number of steps walked daily assessed by actigraphy
|
3 +/- 2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RR2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.