COPDNCT03314558
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?
An observational study of COPD, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- pulmonary rehabilitation
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2017to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients physically able to follow a pulmonary rehabilitation program
Who may be able to join
- COPD patients
- able to walk and cycle
Who cannot join
- Shift work
- orthopedic diseases of limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?
The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.
Read the 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.
- Conditions
- COPD
- Being tested
- pulmonary rehabilitation
- Keywords
- COPD, pulmonary rehabilitation, insomnia, sleep quality, physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients
| Study group | Role | What they receive |
|---|---|---|
| COPD patients following a pulmonary rehabilitation program | COPD patients following a pulmonary rehabilitation program Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep efficiency
sleep efficiency assessed by actigraphy
Measured: 3 +/- 2 months
Secondary outcomes (1)
steps
number of steps walked daily assessed by actigraphy
Measured: 3 +/- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start15 Nov 2017
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314558
- Sponsor's protocol ID
- RR2017
- Status last verified
- Jan 2023
- First submitted
- 16 Oct 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?
- ClinicalTrials.gov ID
- NCT03314558
- Acronym / sponsor ID
- RR2017
- Conditions
- COPD
- Keywords
- COPD, pulmonary rehabilitation, insomnia, sleep quality, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients following a pulmonary rehabilitation program | – | Other: pulmonary rehabilitationCOPD patients following a pulmonary rehabilitation program |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients physically able to follow a pulmonary rehabilitation program
Key inclusion criteria (2 listed)
- COPD patients
- able to walk and cycle
Key exclusion criteria (2 listed)
- Shift work
- orthopedic diseases of limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitationa pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients | Other | COPD patients following a pulmonary rehabilitation program |
Primary outcome
sleep efficiency
Time frame: 3 +/- 2 months
sleep efficiency assessed by actigraphy
1 secondary outcome
steps
Time frame: 3 +/- 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep efficiency (time frame: 3 +/- 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.