Has Pulmonary Rehabilitation a Positive Impact on Sleep Q... | NCT03314558

Studies
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?

NCT03314558

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Last Update Posted

Jan 18, 2023Actual

Enrollment

31Actual

Phase

Not provided

Conditions

COPD

Interventions

pulmonary rehabilitation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Aug 31, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2023

Last Update Posted Date

Jan 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Bruyneel, Chef de Clinique, Centre Hospitalier Universitaire Saint PierrePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Saint PierreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD patients following a pulmonary rehabilitation program		COPD patients following a pulmonary rehabilitation program	Other: pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulmonary rehabilitation	Other	a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients	COPD patients following a pulmonary rehabilitation program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep efficiency	sleep efficiency assessed by actigraphy	3 +/- 2 months

Secondary Outcomes

Measure	Description	Time Frame
steps	number of steps walked daily assessed by actigraphy	3 +/- 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD patients
able to walk and cycle

Exclusion Criteria:

Shift work
orthopedic diseases of limbs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

COPD patients physically able to follow a pulmonary rehabilitation program

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHu Saint Pierre		Brussels		1000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D007319	Sleep Initiation and Maintenance Disorders
D009043	Motor Activity

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided