NCT03314558

Brief Summary

The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

4.8 years

First QC Date

October 16, 2017

Last Update Submit

January 16, 2023

Conditions

COPD

Keywords

COPDpulmonary rehabilitationinsomniasleep qualityphysical activity

Outcome Measures

Primary Outcomes (1)

  • sleep efficiency

    sleep efficiency assessed by actigraphy

    3 +/- 2 months

Secondary Outcomes (1)

  • steps

    3 +/- 2 months

Study Arms (1)

COPD patients following a pulmonary rehabilitation program

COPD patients following a pulmonary rehabilitation program

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitationOTHER

a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients

COPD patients following a pulmonary rehabilitation program

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients physically able to follow a pulmonary rehabilitation program

You may qualify if:

  • COPD patients
  • able to walk and cycle

You may not qualify if:

  • Shift work
  • orthopedic diseases of limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu Saint Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

November 15, 2017

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)