Rehabilitation
ProcedurePatients will undergo a respiratory rehabilitation program (24 exercise sessions of 90 minutes each, three times a week for 8 weeks and up to 9 therapeutic education workshops of 1 hour)
NCT Number: NCT06677268
COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time.
Among all COPD patients, 40% complain of sleep disorders. Polysomnography data showed a prolongation of sleep onset latency and a decrease in deep sleep, correlated with the severity of daytime hypoxemia. Conversely, poor sleep quality leads to an increase in dyspnea, altered quality of life and increased occurrence of COPD exacerbations.
Respiratory rehabilitation has demonstrated significant benefits on exercise capacity, dyspnea, COPD exacerbations and quality of life. To the investigators' knowledge, a few studies have investigated the relationship between physical activity and sleep quality using polysomnography in this population. Thus, the aim of the study is to evaluate the benefits of respiratory rehabilitation on sleep architecture in patients with COPD. Investigators' hypothesis is that a respiratory rehabilitation program would improve the quality of sleep measured by polysomnography. Therefore, patient with COPD and no exacerbation in the previous year will be randomly assigned to the interventional group who perform the rehabilitation program or to the control group who will not perform the program. The primary endpoint is the sleep quality estimated by total sleep time as measured by the mean of 2 independent polysomnography readings, at baseline and after the RR program in the interventional group and after 2 months of usual care in the control group.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Chu Amiens, Amiens, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will undergo a respiratory rehabilitation program (24 exercise sessions of 90 minutes each, three times a week for 8 weeks and up to 9 therapeutic education workshops of 1 hour)
Time frame: Baseline and end of respiratory rehabilitation (2 months)
measured by the average of the 2 independent polysomnography scorings
Time frame: From enrollment to the end of the follow-up at 11 weeks
Sleep onset latency (SOL) measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
subjective sleep quality measured by the questionnaire PSQI, Minimum score: 0 (best sleep quality), Maximum score: 21 (worst sleep quality).
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by Saint George's Hospital Respiratory Questionnaire (SGRQ), minimum score (0): indicates no impairment (best possible health status), maximum score (100): indicates severe impairment (worst possible health status).
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by Epworth Sleepiness Scale, minimum score of 0 (no daytime sleepiness), maximum score of 24 (severe daytime sleepiness).
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by the score modified Medical Research Council [mMRC], minimum score of 0 (least severe dyspnea), maximum score of 4 (most severe dyspnea).
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by COPD Assessment Test [CAT]
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by the HAD (Hospital Anxiety and Depression) scale, minimum score of 0 (no symptoms of anxiety or depression), maximum score of 21 (severe symptoms of anxiety or depression).
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured during an maximal exercise test
Time frame: From enrollment to the end of the follow-up at 11 weeks
measured by distance walked during 6 minutes.
Time frame: From enrollment to the end of the follow-up at 11 weeks
Wakefulness after sleep onset (WASO) measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
Sleep Efficiency measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
Number of awakenings measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
Micro-arousal index measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
N1 (%) measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
N2 (%) measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
N3 (%) measured by the average of the 2 independent polysomnography readings
Time frame: From enrollment to the end of the follow-up at 11 weeks
REM (%) (Rapid Eye Movement) measured by the average of the 2 independent polysomnography readings
Contact information is provided by the study sponsor or research team.
University Hospital, Rouen
Other
Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
Acronym: REARSOM/BPCO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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