Respiratory Rehabilitation and Sleep Quality in COPD Patients

NCT ID: NCT06677268

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2028-02-29

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

interventional

Patient in this arm will perform a 2-months respiratory rehabilitation program

Group Type: EXPERIMENTAL

rehabilitation

Intervention Type: PROCEDURE

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 of the patient\'s choice)

control

patient in the control group will have standard care without respiratory rehabilitation program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rehabilitation

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 of the patient\'s choice)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ age 50
• COPD defined according to the GOLD 2022 criteria, clinically stable (without exacerbation for at least 4 weeks), with indication for respiratory rehabilitation
• Absence of respiratory rehabilitation in the past 12 months
• Patient affiliated to the social security system
• For women of childbearing potential who have been on effective contraception (estrogen-progestogen or intrauterine device or tubal ligation) for 1 month.
• For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
• Patient who has read and understood the information letter and signed the consent form

Exclusion Criteria

• BMI≥ 30 kg/m2
• Previously documented OSA (AHI > 10/h)
• Patient with a CPAP or NIV
• Patient on systemic corticosteroid therapy
• Patient on centrally acting therapy (benzodiazepine or opiate)
• Patient with an occurrence of severe COPD exacerbation
• Patient with other associated chronic respiratory insufficiency
• Patient with active cancer
• Patient with neuromuscular disease
• Patient with an osteoarticular disability or traumatic or neurological sequelae preventing participation in the respiratory rehabilitation program
• Psychiatric, cognitive or linguistic disorders with inability to understand to follow the protocol
• Patient with a contraindication to respiratory rehabilitation or any pathology preventing physical rehabilitation
• Patient with a cardiovascular contraindication to respiratory rehabilitation
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial safeguard, guardianship or curatorship
• Person subject to a legal protection measure
• Pregnant or parturient or breastfeeding woman

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Marie-Anne Melone, MD, PhD

Role: CONTACT

marieanne.melone@chu-rouen.fr

(+33) 0232888265

Other Identifiers

2022/0347/HP

Identifier Type: -

Identifier Source: org_study_id