NCT05210998

Respiratory Muscle Training Combined With Aerobic Exercise in Obstructive Sleep Apnea Syndrome

Completed NA Last updated 15 February 2024

What this trial tests

NA trial testing Gradual Aerobic exercise training AND Respiratory muscle training in Obstructive Sleep Apnea Syndrome in 36 participants. Completed in 30 July 2023.

Timeline

1 March 2022

Primary endpoint
1 March 2023

30 July 2023

Quick facts

Lead sponsor	Istanbul University - Cerrahpasa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	1 March 2022
Primary completion	1 March 2023
Estimated completion	30 July 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Gradual Aerobic exercise training AND Respiratory muscle training
• Gradual Aerobic exercise training

Conditions studied

• Obstructive Sleep Apnea Syndrome — all drugs for Obstructive Sleep Apnea Syndrome →

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 40 to 75, any sex, with Obstructive Sleep Apnea Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep Laboratory of the Department of Chest Diseases of the Istanbul University Istanbul Medical Faculty Hospital will be included. The cases will be divided into two groups with the randomization system and the education of both groups will continue for a total of 8 weeks. In the literature, it is stated that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct therapy to CPAP or oral devices. No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. For this reason, OSAS patients using regular CPAP were planned as two groups in the treatment part of this study. Control Group: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week.

Training Group: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.