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

NCT05210998 | Completed

• 1 other identifier: Obstructive Sleep Apnea
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Sleep Apnea , Respiratory Muscle Training, Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• Polysomnography (PSG)

  Polysomnography is the gold standard diagnostic test for the diagnosis of adult patients with suspected OSAS based on a comprehensive sleep assessment. It is also used to evaluate the severity of OSAS and the effectiveness of treatment.Patients over the age of 40, who were diagnosed with severe (AHI: 30 and above) Obstructive Sleep Apnea Syndrome by a Chest Diseases Specialist by polysomnography in the Sleep Laboratory of the Chest Diseases Department of the Istanbul University Istanbul Medical Faculty Hospital, will be included in the study. Polysomnography is routinely performed in the Sleep Laboratory in the diagnosis and follow-up of patients with OSAS.

  8 weeks

Secondary Outcomes (1)

• Respiratory Muscle Strength Assessment.

  8 weeks

Study Arms (2)

grup 1:

ACTIVE COMPARATOR

Combined Exercise Group: Gradual aerobic exercise training AND Respiratory muscle training

Other: Gradual Aerobic exercise training AND Respiratory muscle training

grup 2:

ACTIVE COMPARATOR

Aerobic Exercise Group: Gradual Aerobic exercise training

Other: Gradual Aerobic exercise training

Interventions

Gradual Aerobic exercise training AND Respiratory muscle training OTHER

Combined Exercise Group

grup 1:

Gradual Aerobic exercise training OTHER

Aerobic exercise Group

grup 2:

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with Severe Obstructive Sleep Apnea
• Being over 40 years old
• Using CPAP
• Not to be included in any exercise and diet program throughout the study

You may not qualify if:

• Unstable angina pectoris,
• Body Mass Index (BMI)\>35 kg/m2
• Chronic Lung Disease
• Neurological or musculoskeletal problems that prevent him from exercising
• Psychiatric disorder (eg, Bipolar disorder, schizophrenia)
• Unstable cardiovascular conditions
• Unstable metabolic conditions

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (24)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Physioterapist

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: January 27, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 30, 2023
• Last Updated: February 15, 2024

Record last verified: 2023-06

Locations

TU (1)