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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gradual Aerobic exercise training AND Respiratory muscle training
Gradual Aerobic exercise training
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Sleep Apnea , Respiratory Muscle Training, Aerobic Exercise

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Being diagnosed with Severe Obstructive Sleep Apnea 2. Being over 40 years old 3. Using CPAP 4. Not to be included in any exercise and diet program throughout the study

Exclusion Criteria:

  1. Unstable angina pectoris,
  2. Body Mass Index (BMI)>35 kg/m2
  3. Chronic Lung Disease
  4. Neurological or musculoskeletal problems that prevent him from exercising
  5. Congestive heart failure
  6. Unstable cardiovascular conditions
  7. Unstable metabolic conditions

Sites / Locations

  • Istanbul University Istanbul Medical FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

grup 1:

grup 2:

Arm Description

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

Aerobic Exercise Group: Gradual Aerobic exercise training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Respiratory Muscle Strength Assessment.
In the evaluation of respiratory muscle strength, mouth pressure measurement method will be used in accordance with ATS/ERS criteria.

Full Information

First Posted
December 4, 2021
Last Updated
July 19, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05210998
Brief Title
Respiratory Muscle Training Combined With Aerobic Exercise in Obstructive Sleep Apnea Syndrome
Official Title
Investigation of the Effects of Respiratory Muscle Training Combined With Aerobic Exercise in Persons With Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Combined Exercises Grup: 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. Aerobic Exercises Grup: 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 Obstructive Sleep Apnea Syndrome (OSAS) is a syndrome with a highly complex pathophysiology characterized by repetitive complete or partial upper airway occlusions during sleep. As a result of collapse in the pharyngeal airways during sleep, air flow to the lungs decreases partially (hypopnea) or completely (apnea), hypoxia and hypercapnia develop, and the congestion ends with the end of sleep. The repetition of these situations that develop during sleep stimulates the sympathetic nervous system and causes changes in blood pressure.Excessive daytime sleepiness and neurocognitive disorders can be observed as a result of sleep disruptions and hypoxia that develop with multiple stimuli .It has been reported that there is a continuous increase in the prevalence of OSAS. The incidence of OSAS in the general adult population varies between 9-38%, with a higher incidence in males. Due to obesity, its prevalence is increasing at an alarming rate, especially in middle and high-income countries . OSAS causes potentially serious health consequences such as impaired quality of life, emotional impairment, neurocognitive impairment, permanent brain damage, cardiovascular morbidity, and sudden death during sleep. OSAS has a very complex pathophysiology and the roles of influencing factors are also variable among individuals. In the physiopathology of upper airway obstruction, factors such as anatomical and mechanical factors, impaired contractile function of upper airway muscles, respiratory control instability come to the fore . One of the mechanisms that cause altered neuromechanical responses in OSAS is the deterioration of the contractile function of the upper airway muscles. In these patients, the upper respiratory tract muscles work under hypoxic conditions and as a result, a modification in the muscle fiber structure develops. In this modification, muscle fibers change from type I fibers that are resistant to fatigue to type II muscle fibers that increase strength but are not resistant to fatigue. As a result, the contractility of the muscle is preserved, but the fatigue increases. With this modification in the muscle fiber, inflammation may occur in the muscle working under increased load, with muscle damage that impairs the contractility of the muscle. Muscle dysfunction may develop as a result of these events . During sleep, there is a decrease in lung volume and upper airway dilator muscle tone. Therefore, upper and lower airway muscle function is relatively reduced during sleep and may increase airway obstruction. It is thought that increasing upper airway dilator muscle activity and increasing lung volume are effective in maintaining airway patency. Coordinated contraction of the upper airway dilator muscles (eg genioglossus) and inspiratory pump muscles (eg diaphragm) is required for breathing to continue with an open airway. Inspiratory muscle weakness increases susceptibility to hypoventilation during sleep . Treatment methods of OSAS include conservative (Continuous Positive Airway Pressure (CPAP) device and intraoral device applications) and surgical interventions. CPAP therapy, which is the most effective method available in OSAS, has been shown to improve sleepiness, hypertension and many cardiovascular indices seen in patients . CPAP is considered the first choice in the treatment of especially moderate or severe OSAS cases, but it is costly and patient compliance is an important condition that affects treatment success. It is known that respiratory muscle training increases respiratory muscle strength in people with COPD and neuromuscular diseases . It has been reported that inspiratory muscle training in OSAS patients improves OSAS severity, daytime sleepiness and sleep quality, decreases the severity and frequency of snoring, improves respiratory muscle strength, and can reduce the cost of CPAP treatment by increasing its use in rehabilitation programs. However, it has been shown that training applied to the upper respiratory tract with the didgeridoo instrument in people with snoring and OSAS reduces daytime sleepiness, apnea-hypopnea index, and upper airway collapse. Strengthening both inspiratory and expiratory muscles seems reasonable given that weakness of the upper airway and inspiratory muscles in these patients affects sleep-related outcome measures. In addition, it is stated in the literature that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct to CPAP or oral devices . It is known that most of the patients with OSAS also have low exercise capacity. OSAS severity is associated with worsening exercise tolerance. In the treatment of OSAS patients, exercise training in addition to CPAP therapy has received increasing attention in recent years . It has been shown that regular exercise training applied in patients with OSAS reduces AHI, body weight and body mass index, improves aerobic capacity and quality of life . In a recent meta-analysis, aerobic exercise training has been reported to effectively improve quality of life, daytime sleepiness, and sleep quality . No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. The aim of this study is to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Sleep Apnea , Respiratory Muscle Training, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
grup 1:
Arm Type
Active Comparator
Arm Description
Combined Exercise Group: Gradual aerobic exercise training AND Respiratory muscle training
Arm Title
grup 2:
Arm Type
Active Comparator
Arm Description
Aerobic Exercise Group: Gradual Aerobic exercise training
Intervention Type
Other
Intervention Name(s)
Gradual Aerobic exercise training AND Respiratory muscle training
Intervention Description
Combined Exercise Group
Intervention Type
Other
Intervention Name(s)
Gradual Aerobic exercise training
Intervention Description
Aerobic exercise Group
Primary Outcome Measure Information:
Title
Polysomnography (PSG)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Respiratory Muscle Strength Assessment.
Description
In the evaluation of respiratory muscle strength, mouth pressure measurement method will be used in accordance with ATS/ERS criteria.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goksen Kuran Aslan, Assoc. Prof.
Phone
902128663700
Email
goksen.kuranaslan@iuc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Esen Kiyan, Professor
Phone
902128663700
Email
esenkiyan@gmail.com
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Abanoz, MsC

12. IPD Sharing Statement

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

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