Effects of High-intensity Interval Training and Aerobic Exercise on Obstructive Sleep Apnea.

Sponsor

Inonu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05416398

Collaborator

(none)

Enrollment

Location

Arms

18.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Introduction: Obstructive sleep apnea syndrome (OSAS) is a condition characterized by recurrent episodes of partial or complete obstruction of the upper airway (URI) during sleep.

Objective: It was designed to compare the effects of aerobic and high-intensity interval training training on exercise capacity, fatigue, cognitive status, physical and disease-specific parameters in individuals with obstructive sleep apnea syndrome.

Materials and Methods: It was designed as a randomized controlled experimental model. Patients between the ages of 18-55 who were diagnosed with OSAS by polysomnography by a specialist physician, and those with moderate (AHI: 16-30) and severe (AHI> 30) OSAS will be included. After the patients were selected from the relevant population with the improbable random sampling method, the patients who accepted to participate in the study and met the inclusion criteria will be assigned to one of the aerobic exercise group, high-intensity interval training training group or control group with the closed-envelope method. Evaluations will be evaluated for each group before the first session of the exercise program and one day after the last session after they have completed the 8-week exercise program. Evaluation parameters; 6-minute walk test, fatigue severity scale, stroop test, skinfold, tape measure, comprehensive respiratory function test device (MasterScreen™ Body Plethysmography), Turkish version of the functional outcomes of the disease-specific quality of life sleep questionnaire (functional outcomes of sleep questionnaire, FOSQ,tr) The nottingham health profile includes the Epworth sleepiness scale.

Conclusion: The effects of aerobic and high-intensity interval training training will be interpreted by comparing the evaluations before and after treatment and between groups.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Function Loss Exercise Capacity Fatigue Selective Attention Physical Parameters	Other: Aerobic Exercise, High Intensity Interval Training	N/A

Detailed Description

Obstructive sleep apnea syndrome (OSAS) is a condition characterized by recurrent episodes of partial or complete obstruction of the upper airway (URI) during sleep. It results in recurrent awakenings and episodic oxyhemoglobin desaturations due to decreased ventilation. Clinical manifestations of the disease are snoring, witnessed apnea, suffocation, night sweats, nocturnal arrhythmias, excessive daytime sleepiness, personality changes, morning headache, decreased decision-making ability, forgetfulness, anxiety, depression, cardiovascular diseases, hypertension, myocardial infarction, cardiac It encompasses a wide spectrum of insufficiency, metabolic dysfunction, and cor pulmonale. There are 3 main causes of upper respiratory tract obstruction. These are the tone of the pharyngeal muscles, negative pressure during inspiration and the anatomical structure of the URI. Pharyngeal obstruction plays the most important role. The pharynx can be thought of as a tube devoid of a bony roof, and its opening is determined by the balance between the forces in the closing direction (such as negative intraluminal pressure and externally compressing adipose tissue) and the dilator muscles.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled experimental modelRandomized controlled experimental model

Masking:

Single (Participant)

Masking Description:

After the patients were selected from the relevant population with the improbable random sampling method, the patients who accepted to participate in the study and met the inclusion criteria will be assigned to one of the aerobic exercise group, high-intensity interval training training group or control group with the closed-envelope method.

Primary Purpose:

Treatment

Official Title:

The Effect of Aerobic and High-Intensity Interval Training on Respiratory Function, Exercise Capacity and Secondary Outcomes in Obstructive Sleep Apnea

Actual Study Start Date :

Jun 8, 2022

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control They will only receive standard medical treatment. In addition to the evaluation parameters applied, no additional information and/or exercise will be recommended other than routine clinical treatment and recommendations.
Experimental: Aerobic Exercise Aerobic exercise group; 3 days a week, 45-60 minutes will be carried out in the form of walking and jogging on the treadmill. Initially, warm-up exercises (10 minutes) will perform walking at 35-70% of maximum heart rate (HRmax). Then, aerobic exercises, the resistance and duration of which are increased according to the tolerance of the patient on the treadmill for 30-35 minutes, and at 60-70% of the HRmax, attention will be paid to ensure that the fatigue severity perceived by the patients is within the range of 12-14 according to the Modified Borg scale. Afterwards, the exercise program will be terminated with a cooling period (10 minutes) consisting of walking at a light pace.	Other: Aerobic Exercise, High Intensity Interval Training Aerobic exercise is a form of exercise done by consuming oxygen in order to give energy to the body. High Intensity Interval Training consists of low-intensity periods of active rest combined with short periods of intense exercise.
Experimental: High-İntensity İnterval Training The high-intensity interval training (HIIT) group, it will be performed as walking or jogging on the treadmill for 4X4 minutes (16 minutes in total) at ≥ 80% of HRmax, three times a week, with each session lasting a total of 38 minutes. Each training session will begin with a 10-minute warm-up period at 70% of HRmax. Between each 4-minute interval and after the last interval, patients will walk at 70% of HRmax for 3 minutes. Patients will check heart rate and target heart rate to control exercise intensity and will aim to reach their individual target heart rate after 1-1.5 minutes of exercise in each interval. The physical therapist, who oversees all training sessions, will check the patients' target heart rates.	Other: Aerobic Exercise, High Intensity Interval Training Aerobic exercise is a form of exercise done by consuming oxygen in order to give energy to the body. High Intensity Interval Training consists of low-intensity periods of active rest combined with short periods of intense exercise.

Arm

Intervention/Treatment

No Intervention: Control

They will only receive standard medical treatment. In addition to the evaluation parameters applied, no additional information and/or exercise will be recommended other than routine clinical treatment and recommendations.

Experimental: Aerobic Exercise

Aerobic exercise group; 3 days a week, 45-60 minutes will be carried out in the form of walking and jogging on the treadmill. Initially, warm-up exercises (10 minutes) will perform walking at 35-70% of maximum heart rate (HRmax). Then, aerobic exercises, the resistance and duration of which are increased according to the tolerance of the patient on the treadmill for 30-35 minutes, and at 60-70% of the HRmax, attention will be paid to ensure that the fatigue severity perceived by the patients is within the range of 12-14 according to the Modified Borg scale. Afterwards, the exercise program will be terminated with a cooling period (10 minutes) consisting of walking at a light pace.

Other: Aerobic Exercise, High Intensity Interval Training

Aerobic exercise is a form of exercise done by consuming oxygen in order to give energy to the body. High Intensity Interval Training consists of low-intensity periods of active rest combined with short periods of intense exercise.

Experimental: High-İntensity İnterval Training

The high-intensity interval training (HIIT) group, it will be performed as walking or jogging on the treadmill for 4X4 minutes (16 minutes in total) at ≥ 80% of HRmax, three times a week, with each session lasting a total of 38 minutes. Each training session will begin with a 10-minute warm-up period at 70% of HRmax. Between each 4-minute interval and after the last interval, patients will walk at 70% of HRmax for 3 minutes. Patients will check heart rate and target heart rate to control exercise intensity and will aim to reach their individual target heart rate after 1-1.5 minutes of exercise in each interval. The physical therapist, who oversees all training sessions, will check the patients' target heart rates.

Other: Aerobic Exercise, High Intensity Interval Training

Outcome Measures

Primary Outcome Measures

Pulmonary Function Tests [8 week]
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and ratios will be used in statistical analysis.(FEV1/FVC)
Exercise Capacity [8 week]
Exercise capacity will be evaluated with a 6-minute walk test. Evaluates the integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, blood, neuromuscular system, and muscle metabolism.

Secondary Outcome Measures

Fatigue [8 week]
It will be evaluated with the Fatigue Severity Scale. FSS is the most commonly used scale among the one-dimensional scales developed to assess fatigue.
Selective Attention [8 week]
The Stroop Test will be used to evaluate selective attention.
Disease-Specific quality of life [8 week]
Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).
General Health-Related Quality of Life [8 week]
Overall health-related quality of life will be assessed with the Nottingham Health Profile.
Daytime Sleepiness [8 week]
Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with moderate (AHI:16-30) and severe (AHI>30) OSAS by polysomnography.
Patients who are inactive according to the International Physical Activity Questionnaire-Short Form
Patients with symptoms of Obstructive Sleep Apnea Syndrome (snoring, respiratory arrest, and daytime sleepiness).

Exclusion Criteria:

Conditions that may make exercise dangerous. Patients with angina pectoris, congestive heart failure, cardiomyopathy, coronary artery disease, emphysema, inflammatory and malignant lung disease, pneumothorax.
Those with chronic obstructive pulmonary disease
Those who have recently had upper respiratory tract surgery.
Those with cooperation problems that would prevent the subject from successfully participating and completing the protocol, such as serious neurological, psychological, and medical problems.
Uncooperative patients.
Patients who previously received continuous positive airway pressure therapy
Behavior therapy training.
Patients already taking an exercise program.
Patients who cannot exercise due to musculoskeletal disorders.