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

Not Applicable

• Conditions: Exercise Capacity; Fatigue; Physical Parameters; Respiratory Function Loss; Selective Attention

• Registration Number: NCT05416398
• Lead Sponsor: Inonu University

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.

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 Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-08
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Disease-Specific quality of life	8 week	Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).
Selective Attention	8 week	The Stroop Test will be used to evaluate selective attention.
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.

Trial Locations

Locations (1)

Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit; 🇹🇷 Malatya, Turkey