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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416398
• Other study ID #: 2022/57
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: June 2022
• Source: Inonu University
• Contact: engin ramazanoglu, PhD student
• Phone: +905449449322
• Email: enginramazanoglu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Capacity
• Fatigue
• Respiratory Function Loss
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Turkey	Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Azagra-Calero E, Espinar-Escalona E, Barrera-Mora JM, Llamas-Carreras JM, Solano-Reina E. Obstructive sleep apnea syndrome (OSAS). Review of the literature. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e925-9. Review. — View Citation

García-Ortega A, Mañas E, López-Reyes R, Selma MJ, García-Sánchez A, Oscullo G, Jiménez D, Martínez-García MÁ. Obstructive sleep apnoea and venous thromboembolism: pathophysiological links and clinical implications. Eur Respir J. 2019 Jan 31;53(2). pii: 1 — View Citation

Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. — View Citation

Quan SF, O'Connor GT, Quan JS, Redline S, Resnick HE, Shahar E, Siscovick D, Sherrill DL. Association of physical activity with sleep-disordered breathing. Sleep Breath. 2007 Sep;11(3):149-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Tests	Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and ratios will be used in statistical analysis.(FEV1/FVC)	8 week
Primary	Exercise Capacity	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.	8 week
Secondary	Fatigue	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.	8 week
Secondary	Selective Attention	The Stroop Test will be used to evaluate selective attention.	8 week
Secondary	Disease-Specific quality of life	Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).	8 week
Secondary	General Health-Related Quality of Life	Overall health-related quality of life will be assessed with the Nottingham Health Profile.	8 week
Secondary	Daytime Sleepiness	Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.	8 week