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

NCT ID: NCT05416398

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-12-20

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.

Conditions

Respiratory Function Loss; Exercise Capacity; Fatigue; Selective Attention; Physical Parameters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Aerobic Exercise, High Intensity Interval Training

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Aerobic Exercise, High Intensity Interval Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Engin Ramazanoglu

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit

Malatya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

engin ramazanoglu, PhD student

Role: CONTACT

enginramazanoglu@hotmail.com

+905449449322

Burcu TALU, PhD

Role: CONTACT

fzt.burcu@hotmail.com

Facility Contacts

Turgut Özal Medical Center Department of Chest Diseases

Role: primary

totm@inonu.edu.tr

00 90 422 341 06 60

References

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. doi: 10.1007/s11325-006-0095-5.

Reference Type: BACKGROUND

PMID: 17221274 (View on PubMed)

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. doi: 10.4317/medoral.17706.

Reference Type: RESULT

PMID: 22549673 (View on PubMed)

Garcia-Ortega A, Manas E, Lopez-Reyes R, Selma MJ, Garcia-Sanchez A, Oscullo G, Jimenez D, Martinez-Garcia MA. Obstructive sleep apnoea and venous thromboembolism: pathophysiological links and clinical implications. Eur Respir J. 2019 Jan 31;53(2):1800893. doi: 10.1183/13993003.00893-2018. Print 2019 Feb.

Reference Type: RESULT

PMID: 30385528 (View on PubMed)

Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.

Reference Type: RESULT

PMID: 16963682 (View on PubMed)

Other Identifiers

2022/57

Identifier Type: -

Identifier Source: org_study_id