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Status unknownNCT05416398Updated Jun 13, 2022

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

An interventional study of Aerobic Exercise, High Intensity Interval Training in Respiratory Function Loss, Exercise Capacity and Fatigue, sponsored by Inonu University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Aerobic Exercise
  • Exercise Tolerance
  • High Intensity Interval Training
  • Obstructive Sleep Apnea
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 33 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
33 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherAerobic 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.

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What researchers measure

Primary outcomes

  1. Pulmonary Function Tests

    Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and ratios will be used in statistical analysis.(FEV1/FVC)

    Time frame: 8 week

  2. 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.

    Time frame: 8 week

Secondary outcomes

  1. 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.

    Time frame: 8 week

  2. Selective Attention

    The Stroop Test will be used to evaluate selective attention.

    Time frame: 8 week

  3. Disease-Specific quality of life

    Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).

    Time frame: 8 week

  4. General Health-Related Quality of Life

    Overall health-related quality of life will be assessed with the Nottingham Health Profile.

    Time frame: 8 week

  5. Daytime Sleepiness

    Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.

    Time frame: 8 week

07

Study locations

1 of 1 sites recruiting
  • Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit
    Malatya, 44000, Turkey
    • Turgut Özal Medical Center Department of Chest Diseases · Contact · totm@inonu.edu.tr · 00 90 422 341 06 60
    Recruiting
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References and documents

Publications

  • 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. PubMed 17221274 ↗
  • 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. PubMed 22549673 ↗
  • 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. PubMed 30385528 ↗
  • 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. PubMed 16963682 ↗

Individual participant data

Plan to share: No — It will not be shared in order to protect the privacy and confidentiality of patient information.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05416398
Lead sponsor
Inonu University
Responsible party
Engin Ramazanoglu (Researcher, Inonu University) — Principal investigator
First posted
Jun 13, 2022
Start date
Jun 8, 2022
Primary completion
Dec 20, 2023 (estimated)
Completion
Dec 20, 2023 (estimated)
Last update
Jun 13, 2022

Study contacts

engin ramazanoglu, PhD student
Contact
enginramazanoglu@hotmail.com
+905449449322
Burcu TALU, PhD
Contact
fzt.burcu@hotmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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