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

Primary Purpose

Respiratory Function Loss, Exercise Capacity, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise, High Intensity Interval Training
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Function Loss focused on measuring Aerobic Exercise, Exercise Tolerance, High Intensity Interval Training, Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Aerobic Exercise

High-İntensity İnterval Training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Selective Attention
The Stroop Test will be used to evaluate selective attention.
Disease-Specific quality of life
Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).
General Health-Related Quality of Life
Overall health-related quality of life will be assessed with the Nottingham Health Profile.
Daytime Sleepiness
Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.

Full Information

First Posted
June 8, 2022
Last Updated
June 8, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05416398
Brief Title
Effects of High-intensity Interval Training and Aerobic Exercise on Obstructive Sleep Apnea.
Official Title
The Effect of Aerobic and High-Intensity Interval Training on Respiratory Function, Exercise Capacity and Secondary Outcomes in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Function Loss, Exercise Capacity, Fatigue, Selective Attention, Physical Parameters
Keywords
Aerobic Exercise, Exercise Tolerance, High Intensity Interval Training, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental model
Masking
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.
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
High-İntensity İnterval Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise, High Intensity Interval Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Function Tests
Description
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
Title
Exercise Capacity
Description
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 Outcome Measure Information:
Title
Fatigue
Description
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
Title
Selective Attention
Description
The Stroop Test will be used to evaluate selective attention.
Time Frame
8 week
Title
Disease-Specific quality of life
Description
Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).
Time Frame
8 week
Title
General Health-Related Quality of Life
Description
Overall health-related quality of life will be assessed with the Nottingham Health Profile.
Time Frame
8 week
Title
Daytime Sleepiness
Description
Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
engin ramazanoglu, PhD student
Phone
+905449449322
Email
enginramazanoglu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu TALU, PhD
Email
fzt.burcu@hotmail.com
Facility Information:
Facility Name
Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit
City
Malatya
ZIP/Postal Code
44000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Turgut Özal Medical Center Department of Chest Diseases
Phone
00 90 422 341 06 60
Email
totm@inonu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will not be shared in order to protect the privacy and confidentiality of patient information.
Citations:
PubMed Identifier
17221274
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. doi: 10.1007/s11325-006-0095-5.
Results Reference
background
PubMed Identifier
22549673
Citation
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.
Results Reference
result
PubMed Identifier
30385528
Citation
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.
Results Reference
result
PubMed Identifier
16963682
Citation
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.
Results Reference
result

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

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