Respiratory Function LossNCT05416398
Effects of High-intensity Interval Training and Aerobic Exercise on Obstructive Sleep Apnea.
A study testing Aerobic Exercise, High Intensity Interval Training in people with Respiratory Function Loss and Exercise Capacity, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Respiratory Function Loss, Exercise Capacity, Fatigue
- What is being tested?
- Aerobic Exercise, High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2022to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Behavior therapy training.
- Patients already taking an exercise program.
- Patients who cannot exercise due to musculoskeletal disorders.
Trial locations and contacts
1 site in 1 country.
Burcu TALU, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University, Turgut Özal Medical Center, Department of Chest Diseases, Pulmonary Rehabilitation unit
Malatya, 44000
Turgut Özal Medical Center Department of Chest Diseases, 00 90 422 341 06 60, totm@inonu.edu.tr
About this study
Official title: The Effect of Aerobic and High-Intensity Interval Training on Respiratory Function, Exercise Capacity and Secondary Outcomes in Obstructive Sleep Apnea
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.
Read more
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.
- Conditions
- Respiratory Function Loss, Exercise Capacity, Fatigue, Selective Attention, Physical Parameters
- Being tested
- Aerobic Exercise, High Intensity Interval Training
- Keywords
- Aerobic Exercise, Exercise Tolerance, High Intensity Interval Training, Obstructive Sleep Apnea
- Medical subject headings
- Fatigue, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise, High Intensity Interval TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Experimental | 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. Receives: Other: Aerobic Exercise, High Intensity Interval Training |
| High-İntensity İnterval Training | Experimental | 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. Receives: Other: Aerobic Exercise, High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Tests
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and ratios will be used in statistical analysis.(FEV1/FVC)
Measured: 8 week
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.
Measured: 8 week
Secondary outcomes (5)
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.
Measured: 8 week
Selective Attention
The Stroop Test will be used to evaluate selective attention.
Measured: 8 week
Disease-Specific quality of life
Disease-Specific quality of life will be evaluated with Functional Outcomes of Sleep Questionnaire, FOSQ,tr).
Measured: 8 week
General Health-Related Quality of Life
Overall health-related quality of life will be assessed with the Nottingham Health Profile.
Measured: 8 week
Daytime Sleepiness
Epworth Sleepiness Scale will be used to measure the general sleepiness of the patients during the day.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start8 Jun 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function LossStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416398
- Sponsor's protocol ID
- 2022/57
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will not be shared in order to protect the privacy and confidentiality of patient information.
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 17221274Azagra-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 22549673Garcia-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 30385528Jones 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic and High-Intensity Interval Training on Respiratory Function, Exercise Capacity and Secondary Outcomes in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05416398
- Acronym / sponsor ID
- 2022/57
- Conditions
- Respiratory Function Loss, Exercise Capacity, Fatigue, Selective Attention, Physical Parameters
- Keywords
- Aerobic Exercise, Exercise Tolerance, High Intensity Interval Training, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled experimental model
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Experimental | Other: Aerobic Exercise, High Intensity Interval TrainingAerobic 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. |
| High-İntensity İnterval Training | Experimental | Other: Aerobic Exercise, High Intensity Interval TrainingThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise, High Intensity Interval TrainingAerobic 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. | Other | Aerobic Exercise, High-İntensity İnterval Training |
Primary outcome
Pulmonary Function Tests
Time frame: 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
Time frame: 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.
5 secondary outcomes
Fatigue
Time frame: 8 week
Selective Attention
Time frame: 8 week
Disease-Specific quality of life
Time frame: 8 week
General Health-Related Quality of Life
Time frame: 8 week
Daytime Sleepiness
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 17221274Quan 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 publication: PubMed 22549673Azagra-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 publication: PubMed 30385528Garcia-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 publication: PubMed 16963682Jones 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.
- Individual participant dataSharing planned: No. It will not be shared in order to protect the privacy and confidentiality of patient information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu TALU, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, High Intensity Interval Training in people with Respiratory Function Loss and Exercise Capacity, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact engin ramazanoglu, PhD student (+905449449322, enginramazanoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Tests (time frame: 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416398, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.