Effect of Different Exercise Modalities Training in Patients With Obstructive Sleep Apnea.

October 17, 2023 updated by: Chulalongkorn University

Effects of Different Exercise Modalities on Apnea-Hypopnea Index and Oxidative Stress in Patients With Obstructive Sleep Apnea.

The objective of this study was to compare different exercise modalities (moderate continuous intensity training, high intensity interval training, and inspiratory muscle training) on Apnea-Hypopnea index and oxidative stress in patients with Obstructive sleep apnea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forty patients with OSA aged 20 and 50 years old, dividing into 4 groups (MICT, HIIT, IMT, and CON) by stratified (with sex, age, and OSA severity) and single random sampling. The MICT group received 50 minutes of running at 65-70% of maximum heart rate 3 days/week for 12 weeks. The HIIT groups received 28 minutes of running (High intensity at 85-90% of maximum heart rate 2 minutes interval with low intensity 50-55% of maximum heart rate 2 minutes) 3 days/week for 12 weeks. The IMT group received Powerbreathe ® device, performing 240 breath (8 sets) per day at 50% of Maximal inspiratory pressure (MIP), 5 days/week for 12 week. The CON group did not have any intervention but usual care. Data collection was split 2 days (1st day for polysomnography evaluation, and 2nd day for questionnaire, blood collection, body composition, exhaled nitric oxide, pulmonary function, respiratory muscle strength and aerobic capacity). All variables were measured before and after exercise program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Faculty of Sports Science, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
  2. BMI between 18.5 - 24.9 kg/ m2.
  3. No history of exercise more than 150 min/week for 4 weeks.
  4. No used CPAP or discontinue at least 2 weeks.
  5. No history for surgery for OSA treatment. Screened by physician that patients have not had Uncontrolled diabetes (blood sugar 180 mg/dL) Uncontrolled hypertension (BP 139/89 mmHg) Any coronary artery disease Any neuromuscular disease Chronic Obstructive Pulmonary Disease; COPD Any cognitive disease Other sleep-related disorders Cancer

7. Not a person with current smoker, menopause or pregnancy. 8. Stable medication. 9. Willing to participate in this research.

Exclusion Criteria:

  1. Cannot participate at least 80% of exercise program.
  2. Inevitable event (injury, sickness, etc.)
  3. Unwilling to continue this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moderate continuous training (MICT)
The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12.
Other: Moderate continuous training (MICT)
The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12.
Experimental: High intensity interval training (HIIT)
The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12.
Other: High intensity interval training (HIIT)
The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12.
Experimental: Inspiratory muscle training (IMT)
The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory
Other: Inspiratory muscle training (IMT)
The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory
Sham Comparator: Control
The CON group did not have any intervention but usual care.
Other: Control
The CON group did not have any intervention but usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea index (event/hr)
Time Frame: Change from Baseline Apnea-Hypopnea index at 12 weeks.
The study performed polysomnography in the sleep laboratory using standard EEG with frontal leads (F1, F2), central leads (C3, C4), occipital leads (O1, O2), and reference leads at mastoids (M1, M2). Electromyography and electrooculography were also used. Oxygen saturation (SpO2) was measured using a finger probe. Air flow was measured using two methods: a nasal pressure transducer and an oral-nasal thermocouple. Respiratory movements of the thorax and abdomen were monitored using respiratory inductance plethysmography. The position of the body was measured using a position sensor attached to the anterior chest wall on the thoracic belt.
Change from Baseline Apnea-Hypopnea index at 12 weeks.
Oxidative stress
Time Frame: Change from Baseline Oxidative stress at 12 weeks.
Blood was collected into sterile ethylenediaminetetraacetic acid (EDTA) tubes from the cubital vein by a nurse at Exercise Physiology laboratory, Chulalongkorn University. The collected blood was analyzed by a medical technologist. To obtain plasma, the EDTA blood samples were centrifuged at 3,000 rpm for 10 minutes. All plasma samples were stored at a temperature of -80°C until they were used for various assays.
Change from Baseline Oxidative stress at 12 weeks.
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
The Pittsburgh Sleep Quality Index (PSQI) Thai version was evaluated at baseline and post-intervention to assess subjective sleep quality over the previous 2 weeks. This index aimed to evaluate their subjective sleep quality over the preceding two weeks. The PSQI provided seven component scores, which included assessments of sleep quality, the time taken to fall asleep, the duration of sleep, the regularity of sleep, disturbances during sleep, the use of sleep medications, and daytime dysfunction. By summing up the scores from these subscales, a global score ranging from 0 to 21 was calculated. A global score above 5 is generally considered an indication of poor sleep quality.
Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
The Short Form-36 (SF-36) questionnaire
Time Frame: Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
The Short Form-36 (SF-36) questionnaire Thai version was evaluated at baseline and post-intervention. This questionnaire consists of 36 questions that are used to assess quality of life (QoL) across eight domains related to both physical and mental health. These domains include physical functioning, role limitations due to physical health (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional health (role-emotional), and mental health. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better health-related quality of life (HRQL) compared to lower scores.
Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
The Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame: Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
The Functional Outcomes of Sleep Questionnaire (FOSQ) Thai version was evaluated at baseline and post-intervention. This questionnaire specifically designed to assess health-related quality of life in relation to sleep disorders. It comprises 30 items that examine five domains related to normal daily life: general productivity (8 items), vigilance (7 items), social outcome (2 items), activity level (9 items), and sexual relationship (4 items). Each subscale and a global score were calculated, with the subscale scores ranging from 1 to 4 and the global score ranging from 5 to 20. A lower score indicates a higher level of dysfunction or poorer quality of life.
Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
The Epworth sleepiness scale (ESS)
Time Frame: Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.
The Epworth sleepiness scale (ESS) Thai version was evaluated at baseline and post-intervention. This questionnaire is used to assess excessive daytime sleepiness (EDS). The questionnaire consists of eight scenarios where individuals rate their potential for dozing off or falling asleep on a scale of 0 to 3. The ESS has demonstrated excellent internal consistency and test-retest reliability, making it suitable for assessing the effectiveness of interventions. A total ESS score greater than 10 indicates the presence of EDS and a high risk of sleep-related breathing disorders.
Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary function (Forced vital capacity; FVC)
Time Frame: Change from baseline FVC at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FVC will be reported in liter (L).
Change from baseline FVC at 12 weeks.
Pulmonary function (Forced Expiratory Volume in one second; FEV1)
Time Frame: Change from baseline FEV1 at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).
Change from baseline FEV1 at 12 weeks.
Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
Time Frame: Change from baseline FEV1/FVC at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).
Change from baseline FEV1/FVC at 12 weeks.
Pulmonary function (Peak expiratory flow; PEF)
Time Frame: Change from baseline PEF at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. PEF will be reported in liter per minute (L/min).
Change from baseline PEF at 12 weeks.
Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)
Time Frame: Change from baseline FEF25-75% at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEF25-75% will be reported in liter per second (L/sec).
Change from baseline FEF25-75% at 12 weeks.
Pulmonary function (Maximal voluntary ventilation; MVV)
Time Frame: Change from baseline MVV at 12 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).
Change from baseline MVV at 12 weeks.
Respiratory muscle strength
Time Frame: Change from baseline Respiratory muscle strength at 12 weeks.
Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.
Change from baseline Respiratory muscle strength at 12 weeks.
Exhaled nitric oxide (ppb)
Time Frame: Change from baseline Exhaled nitric oxide at 12 weeks.
The participants were instructed to sit upright and hold the device (NObreath, BedFont, UK). They were asked to take a deep breath and fill their lungs completely, and then exhale through the mouthpiece while ensuring that the ball in the flow indicator remained in the middle of the white band. The exhalation time was set at 12 seconds. Each participant was requested to repeat the measurement three times.
Change from baseline Exhaled nitric oxide at 12 weeks.
Aerobic capacity (ml/kg/min)
Time Frame: Change from baseline Aerobic capacity at 12 weeks.
Participants were prepared for a 4-lead electrocardiogram before undergoing exercise tests on a treadmill equipped with a gas analyzer. The protocol began at an intensity of approximately 2 METs and involved increments in speed and/or grade every 20 seconds, equivalent to 0.3 METs. During the last 20 seconds of each 3-minute segment, the speed and grade settings matched those of the standard Bruce protocol (e.g., 3 minutes: 1.7 mph, 10% grade). Heart rate measurements were taken during the last 5 seconds of every minute and at peak exercise. Participants were asked to rate their perceived exertion during the last 5 seconds of each minute and immediately after the test (peak rating of perceived exertion). Blood pressure was measured during the last 30 seconds of minutes 3, 6, 9, and 11, as well as immediately after the test.
Change from baseline Aerobic capacity at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wannaporn Tongtako, Area of Exercise Physiology, Faculty of Sports Science, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX PHYSIO SPSC 8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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