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

NCT06087900 | Completed DMC

• 1 other identifier: EX PHYSIO SPSC 8
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

HIIT; Pulmonary function; Sleep; Exercise; Polysomnography

Outcome Measures

Primary Outcomes (6)

• Apnea-Hypopnea index (event/hr)

  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

  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)

  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

  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)

  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)

  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 Outcomes (9)

• Pulmonary function (Forced vital capacity; FVC)

  Change from baseline FVC at 12 weeks.

• Pulmonary function (Forced Expiratory Volume in one second; FEV1)

  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)

  Change from baseline FEV1/FVC at 12 weeks.

• Pulmonary function (Peak expiratory flow; PEF)

  Change from baseline PEF at 12 weeks.

• Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)

  Change from baseline FEF25-75% at 12 weeks.

Study Arms (4)

Moderate continuous training (MICT)

EXPERIMENTAL

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)

High intensity interval training (HIIT)

EXPERIMENTAL

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)

Inspiratory muscle training (IMT)

EXPERIMENTAL

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)

Control

SHAM COMPARATOR

The CON group did not have any intervention but usual care.

Other: Control

Interventions

Moderate continuous training (MICT) OTHER

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.

Moderate continuous training (MICT)

High intensity interval training (HIIT) OTHER

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.

High intensity interval training (HIIT)

Inspiratory muscle training (IMT) OTHER

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

Inspiratory muscle training (IMT)

Control OTHER

The CON group did not have any intervention but usual care.

Control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
• BMI between 18.5 - 24.9 kg/ m2.
• No history of exercise more than 150 min/week for 4 weeks.
• No used CPAP or discontinue at least 2 weeks.
• 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
• \. Not a person with current smoker, menopause or pregnancy. 8. Stable medication. 9. Willing to participate in this research.

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (5)

• Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.

  PMID: 29616142 RESULT

• Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.

  PMID: 22131599 RESULT

• Nobrega-Junior JCN, Dornelas de Andrade A, de Andrade EAM, Andrade MDA, Ribeiro ASV, Pedrosa RP, Ferreira APL, de Lima AMJ. Inspiratory Muscle Training in the Severity of Obstructive Sleep Apnea, Sleep Quality and Excessive Daytime Sleepiness: A Placebo-Controlled, Randomized Trial. Nat Sci Sleep. 2020 Dec 2;12:1105-1113. doi: 10.2147/NSS.S269360. eCollection 2020.

  PMID: 33293881 RESULT

• Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.

  PMID: 28117479 RESULT

• Krittayaphong R, Bhuripanyo K, Raungratanaamporn O, Chotinaiwatarakul C, Chaowalit N, Punlee K, Kangkagate C, Chaithiraphan S. Reliability of Thai version of SF-36 questionnaire for the evaluation of quality of life in cardiac patients. J Med Assoc Thai. 2000 Nov;83 Suppl 2:S130-6.

  PMID: 11194004 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wannaporn Tongtako

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 18, 2023
• Study Start: August 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: July 9, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)