Clinical trial NCT06087900: Effect of Different Exercise Modalities Training in Patients With Obstructive Sleep Apnea.
Official title: Effects of Different Exercise Modalities on Apnea-Hypopnea Index and Oxidative Stress in Patients With Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: HIIT
Pulmonary function
Sleep
Exercise
Polysomnography
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-Hypopnea index (event/hr)
timeFrame: Change from Baseline Apnea-Hypopnea index at 12 weeks.
measure: Oxidative stress
timeFrame: Change from Baseline Oxidative stress at 12 weeks.
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
measure: The Short Form-36 (SF-36) questionnaire
timeFrame: Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
measure: The Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
measure: The Epworth sleepiness scale (ESS)
timeFrame: Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.
Secondary outcomes:
measure: Pulmonary function (Forced vital capacity; FVC)
timeFrame: Change from baseline FVC at 12 weeks.
measure: Pulmonary function (Forced Expiratory Volume in one second; FEV1)
timeFrame: Change from baseline FEV1 at 12 weeks.
measure: Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
timeFrame: Change from baseline FEV1/FVC at 12 weeks.
measure: Pulmonary function (Peak expiratory flow; PEF)
timeFrame: Change from baseline PEF at 12 weeks.
measure: Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)
timeFrame: Change from baseline FEF25-75% at 12 weeks.
measure: Pulmonary function (Maximal voluntary ventilation; MVV)
timeFrame: Change from baseline MVV at 12 weeks.
measure: Respiratory muscle strength
timeFrame: Change from baseline Respiratory muscle strength at 12 weeks.
measure: Exhaled nitric oxide (ppb)
timeFrame: Change from baseline Exhaled nitric oxide at 12 weeks.
measure: Aerobic capacity (ml/kg/min)
timeFrame: Change from baseline Aerobic capacity at 12 weeks.
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Wannaporn Tongtako
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.