12-week Tele-exercise Program in Patients With OSA

NCT06467682 | Not Yet Recruiting DMC

• 2 other identifiers: EEBK/EP 2023/60101034403
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obstructive sleep apnea (OSA) contributes to a number of adverse health effects, particularly on brain health. Chronic sleep disturbances caused by OSA could adversely affect cognitive health. Exercise is recommended as a non-pharmacological intervention for patients who are intolerant to continuous positive airway pressure (CPAP) and has been shown to have beneficial effects on brain health and cognitive function. The aim of this protocol is to investigate the effects of a 12-week tele-exercise program on cognitive function and specific parameters of brain activity, including brain metabolism and oxygenation, in patients with OSA. The project aims to demonstrate the multi-dimensional relationship between exercise, cognition and brain oxygenation/metabolism. Our local ethics committee has approved the study. Our population sample (group A = OSA with cognitive impairment (CI) and tele-exercise; group B = OSA with CI and no tele-exercise; group C = OSA without CI and no tele-exercise) will undergo assessment both before and after a 12-week tele-exercise intervention program. This assessment will include a comprehensive battery of subjective and objective assessment tests. Data will be analysed according to group stratification. We hypothesize a beneficial effect of tele-exercise on sleep and cognitive parameters and we are confident that this study will raise awareness among healthcare professionals of the brain health benefits of exercise in patients with low compliance to CPAP treatment.

Conditions

Obstructive Sleep Apnea; Cognitive Impairment

Keywords

tele-rehabilitation; tele-exercise; brain health

Outcome Measures

Primary Outcomes (1)

• The primary aim of this study is to investigate the extent to which tele-exercise improves cognitive functions in patients with OSA

  Absolute number (scale score) in both the total score and the domains of the MoCA questionnaire (assessing cognitive impairment), individual patient, between baseline and after 12 weeks of intervention.

  Baseline and after 12-week

Secondary Outcomes (5)

• To investigate the extent to which tele-exercise has a positive impact on brain oxygenation in patients with OSA.

  Baseline and after 12-week

• To investigate the extent to which tele-exercise has a positive impact on brain metabolism in patients with OSA.

  Baseline and after 12-week

• Investigate the extent to which tele-exercise has a positive impact on sleep architecture in patients with OSA.

  Baseline and after 12-week

• To investigate to what extent tele-exercise has a positive effect on oxygen saturation during sleep in patients with OSA.

  Baseline and after 12-week

• To investigate the extent to which tele-exercise has a positive impact on Apnea Hypopnea Index in patients with OSA.

  Baseline and after 12-week

Study Arms (1)

12-week intervention tele-exercise program

OTHER

tele-exercise and tele-rehabilitation

Other: tele-exercise

Interventions

tele-exercise OTHER

The 12-week tele-exercise program will be performed and supported via the USTEP digital platform, with each patient taking part in 3 training sessions per week with a 60-min duration period per training session. There will be personalized training sessions: i) warm-up and warm-down, ii) aerobic exercise, and iii) strength exercises. All tele-exercise program participants, will use wearable-based tracking to assessment the cardio-oxygenation.

12-week intervention tele-exercise program

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18-to-≤70 years,
• apnea hypopnea index (AHI) ≥15 events/h,
• no contraindications (e.g. unstable angina during the previous month, myocardial infarction during the previous month, resting heart rate \>120 bpm, systolic blood pressure \>180 mmHg and diastolic blood pressure \>100 mmHg) for 6-minute walk test (6MWT)
• body mass index (BMI) \<40 kg/m2
• without daily physical working strain
• without active self-reported symptoms (fatigue and dyspnea)
• without pregnancy for women
• patients with preexistent musculoskeletal disability will be excluded since their condition might impair maximum exercise capacity
• all participants should speak and read Greek

Sponsors & Collaborators

• University of Cyprus: lead

Related Publications (1)

• Stavrou VT, Pitris K, Constantinidou F, Adamide T, Frangopoulos F, Bargiotas P. The impact of a 12-week tele-exercise program on cognitive function and cerebral oxygenation in patients with OSA: randomized controlled trial-protocol study. Front Sports Act Living. 2024 Sep 6;6:1418439. doi: 10.3389/fspor.2024.1418439. eCollection 2024.

  PMID: 39346497 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 21, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share