About this trial
This study investigates whether intermittent hypoxia (IH) and physical activity (PA), either alone or in combination (simultaneously or sequentially), can improve cognitive function and brain health in middle-aged adults (50-65 years old). The hypothesis is that (1) each intervention alone (IHT or PA) provides cognitive benefits and (2) combining IHT with PA may yield additive or synergistic effects, particularly when administered simultaneously rather than sequentially. By comparing these distinct interventions, the study aims to determine which approach best preserves or enhances cognitive performance in middle-aged adults. Findings from this research may inform non-pharmacological strategies to promote healthy aging and reduce the risk of age-related cognitive decline.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 50 to 65 years (male and female)
Montreal Cognitive Assessment (MoCA) score ≥ 24
No participation in any structured exercise intervention in the last 6 months
No exposure to altitudes above 1,500 m in the preceding 3 months
Disqualifiers
Active smoking
Major cardiovascular complications within the last 3 months (e.g., myocardial i-infarction, unstable angina, severe arrhythmias)
Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic)
Chronic respiratory insufficiency (e.g., COPD, sleep apnea)
Trial design
Parallel
Treatments tested in this trial
Hypoxia, intermittent
Other interventionModerate-Intensity Aerobic Exercise (\~60-70% of maximum heart rate) and Intermittent Hypoxia (maintained between 80-90% during hypoxic phases)
physical exercise
Other interventionModerate-Intensity Aerobic Exercise (\~60-70% of maximum heart rate)
Sham (No Treatment) hypoxia
Other interventionExposure to normoxic air (FiO₂ \~20.9%) instead of actual hypoxia.
Treatment groups
Trial outcomes
Primary outcomes
Cognitive Function: Montreal Cognitive Assessment (MoCA)
1-Montreal Cognitive Assessment (MoCA) * Score Range: 0 to 30 * Interpretation: Higher scores indicate better cognitive function.
Cerebral Oxygenation - Tissue Saturation Index (TSI)
* Method: Near-Infrared Spectroscopy (NIRS) * Measure: Tissue Saturation Index (TSI), expressed as a percentage (%) * Interpretation: Higher TSI values indicate better cerebral oxygenation, reflecting efficient oxygen delivery and utilization in brain tissue.
Biomarker Analysis- Brain-Derived Neurotrophic Factor (BDNF) Levels
* Method: Enzyme-Linked Immunosorbent Assay (ELISA) * Unit of Measure: pg/mL * Interpretation: Higher BDNF levels indicate greater neuroplasticity, neuronal survival, and cognitive function support.
Cerebral blood flow
Method: Transcranial Doppler (TCD) Measures: Mean, systolic, and diastolic blood flow velocities in cerebral arteries. Interpretation: Higher flow velocities indicate increased cerebral perfusion, while reduced velocities may reflect impaired blood flow regulation or vascular resistance.
Secondary outcomes
Autonomy and Daily Functioning (Activities of Daily Living Scale)
* Full Name: Activities of Daily Living (ADL) Scale * Description: This scale assesses an individual's ability to perform essential daily activities independently. It evaluates functions such as dressing, bathing, eating, mobility, toileting, and grooming. * Score Range: 0 to 6 * Interpretation: A higher score indicates greater independence, while a lower score reflects higher dependency in daily functioning.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ayoub Boulares
Lead sponsor
University of Poitiers
Sponsor institution
University of Poitiers
Collaborator
Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France
Collaborator
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