Investigating the Combined Effects of Intermittent Hypoxia and Exercise on Cognitive and Cerebral Function in Middle-Aged Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorAyoub Boulares

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hypoxia, intermittent

    Other intervention

    Moderate-Intensity Aerobic Exercise (\~60-70% of maximum heart rate) and Intermittent Hypoxia (maintained between 80-90% during hypoxic phases)

  • physical exercise

    Other intervention

    Moderate-Intensity Aerobic Exercise (\~60-70% of maximum heart rate)

  • Sham (No Treatment) hypoxia

    Other intervention

    Exposure to normoxic air (FiO₂ \~20.9%) instead of actual hypoxia.

Treatment groups

176 Participants
are divided into 5 treatment groups
Group A: Intermittent Hypoxia OnlyExperimental treatment 1 intervention
Group B: Physical exercise onlyExperimental treatment 1 intervention
Group C: Sequential Combination of Intermittent Hypoxia (IH) and Physical Activity (PA)Experimental treatment 2 interventions
Group D: Simultaneous Combination of Intermittent Hypoxia (IH) and Physical Activity (PA)Experimental treatment 2 interventions
Group E: Sham (Placebo) Intermittent HypoxiaPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive Function: Montreal Cognitive Assessment (MoCA)

1-Montreal Cognitive Assessment (MoCA) * Score Range: 0 to 30 * Interpretation: Higher scores indicate better cognitive function.

Time frame
Baseline (Week 0),Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18)
2

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.

Time frame
Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18)
3

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.

Time frame
Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18)
4

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.

Time frame
Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18)

Secondary outcomes

1

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.

Time frame
Baseline, and post-intervention (week 6, session 18)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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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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