[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583289":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":44,"centralContacts":49,"locations":44,"responsibleParty":59,"collaborators":63,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":44,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":102,"whyStopped":44,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":44},{"fullName":5,"class":6},"University of Poitiers","OTHER",[8,14,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent Hypoxia Only","EXPERIMENTAL","Participants in this arm will undergo a protocol of repeated cycles of hypoxia and normoxia. Each session will consist of alternating 5-minute hypoxic exposures with 5-minute normoxic intervals, for a total of approximately 30 minutes per session. Sessions will be held three times per week for six weeks (18 total sessions), and will be conducted at rest inside a hypoxic chamber under clinical supervision.",[13],"Other: Hypoxia, intermittent",{"label":15,"type":10,"description":16,"interventionNames":17},"Physical exercise only","Participants allocated to this arm will engage in a moderate-intensity aerobic exercise program (\\~60-70% of age-predicted maximum heart rate and based on a standardized scale of perceived exertion) three times per week for six weeks (total of 18 sessions). Each session will last approximately 30 minutes and may involve activities such as treadmill walking, cycling, or other forms of continuous aerobic exercise. The exercise intensity is monitored (e.g., via heart rate or perceived exertion) to ensure a moderate level of effort that is both safe and beneficial for overall cardiovascular and cognitive health.",[18],"Other: physical exercise",{"label":20,"type":10,"description":21,"interventionNames":22},"Sequential Combination of Intermittent Hypoxia (IH) and Physical Activity (PA)","Participants in this arm will undergo both Intermittent Hypoxia Training (IH) and Physical Activity (PA) within the same session, but in a sequential manner. The order of interventions (IH first or PA first) will be randomized to account for potential order effects. Each session consists of 30 minutes of IHT (5-minute hypoxia cycles, followed by 5-minute normoxic intervals, with SpO₂ maintained between 80% and 90%) and 30 minutes of moderate-intensity aerobic exercise (e.g., treadmill walking, cycling). Sessions will be held three times per week for six weeks (18 total sessions) and will be conducted under clinical supervision in a controlled environment.",[13,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Simultaneous Combination of Intermittent Hypoxia (IH) and Physical Activity (PA)","Participants in this arm will undergo Intermittent Hypoxia (IH) and Physical Activity (PA) simultaneously within the same session. During each session, participants will engage in moderate-intensity aerobic exercise (e.g., treadmill walking or cycling) while being exposed to IH. The total session duration will be 30 minutes, consisting of repeated cycles of 5 minutes of hypoxia followed by 5 minutes of normoxia, with SpO₂ maintained between 80% and 90% during hypoxic intervals. Sessions will be conducted three times per week for six weeks (18 total sessions) under clinical supervision in a controlled environment.",[13,18],{"label":28,"type":29,"description":30,"interventionNames":31},"Sham (Placebo) Intermittent Hypoxia","PLACEBO_COMPARATOR","Participants in this arm will undergo a sham (placebo) version of Intermittent Hypoxia (IH), where they will be exposed to normoxic air (FiO₂ \\~20.9%) instead of actual hypoxia. The session structure will mimic the IH protocol, alternating between 5-minute \"hypoxia\" periods and 5-minute normoxia periods for a total of 30 minutes per session, but without a real reduction in oxygen levels. Sessions will be held three times per week for six weeks (18 total sessions) and will be conducted at rest inside a hypoxic chamber under clinical supervision.",[32],"Other: Sham (No Treatment) hypoxia",[34,40,45],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Hypoxia, intermittent","Moderate-Intensity Aerobic Exercise (\\~60-70% of maximum heart rate) and Intermittent Hypoxia (maintained between 80-90% during hypoxic phases)",[9,20,24],[39],"hypoxic expousre",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"physical exercise","Moderate-Intensity Aerobic Exercise (\\~60-70% of maximum heart rate)",[15,20,24],null,{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"Sham (No Treatment) hypoxia","Exposure to normoxic air (FiO₂ \\~20.9%) instead of actual hypoxia.",[28],[50,55],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},"Aurélien PICHIN, Professor","CONTACT","+33 6 82 95 19 70","aurelien.pichon@univ-poitiers.fr",{"name":56,"role":52,"phone":57,"phoneExt":44,"email":58},"Ayoub Boulares, PhD student","+33 6 10 11 39 01","ayoub.boualres@univ-poitiers.fr",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Ayoub Boulares","Principal Investigator, PhD student",[64,65],{"name":5,"class":6},{"name":66,"class":67},"Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France","UNKNOWN","100583289","investigating-the-combined-effects-of-intermittent-hypoxia-and-exercise-on-cognitive-and-cerebral-function-in-middle-aged-adults-100583289",false,"NCT06874387","Investigating the Combined Effects of Intermittent Hypoxia and Exercise on Cognitive and Cerebral Function in Middle-Aged Adults","Towards a Better Understanding of the Combination of Intermittent Hypoxia and Physical Exercise: Comparison of Effects on Cognitive and Cerebral Capacities in Middle-Aged Adults","HYPOX-AGE","* Inclusion Criteria:\n\n  * Adults aged 50 to 65 years (male and female)\n  * Montreal Cognitive Assessment (MoCA) score ≥ 24\n  * No participation in any structured exercise intervention in the last 6 months\n  * No exposure to altitudes above 1,500 m in the preceding 3 months\n  * No chronic kidney, cardiovascular, metabolic, neurological, or orthopedic -disease\n  * No history of significant respiratory conditions (e.g., asthma, exercise-induced -bronchospasm, dyspnea on exertion)\n  * No current immunosuppressive treatment (e.g., corticosteroids, antidepressants)\n  * No history of cancer or arthritis treatments\n  * No recent blood donation (within the last 2 months)\n  * Must be covered by a Social Security system or equivalent\n  * Signed informed consent after receiving clear and transparent study information\n  * Eligibility confirmed by a medical doctor during the inclusion process\n* Exclusion Criteria:\n\n  * Active smoking\n  * Major cardiovascular complications within the last 3 months (e.g., myocardial i-infarction, unstable angina, severe arrhythmias)\n  * Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic)\n  * Chronic respiratory insufficiency (e.g., COPD, sleep apnea)\n  * Diabetes mellitus\n  * Need for continuous or intermittent oxygen therapy\n  * Participation in another clinical study at the same time\n  * Use of corticosteroids or other systemic immunosuppressants\n  * Any condition compromising safety or study compliance, as determined by the medical team\n  * Pregnancy or breastfeeding\n  * Legal or administrative protections (e.g., individuals under guardianship, persons deprived of liberty)\n  * High baseline physical activity levels (PASE score \\>90 indicating moderate-to-intense physical activity)",true,"ALL","50 Years","65 Years",{"count":81,"type":82},176,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.",[88,89,90],"Cognitive Ability, General","Brain Health","Cerebral Oxygenation",[92,93,94,95,96,89,97,98,99,100,101],"intermittent Hypoxia Training","Hypoxic Conditioning","Physical Activity","Exercise Intervention","Cognitive Function","Non-Pharmacological Interventions","Middle-Aged Adults","Healthy Aging","Cognitive Decline Prevention","Neuroplasticity","NOT_YET_RECRUITING","2025-03-07",{"date":105,"type":106},"2025-03-13","ACTUAL",{"date":108,"type":82},"2025-04-01",{"date":110,"type":82},"2026-12-30",{"name":61,"class":6}]