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The effectiveness and safety of high-intensity interval training, yoga and intermittent hypoxia-hyperoxia exposure on cognitive performance and health in individuals with mild cognitive impairment: a randomized, sham-controlled trial

The effectiveness and safety of high-intensity interval training, yoga and intermittent hypoxia-hyperoxia exposure on cognitive performance and health in individuals with mild cognitive impairment: a randomized, sham-controlled trial - KAYH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038438
Enrollment
100
Registered
2025-12-04
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F06.7

Interventions

Group 1: High-intensity interval training (HIIT): Participants in the HIIT group perform HIIT twice a week for 12 weeks using a cycle ergometer. Their individual training parameters will be determined

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: - MCI (classification according to DemTect 8 [cut-off for no dementia]) - Physical condition that permits the use of a cycle ergometer and participation in the interventions - Sufficient time availability (e.g. assessments, intervention) - Adequate language, visual, and hearing ability for completion of self-reported and interviewer-administered assessment instruments - Ability to travel to the study center - Age = 60 years - Provision of informed consent and willingness to participate in the study

Exclusion criteria

Exclusion criteria: - Severe psychiatric and neurological disorders (e.g., Parkinson’s disease, Huntington’s disease, schizophrenia, bipolar disorder, cerebrovascular disease with acute stroke or cerebral hemorrhage within the past 6 months) - Congenital or acquired cardiac and major vascular malformations - Renal failure - Diagnosed dementia - Comorbidities that contraindicate physical exercise, HIIT, Yoga or IHHE (e.g., untreated hypertension, coronary artery disease with unstable angina pectoris [Canadian Cardiovascular Society, CCS grade 3–4], heart failure [New York Heart Association, NYHA class II–IV], myocardial infarction within the past 3 months, pulmonary fibrosis, chronic obstructive pulmonary disease [GOLD stage II, FEV1 1,500 m above sea level within the past 4 weeks - Current yoga practice - = 150 minutes of moderate or = 75 minutes of vigorous physical activity per week (excluding daily activity for transportation purposes) - Concurrent participation in another clinical intervention study

Design outcomes

Primary

MeasureTime frame
Cognitive function measured by Montreal Cognitive Assessment (MoCA) at baseline (t0) and after 3 months intervention (t1).

Secondary

MeasureTime frame
Secondary outcomes at baseline (t0) and after 3 months of intervention (t1) include: - physical activity (European Health Interview Survey – Physical Activity Questionnaire, EHIS-PAQ) - sleep quality (Pittsburgh Sleep Quality Index, PSQI [46]) - health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L) - depressive symptoms (Patient Health Questionnaire-9, PHQ-9) - loneliness and social isolation (UCLA Loneliness Scale, UCLA-LS) - diabetes risk (Diabetes Risk Test, DRT) - visual attention and executive function (Trail Making Test A & B, TMT) - anthropometric data (body weight, BMI, waist and hip circumference), - body composition (bioelectrical impedance analysis parameters including fat mass, fat-free mass, reactance, resistance, and phase angle) - cardiovascular markers (resting heart rate, systolic and diastolic blood pressure, and the ankle-brachial index) - laboratory markers (HbA1c, LDL/HDL, total cholesterol, triglycerides, CRP) - physiological outcomes (VO2peak, ventilatory thresholds VT1 and VT2, peak power output, maximum heart rate, blood lactate, and blood gases) - safety and feasibility of the interventions In addition, MoCA and patient-reported secondary outcomes will be assessed after 9 months follow-up (t2).

Countries

Germany

Contacts

Public ContactHolger Cramer

Universitätsklinikum Tübingen, Institut für Allgemeinmedizin und Interprofessionelle Versorgung

holger.cramer@med.uni-tuebingen.de+49711 8101 7860

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026