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 (KAYH): a study protocol for a randomized, sham-controlled trial
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Introduction
Individuals diagnosed with mild cognitive impairment (MCI) have an increased risk of developing dementia. Since there are currently no curative pharmacological therapies for MCI, nonpharmacological and exercise-related medical therapies represent a promising approach. This study aims to evaluate the effects of nonpharmacological interventions on cognitive performance in individuals with MCI.
Methods and analysis
The study will be a prospective, randomized, sham-controlled, single-centre superiority trial with a parallel-group design. A total of 100 patients aged ≥ 60 years with MCI will be randomly assigned to one of the three intervention groups or the control group. The three intervention arms comprise high-intensity interval training (HIIT), yoga, and intermittent hypoxia-hyperoxia exposure (IHHE), whereas participants in the control group will receive a sham application of IHHE (IHHE-S). The primary outcome is the cognitive function after 3-month intervention period assessed by Montreal Cognitive Assessment. The secondary outcomes and the evaluation of modifiable risk factors for dementia include quality of life, laboratory data, physical activity, anthropometric data, and cardiorespiratory fitness. All harms and (serious) adverse events will be assessed systematically at each study visit.
Ethics and dissemination
This study has been approved by the Ethics committee of the Medical Faculty of the University of Tübingen (494/2025BO1). Research findings will be published in peer-reviewed journals and presented to stakeholders and at scientific conferences.
Trial registration
The study was registered on the German Clinical Trial Register DRKS on 04.12.2025 (DRKS00038438).
Strengths and limitations of this study
- The randomized, sham-controlled study design represents a key methodological strength, allowing reliable comparisons between the intervention groups and the control group while accounting for potential placebo effects.
- The 12-month follow-up from baseline provides the opportunity to evaluate the long-term effects of the interventions.
- Blinding of participants and therapists cannot be fully implemented across all study groups because of the nature of the interventions.
