Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
Recruiting · NCT06986096 · Interventional (participants receive a specific treatment) · Lead sponsor: Slovak Academy of Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Aerobic-strength training and nutritional counselingCognitive training and stretching.
What this trial is about
Due to the increasing incidence of dementia and the lack of causal treatment, non-pharmacological interventions represent an attractive and effective therapeutic strategy of neurodegenerative diseases, such as Alzheimer's disease. The aim of the study is to assess the impact of a supervised 9-month intervention with aerobic-strength training and nutritional counseling compared to cognitive training and stretching on the brain, cognitive and motor functions, metabolism, physical fitnes and plasma markers of neurodegenertion in older adults at increased risk of developing Alzheimer's disease.
Who can take part
Age range
60 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Non-smokers
- Signed informed consent
- Presence of subjective or mild cognitive impairment (SCI/aMCI)
- Elevated levels of selected biomarkers confirming the presence of a pathological process characteristic of Alzheimer's disease
- Absence of any psychological, sociological, or geographical factors that could jeopardize participation in the project.
Exclusion criteria
- Presence of severe cardiovascular, liver, or kidney diseases; advanced or poorly controlled diabetes mellitus (HbA1c \>7%), treated with insulin or incretin analogs; cancer or any other severe disease as assessed by the responsible physician. A history of cancer treated with chemotherapy or radiotherapy if within less than 5 years post-treatment.
- Lack of cooperation, inflexible schedule, or problematic transportation.
- Insufficient functional capacity or presence of comorbidities that prevent participation in the training program (assessment by an internist, cardiologist, neurologist, orthopedic specialist, or other relevant specialists).
- Presence of a pacemaker or any metal implants (contraindication for MRI examination), or allergy to local anesthetics (contraindication for muscle biopsy).
- Smoking, alcohol dependence, or addiction to other narcotic substances.
- Stroke or myocardial infarction within the last year.
- Long-term treatment for psychiatric disorders - a depressive syndrome is not an exclusion criterion if it is compensated by therapy.
- Other diseases of the musculoskeletal or nervous system that potentially interfere with the ability to exercise or cognition - such as severe arthritis, Parkinson's disease, significant essential tremor, epilepsy, etc.
- Concurrent participation in another clinical study.
- Therapy with cholinesterase inhibitors unless the patient is on a stable dose.
Where it is running
1 location listed.
- Biomedical Research Center Slovak Academy of Sciences - Bratislava, Bratislava Region, Slovakia