RecruitingNot ApplicableNCT06986096

Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET


Sponsor

Slovak Academy of Sciences

Enrollment

40 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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.

Interventions

BEHAVIORALAerobic-strength training and nutritional counseling

The intervention consists of a structured program that includes aerobic-strength training (1h training, 3 times per week) conducted by professional trainers combined with nutritional counseling.

BEHAVIORALCognitive training and stretching.

The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).


Locations(1)

Biomedical Research Center Slovak Academy of Sciences

Bratislava, Bratislava Region, Slovakia

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NCT06986096


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