Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Impact on Cognitive Functions [Срок оценки: Measurements at the baseline and after 9-month intervention.]
• Effect of Interventions on Neurodegeneration Markers [Срок оценки: Measurements at the baseline and after 9-month intervention]

Вторичные конечные точки (7)

• Computerized Cognitive Tests [Срок оценки: Measurements at the baseline and after 9-month intervention.]
• Well-being [Срок оценки: Measurements at the baseline and after 9-month intervention.]
• Glucose metabolism [Срок оценки: Measurements at the baseline and after 9-month intervention.]
• MRI of the Brain [Срок оценки: Measurements at the baseline and after 9-month intervention.]
• Adherence [Срок оценки: Adherence will be recorded during the 9-month intervention period.]
• Olfactory Function [Срок оценки: Measurements at baseline and after 9-month intervention.]
• Microbiome Composition [Срок оценки: Measurements at baseline and after 9-month intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Словакия · 1 центр

• Biomedical Research Center Slovak Academy of Sciences — Bratislava

Идентификаторы

NCT: NCT06986096 · 101087124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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