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

Slovak Academy of Sciences

Status: Enrolling

Conditions: Life Style, Healthy; Aging; Alzheimer Disease; Cognitive Impairment; Exercise

Treatments: Behavioral: Aerobic-strength training and nutritional counseling; Behavioral: Cognitive training and stretching.

Study type: Interventional

Funder types: Other

Identifiers

NCT06986096

101087124

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Aerobic-strength training and nutritional counseling

Experimental group

Description:

Elderly volunteers participating in aerobic-strength training and nutritional counseling.

Treatment:

Behavioral: Aerobic-strength training and nutritional counseling

Cognitive training and stretching.

Experimental group

Description:

Elderly volunteers participating in cognitive training combined with stretching training.

Treatment:

Behavioral: Cognitive training and stretching.