Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

NCT ID: NCT06986096

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Aerobic-strength training and nutritional counseling

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

Group Type: EXPERIMENTAL

Aerobic-strength training and nutritional counseling

Intervention Type: BEHAVIORAL

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.

Cognitive training and stretching.

Elderly volunteers participating in cognitive training combined with stretching training.

Group Type: EXPERIMENTAL

Cognitive training and stretching.

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Cognitive training and stretching.

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Barbara Ukropcová, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbora Ukropcova, Prof.

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center Slovak Academy of Science

Locations

Biomedical Research Center Slovak Academy of Sciences

Bratislava, Bratislava Region, Slovakia

Site Status: RECRUITING

Countries

Slovakia

Central Contacts

Barbora Ukropcova, Prof.

Role: CONTACT

barbara.ukropcova@sabva.sk

+421911643630

Facility Contacts

Barbara Ukropcova, Prof.

Role: primary

barbara.ukropcova@savba.sk

+421911643630

Other Identifiers

101087124

Identifier Type: -

Identifier Source: org_study_id