Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

NCT06986096 | Recruiting

• 1 other identifier: 101087124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Impact on Cognitive Functions

  Overall composite score of neuropsychological testing batery (higher score better outcome)

  Measurements at the baseline and after 9-month intervention.

• Effect of Interventions on Neurodegeneration Markers

  Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).

  Measurements at the baseline and after 9-month intervention

Secondary Outcomes (7)

• Computerized Cognitive Tests

  Measurements at the baseline and after 9-month intervention.

• Well-being

  Measurements at the baseline and after 9-month intervention.

• Glucose metabolism

  Measurements at the baseline and after 9-month intervention.

• MRI of the Brain

  Measurements at the baseline and after 9-month intervention.

• Adherence

  Adherence will be recorded during the 9-month intervention period.

Study Arms (2)

Aerobic-strength training and nutritional counseling

EXPERIMENTAL

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

Behavioral: Aerobic-strength training and nutritional counseling

Cognitive training and stretching.

EXPERIMENTAL

Elderly volunteers participating in cognitive training combined with stretching training.

Behavioral: Cognitive training and stretching.

Interventions

Aerobic-strength training and nutritional counseling 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.

Aerobic-strength training and nutritional counseling

Cognitive training and stretching. BEHAVIORAL

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

Cognitive training and stretching.

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Slovak Academy of Sciences: lead

Study Sites (1)

Biomedical Research Center Slovak Academy of Sciences

Bratislava, Bratislava Region, 84505, Slovakia

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity; Cognitive Dysfunction

Interventions

Nutrition Assessment; Cognitive Training

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Cognition Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Barbora Ukropcova, Prof.

  Biomedical Research Center Slovak Academy of Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora Ukropcova, Prof.

CONTACT

+421911643630; barbara.ukropcova@sabva.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: ID codes will be provided for the outcomes assessor, without group-specific characterization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: May 22, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)