Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorSlovak Academy of Sciences
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic-strength training and nutritional counseling
BehavioralThe 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.
BehavioralThe intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Aerobic-strength training and nutritional counselingExperimental treatment 1 intervention
Group B: Cognitive training and stretching.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Impact on Cognitive Functions
Overall composite score of neuropsychological testing batery (higher score better outcome)
Time frame
Measurements at the baseline and after 9-month intervention.2
Effect of Interventions on Neurodegeneration Markers
Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).
Time frame
Measurements at the baseline and after 9-month interventionSecondary outcomes
1
Computerized Cognitive Tests
Computerised cognitive testing CogState (learning/working memory score, higher score - better outcome)
Time frame
Measurements at the baseline and after 9-month intervention.2
Well-being
The World Health Organization Quality of Life questionaire (WHOQOL-BREF), 31 items, highre score better QoL.
Time frame
Measurements at the baseline and after 9-month intervention.3
Glucose metabolism
oral glucose tolerance test will be perfromed to detect level of glucose intolerance (impaired glucose tolerance)
Time frame
Measurements at the baseline and after 9-month intervention.4
MRI of the Brain
Imaging studies to assess structural adaptation of the brain (hippocampal volume).
Time frame
Measurements at the baseline and after 9-month intervention.Sponsors and contacts
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Source ClinicalTrials.gov