Ameliorating Effects of Aging by Physical Exercise
AMETHYST
1 other identifier
interventional
120
1 country
1
Brief Summary
With increasing longevity, a significant increase in the incidence of neurodegenerative diseases is expected. According to forecasts based on data from the World Health Organization and data from epidemiological studies, up to 106 million people will have Alzheimer's disease in 2050, it's 1 in 85 people living on the planet. If it will be possible to manage to delay the onset or slow the progression of the disease by a single year, it will mean 9.2 million fewer patients worldwide. This leaves considerable scope for options to modify the onset and prevalence of the disease through lifestyle changes such as eating habits and exercise. It is known that the human brain retains a certain natural plasticity even in old age, which is a great advantage that allows it to adapt to physiological stimuli, such as regular exercise. The pleiotropic beneficial effects of exercise therefore have considerable potential to be used in the prevention and slowing of the progression of cognitive and motor function decline as well as in the prevention / treatment of metabolic dysregulation. This fact is supported by many epidemiological and interventional studies with exercise, emphasizing the importance of the global trend to use exercise as a standardized method of prevention and treatment of many chronic diseases and cognitive deficits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2022
CompletedFirst Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 10, 2022
February 1, 2022
3.9 years
January 14, 2022
February 9, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Maximal aerobic capacity
Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).
4 months
Cognitive function testing
All participants will receive extensive psychological testing (Montreal Cognitive Assessment), assessing cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation.
4 months
Depressive symptoms
All participants will receive Beck depression questionnaire to identify depressive symptoms.
4 months
Olfactory function
The sense of smell will be investigated using the extended "Sniffing' Sticks" test battery, standardized and reliable test used to measure odor thresholds, discrimination \& identification.
4 months
Brain volumetry (MRI)
Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).
4 months
Molecular genetic analyses
Gene expression will be measured with the aid of qRT-PCR using TaqMan® Gene Expression Assays on the ABI 7900HT (Applied Biosystems, USA).
4 months
Study Arms (3)
Elderly volunteers participating in the long-term exercise program
EXPERIMENTALElderly volunteers will be recruited from participants in the long-term exercise program (ongoing since 2017) at the Center of Physical Activity BMC SAS in Bratislava.
Elderly sedentary volunteers
NO INTERVENTIONControl population will be recruited from the sedentary elderly, who dropped out from the exercise program ≥2 years prior entering this study and do not exercise on regular basis.
Elderly volunteers participating in the short-term exercise program
EXPERIMENTALElderly volunteers will follow 4-month of aerobic-strength training intervention and exercise induced effects on mild cognitive impairment will be determined afterwards.
Interventions
Training intervention (aerobic-strength training) will combine a 1-hour aerobics training, which requires movement coordination, and two 1-hour lessons, combining strength load (25 minutes, 50-60% 1RM, which gradually increases in proportion to increasing strength, 8-12 repetitions, training all major muscle groups) and aerobic exercise (25 minutes of Nordic walking or stationary bike), with a short warm-up at the beginning and stretching at the end. The individualized training program will be based on the determination of physical fitness (Rockport gait test) and muscle strength (dynamometry).
Training intervention (aerobic-strength training) will combine a 1-hour aerobics training, which requires movement coordination, and two 1-hour lessons, combining strength load (25 minutes, 50-60% 1RM, which gradually increases in proportion to increasing strength, 8-12 repetitions, training all major muscle groups) and aerobic exercise (25 minutes of Nordic walking or stationary bike), with a short warm-up at the beginning and stretching at the end. The individualized training program will be based on the determination of physical fitness (Rockport gait test) and muscle strength (dynamometry).
Eligibility Criteria
You may qualify if:
- years of age,
- non-smokers
- complete vaccination against COVID19
- continuation in the supervised exercise program (for study of long-term effects of exercise experimental group)
- sedentary lifestyle ≥2 years prior this study (for group without intervention),
- mild cognitive impairment (for study of short-term effects of exercise experimental group)
- absence of any psychological, sociological or geographical factor that could jeopardize participation in the project.
You may not qualify if:
- any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor);
- no cooperation of probands;
- insufficient functional capacity - the presence comorbidities or disorders of the musculoskeletal system, which makes it impossible to complete the training program (assessment by cardiologist, or orthopedist or other specialist);
- smoking, alcohol or drugs abuse;
- non-compliance with epidemiological measures;
- absence of complete vaccination with SARS-CoV-2 vaccine;
- presence of a pacemaker or metal implants (contraindication for magnetic resonance imaging).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Slovak Academy of Scienceslead
- Medical University of Viennacollaborator
Study Sites (1)
Biomedical Research Center Slovak Academy of Sciences
Bratislava, 84505, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbora Ukropcova, Prof.
Biomedical Research Center Slovak Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 14, 2022
First Posted
February 10, 2022
Study Start
January 10, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 31.12.2025 indefinitely
- Access Criteria
- In principle to all researchers working in the area. Requests will be reviewed by Prof. Barbara Ukropcova.
All IPD that underlie results in a publication