Ameliorating Effects of Aging by Physical Exercise

Aging Clinical Trial

— AMETHYST  

Official title:

Ameliorating Effects of Aging by Physical Exercise: Molecular, Metabolic and Structural Adaptations, Multi-organ Integrative Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232968
• Other study ID #: APVV-20-0466
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: Slovak Academy of Sciences
• Contact: Barbora Ukropcova, Prof.
• Phone: +421911643630
• Email: barbara.ukropcova[@]sabva.sk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This interventional study will examine the effects of a comprehensive intervention associated with regular short-term (4 months) and long-term (≥2 years) exercise on the cognitive and motor functions of patients with mild cognitive impairment, as well as the effect of aging, physical activity profile and physical fitness on physiological functions (metabolism, motor skills, cognition) and bioactive molecules. The study will be carried out in the Department of Internal Medicine and in the Center for Physical Activity Research of the Biomedical Center of the Slovak Academy of Sciences in Bratislava. Recruitment and screening of seniors with MCI will be carried out by psychologists from the Memory Center in Bratislava (http://www.centrummemory.sk/) and neurologists from II. Department of Neurology LFUK and UNB. All volunteers will be informed in detail about the objectives of the study, the examinations and study protocol, the benefits as well as the potential risks associated with its completion and will sign an informed consent. The study protocol is approved by the ethics committee of the Bratislava. The project aims to study the effects and mechanisms of the positive impact of regular physical activity and increased physical fitness on health and processes associated with aging, with emphasis on metabolic, cognitive and motor functions, physical fitness and bioactive molecules in the circulation and skeletal muscle. It therefore has real potential to reveal new physiologically important mechanisms, biomarkers or even potential molecular targets for the therapy of neurodegenerative and metabolic diseases. One of the important goals of the project is the implementation of the obtained results into clinical practice, in cooperation with clinicians, psychologists, trainers and special educators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• 55-85 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Aging
• Exercise

Intervention

Other:
• Long-term exercise program
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).
• Short-term exercise program
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).

Locations

Country	Name	City	State
Slovakia	Biomedical Research Center Slovak Academy of Sciences	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
Slovak Academy of Sciences	Medical University of Vienna

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal aerobic capacity	Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).	4 months
Primary	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
Primary	Depressive symptoms	All participants will receive Beck depression questionnaire to identify depressive symptoms.	4 months
Primary	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
Primary	Brain volumetry (MRI)	Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).	4 months
Primary	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