NCT05232968

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2022

Enrollment Period

3.9 years

First QC Date

January 14, 2022

Last Update Submit

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

EXPERIMENTAL

Elderly 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.

Other: Long-term exercise program

Elderly sedentary volunteers

NO INTERVENTION

Control 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

EXPERIMENTAL

Elderly volunteers will follow 4-month of aerobic-strength training intervention and exercise induced effects on mild cognitive impairment will be determined afterwards.

Other: Short-term exercise program

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).

Elderly volunteers participating in the 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).

Elderly volunteers participating in the short-term exercise program

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Biomedical Research Center Slovak Academy of Sciences

Bratislava, 84505, Slovakia

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Barbora Ukropcova, Prof.

    Biomedical Research Center Slovak Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora Ukropcova, Prof.

CONTACT

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

All IPD that underlie results in a publication

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.

Locations