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Cognitive Impairment, ProgressiveNCT05714813

Circuit Training and Retina

A study testing High-Speed Circuit Resistance Training and Lecture on Diet, Exercise and Cognition in people with Cognitive Impairment, Progressive and Cerebral Small Vessel Diseases, run by University of Miami at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to see if high-speed weight training performed in a circuit (using one machine after another) can improve participant heart and brain function, strength, and power in older persons. Read more about this study

Who is it for?
Ages 65 to 90 yearsHealthy volunteers can take part
What is being tested?
High-Speed Circuit Resistance Training and Lecture on Diet, Exercise and Cognition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
1 Sep 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65-90 years of age;
  • Montreal Cognitive Assessment (MoCA) > 23
  • no memory loss complaints

Who cannot join

  • Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
  • Cerebrovascular disease;
  • Malignancy within the previous 5 years;
  • Documented HIV infection or other immunodeficiency syndrome;
  • Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
  • A history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
  • Bilateral moderate or severe cataracts;
  • Refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Laboratory of Neuromuscular Research and Active Aging

    Coral Gables, Florida, 33146-2416

  • Laboratory of Neuromuscular Research and Active Aging

    Coral Gables, Florida, 33147

Other trials in United States

About this study

Official title: Circuit Resistance Training and Retinal Vascular Changes in Older Persons

The purpose of this research study is to see if high-speed weight training performed in a circuit (using one machine after another) can improve participant heart and brain function, strength, and power in older persons.

Being tested
High-Speed Circuit Resistance Training, Lecture on Diet, Exercise and Cognition
Keywords
Circuit Resistance Training, High-velocity Training, Retinal Microvasculature, Cognitive Function
Medical subject headings
Cognitive Dysfunction, Cerebral Small Vessel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Speed Circuit Resistance TrainingBehavioural

    Performance of 24 weeks of high-speed concentric and low-speed eccentric lift across three circuits on eleven pneumatic machines. Each training session will be in person and will last between 45 minutes and one hour.

  • Lecture on Diet, Exercise and CognitionBehavioural

    Lectures on diet, exercise, and cognition. Lectures will be provided in person or online and will last approximately one hour.

Study groups in NCT05714813
Study groupRoleWhat they receive
High-Speed Circuit Resistance Training GroupExperimentalParticipants in this group will receive high-speed circuit resistance training 3 times a week for 24 consecutive weeks for a total of 72 training sessions.
Receives: Behavioral: High-Speed Circuit Resistance Training
Control GroupOtherParticipants in this arm will receive two lectures on fitness, diet, or cognition each month for 24 weeks for a total of 12 lectures.
Receives: Behavioral: Lecture on Diet, Exercise and Cognition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in retinal vessel density as measured by Optical Coherence Tomography Angiography (OCTA)

    OCTA uses a special camera system and software to measure the densities of the small vessels (microvasculature) of the retinal layers of the eye.

    Measured: Baseline, 24 weeks

Secondary outcomes (12)
  1. Change in Event Memory as measured by the Picture Sequence Memory Test

    The Picture Sequence Memory Test (PSMT) can test how well a subject can remember events. The participants are asked to recall the sequence of pictures presented over two learning trials. Participants are given credit for each adjacent pair of pictures they correctly put in place. The minimum score is 0 and the maximum score is 17. The higher the score indicates better sequential memory. The test takes approximately seven minutes to administer.

    Measured: Baseline, 24 weeks

  2. Change in Information Sorting as measured by the NIH List Sorting Test

    The National Institute of Health (NIH) List Sorting Test measures a person's ability to store information for a short time while doing other tasks. It asks the subject to sort and put in order lists of both sounds and pictures. The lists may include animals to be sorted by size, foods to be sorted by size, or a combination of the two to be sorted by size. The minimum score is 0 and the maximum score is 26. A higher score indicates better working memory. The test takes about 7 minutes.

    Measured: Baseline, 24 weeks

  3. Change in Reaction Time for a Mental Task as measured by the NIH Pattern Comparison Processing Speed Test

    The Pattern Comparison test measures the subject's reaction time and how long it takes the subject to do a mental task. During the test, the subject will be asked to decide whether two visual patterns are the "same" or "not the same." The minimum score is 0 and the maximum score is 130. A higher score indicates better processing speed. The test takes 85 seconds.

    Measured: Baseline, 24 weeks

  4. Change in Dynamic Balance as measured by the Timed Up-and-Go test

    The Timed Up and Go test (TUG) measures dynamic balance, leg strength and walking speed. For this test the subject will sit back in a chair with the hands in the lap. On go, the subject will get up, walk around a cone that is about 9 feet from the chair, walk back and sit back down. The subject will have one practice trial and two real trials. Healthy individuals between 60 and 80 years of age are expected to complete the TUG in 10 seconds or less. Lower scores indicate a better performance.

    Measured: Baseline, 24 weeks

  5. Change in the Ability to perform Daily Activities as measured by the Physical Performance Test

    The Physical Performance Test tests daily skills. The subject is asked to write a sentence, pick up some beans from a table and put them in a coffee can, move a book from a table to a shoulder-high shelf, put on and take off a coat, pick up a penny from the floor, turn around 360 degrees, walk 50 feet, and climb up and down some flights of stairs. The minimum score is 0 and the maximum score is 36. A higher score indicates better ability to do daily activities. The test takes about 5 minutes.

    Measured: Baseline, 24 weeks

  6. Change in Recall and Recognition as measured by the Hopkins Verbal Learning Test

    The Hopkins Verbal Learning Test is a brief assessment of immediate recall, delayed recall and delayed recognition commonly used with populations with Alzheimer's disease, Huntington's disease and amnesic disorders. The maximum score for the test is 36 with scores below 14, indicating dementia. The minimum score is 0 and the maximum score is 36. A higher score indicates better working memory. The test takes about 5-10 minutes to take.

    Measured: Baseline, 24 weeks

  7. Change in Dual Tasking ability as measured by the Trail Making Test

    The Trail Making Test (TMT) is commonly used to screen for dementia by assessing the ability to think, reason, and remember. The score is how long it takes to complete the test. There is no minimal score, and the maximum score is 5 minutes. A lower the score the better the ability to reason and remember. The test takes about 7 minutes.

    Measured: Baseline, 24 weeks

  8. Change in cardiovascular fitness as measured by the Six-minute walk test.

    The six-minute walk test requires the subject to walk as far as possible in six minutes. The score is the distance traveled. The minimal score would be 0 and there is no maximum score. The further a person walks the better the cardiovascular condition. The test takes 6 minutes.

    Measured: Baseline, 24 weeks

  9. Change in neuromuscular performance as measured by 1-repetition maximum (1RM)

    Maximal load that can be lifted in one repetition (1RM) will be assessed for in both leg press and chest press exercises. The loads on the testing equipment will be increased over 5 to 7 testing sets. The persons 1RM will be the highest load the person can move through the range of motion of the exercise. There are no minimum or maximum scores for this test.

    The test typically takes 5 to 10 minutes. The higher the 1RM the stronger the person is.

    Measured: Baseline, 24 weeks

  10. Change in Concept Switching as measured by the Dimensional Card Sort test.

    The Dimensional Change Card Sort test is a measure of cognitive flexibility. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). "Switch" trials are also employed, in which the participant must change the dimension being matched. Scoring is based on a combination of accuracy and reaction time. Scores can range from 0-10. The higher the score, the better the capacity to switch from one concept to another. The test typically lasts four minutes.

    Measured: Baseline, 24 weeks

  11. Change in Congruent and Incongruent Responses as measured by the Flanker test

    The Flanker Test uses response inhibition to assess a subject's capacity to suppress incorrect responses within a particular context. The target (for this study an arrow) is flanked by non-target arrows that are either in the same direction as the target (congruent flankers), the opposite response (incongruent flankers), or to neither (neutral flankers). The minimum score is 0 and the maximum score is 10. A higher score indicates better accuracy. The test takes about 3 minutes.

    Measured: Baseline, 24 weeks

  12. Change in neuromuscular performance as measured by power production.

    This test measures the power a person can produce at maximal speed using a load of 50% of 1RM for the chest press and leg press. There are no minimum or maximum scores. The higher score is better. Power shows how fast a person can do work. The test typically takes about five minutes.

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start1 Sep 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714813
Sponsor's protocol ID
20210271
Status last verified
Jan 2023
First submitted
21 Dec 2022
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Speed Circuit Resistance Training and Lecture on Diet, Exercise and Cognition in people with Cognitive Impairment, Progressive and Cerebral Small Vessel Diseases, run by University of Miami at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in retinal vessel density as measured by Optical Coherence Tomography Angiography (OCTA) (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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