- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714813
Circuit Training and Retina
Circuit Resistance Training and Retinal Vascular Changes in Older Persons
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Coral Gables, Florida, United States, 33146-2416
- Laboratory of Neuromuscular Research and Active Aging
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Coral Gables, Florida, United States, 33147
- Laboratory of Neuromuscular Research and Active Aging
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65-90 years of age;
- Montreal Cognitive Assessment (MoCA) > 23
- no memory loss complaints
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-Speed Circuit Resistance Training Group
Participants 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.
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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.
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OTHER: Control Group
Participants in this arm will receive two lectures on fitness, diet, or cognition each month for 24 weeks for a total of 12 lectures.
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Lectures on diet, exercise, and cognition.
Lectures will be provided in person or online and will last approximately one hour.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in retinal vessel density as measured by Optical Coherence Tomography Angiography (OCTA)
Time Frame: Baseline, 24 weeks
|
OCTA uses a special camera system and software to measure the densities of the small vessels (microvasculature) of the retinal layers of the eye.
|
Baseline, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Event Memory as measured by the Picture Sequence Memory Test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in Information Sorting as measured by the NIH List Sorting Test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in Reaction Time for a Mental Task as measured by the NIH Pattern Comparison Processing Speed Test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in Dynamic Balance as measured by the Timed Up-and-Go test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in the Ability to perform Daily Activities as measured by the Physical Performance Test
Time Frame: Baseline, 24 weeks
|
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.
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Baseline, 24 weeks
|
Change in Recall and Recognition as measured by the Hopkins Verbal Learning Test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in Dual Tasking ability as measured by the Trail Making Test
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in cardiovascular fitness as measured by the Six-minute walk test.
Time Frame: Baseline, 24 weeks
|
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.
|
Baseline, 24 weeks
|
Change in neuromuscular performance as measured by 1-repetition maximum (1RM)
Time Frame: Baseline, 24 weeks
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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. |
Baseline, 24 weeks
|
Change in Concept Switching as measured by the Dimensional Card Sort test.
Time Frame: Baseline, 24 weeks
|
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.
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Baseline, 24 weeks
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Change in Congruent and Incongruent Responses as measured by the Flanker test
Time Frame: Baseline, 24 weeks
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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.
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Baseline, 24 weeks
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Change in neuromuscular performance as measured by power production.
Time Frame: Baseline, 24 weeks
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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.
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Baseline, 24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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