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.
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
- Conditions the study is for
- Cognitive Impairment, Progressive, Cerebral Small Vessel Diseases
- What is being tested?
- High-Speed Circuit Resistance Training and Lecture on Diet, Exercise and Cognition
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| High-Speed Circuit Resistance Training Group | Experimental | 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. Receives: Behavioral: High-Speed Circuit Resistance Training |
| Control Group | Other | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted6 Feb 2023
- Study start1 Sep 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F Signorile, PhD, Principal investigator, University of Miami
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit Resistance Training and Retinal Vascular Changes in Older Persons
- ClinicalTrials.gov ID
- NCT05714813
- Acronym / sponsor ID
- 20210271
- Keywords
- Circuit Resistance Training, High-velocity Training, Retinal Microvasculature, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Speed Circuit Resistance Training Group | Experimental | Behavioral: High-Speed Circuit Resistance TrainingParticipants 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. |
| Control Group | Other | Behavioral: Lecture on Diet, Exercise and CognitionParticipants in this arm will receive two lectures on fitness, diet, or cognition each month for 24 weeks for a total of 12 lectures. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65-90 years of age;
- Montreal Cognitive Assessment (MoCA) > 23
- no memory loss complaints
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Speed Circuit Resistance TrainingPerformance 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. | Behavioural | High-Speed Circuit Resistance Training Group |
| Lecture on Diet, Exercise and CognitionLectures on diet, exercise, and cognition. Lectures will be provided in person or online and will last approximately one hour. | Behavioural | Control Group |
Primary outcome
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.
12 secondary outcomes
Change in Event Memory as measured by the Picture Sequence Memory Test
Time frame: Baseline, 24 weeks
Change in Information Sorting as measured by the NIH List Sorting Test
Time frame: 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
Change in Dynamic Balance as measured by the Timed Up-and-Go test
Time frame: Baseline, 24 weeks
Change in the Ability to perform Daily Activities as measured by the Physical Performance Test
Time frame: Baseline, 24 weeks
Change in Recall and Recognition as measured by the Hopkins Verbal Learning Test
Time frame: Baseline, 24 weeks
Change in Dual Tasking ability as measured by the Trail Making Test
Time frame: Baseline, 24 weeks
Change in cardiovascular fitness as measured by the Six-minute walk test.
Time frame: Baseline, 24 weeks
Change in neuromuscular performance as measured by 1-repetition maximum (1RM)
Time frame: Baseline, 24 weeks
Change in Concept Switching as measured by the Dimensional Card Sort test.
Time frame: Baseline, 24 weeks
Change in Congruent and Incongruent Responses as measured by the Flanker test
Time frame: Baseline, 24 weeks
Change in neuromuscular performance as measured by power production.
Time frame: Baseline, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph F Signorile, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
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.