Circuit Training and Retina

Cerebral Small Vessel Diseases Clinical Trial

Official title:

Circuit Resistance Training and Retinal Vascular Changes in Older Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714813
• Other study ID #: 20210271
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 65-90 years of age;

2. Montreal Cognitive Assessment (MoCA) > 23

3. no memory loss complaints

Exclusion Criteria:

1. Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;

2. Cerebrovascular disease;

3. Malignancy within the previous 5 years;

4. Documented HIV infection or other immunodeficiency syndrome;

5. Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;

6. A history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;

7. Bilateral moderate or severe cataracts;

8. Refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Behavioral:
• High-Speed Circuit Resistance Training
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 Cognition
Lectures on diet, exercise, and cognition. Lectures will be provided in person or online and will last approximately one hour.

Locations

Country	Name	City	State
United States	Laboratory of Neuromuscular Research and Active Aging	Coral Gables	Florida
United States	Laboratory of Neuromuscular Research and Active Aging	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks
Secondary	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.	Baseline, 24 weeks