- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06588842
Cluster Resistance Training and Older Adults
Cluster Set Resistance Training as a Modality of Power Training in Older Adults
Study Overview
Status
Conditions
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, 33147
- Laboratory of Neruomuscular Research and Active Aging
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Montreal Cognitive Assessment Score > 23
- No memory complaints
Exclusion Criteria:
- Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
- Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, system lupus erythematosus, or other serious concomitant medical illness
- Unresolved injury or surgery to the upper or lower limbs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cluster Set Resistance Training
Participants in this group will receive high-speed resistance training 2 times a week for 12 consecutive weeks.
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Participants will receive a total of 24 in-person training sessions using three sets of eight repetitions per set.
During training participants will be allowed 1-minute rests between sets and 15-second rests after repetitions three and six.
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Active Comparator: Traditional Set Resistance Training
Participants in this group will receive traditional set resistance training 2 times a week for 12 consecutive weeks.
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Participants will receive a total of 24 in-person training sessions using three sets of eight repetitions per set.
During training participants will be allowed 1-minute rests between sets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in neuromuscular performance as measured by power production.
Time Frame: Baseline, 12 weeks
|
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.
Unit of measure is Watts.
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Baseline, 12 weeks
|
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Change in neuromuscular performance as measured by 1-repetition maximum (1RM)
Time Frame: Baseline, 12 weeks
|
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, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, 12 weeks
|
The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment.
The MoCA has 16 items.
If cognitive impairment is detected through this screening questionnaire, subjects will not be included in the research.
The scale has a total score of 30 points.
≥26 points were considered as having no cognitive impairment.
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Baseline, 12 weeks
|
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Change in the Hopkins Verbal Learning Test
Time Frame: Baseline, 12 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.
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Baseline, 12 weeks
|
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Change in Concept Switching as measured by the Dimensional Card Sort test.
Time Frame: Baseline, 12 weeks
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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).
Four 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, 12 weeks
|
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Change in the Flanker test
Time Frame: Baseline, 12 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, 12 weeks
|
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Change in Event Memory as measured by the Picture Sequence Memory Test
Time Frame: Baseline, 12 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.
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Baseline, 12 weeks
|
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Change in Information Sorting as measured by the NIH List Sorting Test
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
|
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Change in Reaction Time for a Mental Task as measured by the NIH Pattern Comparison Processing Speed Test
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change in Mental Task as measured by Trail Making Test
Time Frame: Baseline, 12 weeks
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Used to assess executive function in the areas of visual attention (Part A) and set-shifting (the ability to shift attention between one task and another; Part B).
The time to complete this test is recorded in seconds.
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Baseline, 12 weeks
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Change in the Speed of the Ten-Meter Walk Test
Time Frame: Baseline, 12 weeks
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The ten-meter walk test will be used to assess gait velocity.
The participants will be asked to walk as quickly as possible in a straight line on a 10-m course marked at 0, 2, 8 and 10 m.
On verbal command, participants will start on the 0-m mark and stop when they cross the 10-m mark.
The total time to ambulate from the 2-m mark to the 8-m mark (6 m total) will be timed to the hundredth of a second.
Two trials will be performed, and the average will be documented in meters per second.
One-minute recoveries will be provided between trials.
Total time is 7 minutes.
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Baseline, 12 weeks
|
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Change in Time for the Five Times Sit-to-Stand Test
Time Frame: Baseline, 12 weeks
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The five time sit-to-stand test will be used to assess functional lower body strength.
The participant will sit with their arms folded across their chest and their back against the chair.
On verbal command, the participant will stand up and sit down 5 times as quickly as possible.
Timing begins at "Go" and ends when the buttocks touch the chair after the 5th repetition.
One practice and two testing trials will be performed.
Time will be measured in seconds.
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Baseline, 12 weeks
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Change in Distance of the Seated Medicine Ball Throw
Time Frame: Baseline, 12 weeks
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For the Seated Medicine Ball Throw, subjects will sit in an armless chair with their back against the chair back, while holding the 6-pound medicine ball against their chest.
Subjects will then throw the ball at a perceived 45° angle as far as possible.
Subjects must complete at least three practice trials; however, subjects will be allowed more trials until comfortable with the testing procedure.
Upon starting the official trial, subjects will complete three separate attempts at each varying medicine ball, to nine trials in total.
Each of the three trials within a given medicine ball will be separated by a 1-minute rest.
Distance will be measured in centimeters.
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Baseline, 12 weeks
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Change in the time required to complete the timed Up-and-Go Test.
Time Frame: Baseline, 12 weeks
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Upon verbal cue, the subject stands up, walks around a cone placed three meters from the front edge of the chair, and then returns to a seated position as quickly as possible.
Time is measured in seconds.
The faster the person completes the test the better the dynamic balance.
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Baseline, 12 weeks
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Change in Muscle Thickness using Ultrasound
Time Frame: Baseline, 12 weeks
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Three images will be taken in the longitudinal view in B-mode.
Muscle thickness will be measured by drawing a perpendicular line from the deep to superficial aponeurosis at the thickest region of each muscle.
The unit of measurement is centimeters
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Baseline, 12 weeks
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Change in Muscle Quality using Ultrasound
Time Frame: Baseline, 12 weeks
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Muscle quality will be measured using a gray scale.
The black and white pixels correspond to arbitrary values of 0 (darker) to 255 (lighter), with darker colors indicting more muscle and lighter colors indicating more fat.
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Baseline, 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph F. Signorile, PhD, University of Miami
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
Other Study ID Numbers
- 20240776
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
product manufactured in and exported from the U.S.
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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