CClinicalTrials.gg
CompletedNCT06588842Updated Mar 3, 2025

Cluster Resistance Training and Older Adults

An interventional study of Cluster Set Resistance Training and Traditional Set Resistance Training in Healthy Aging, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

This project will focus on improving power in older adults, since power is related to performance of daily activities and memory and decision making. The study will compare cluster set resistance training, where you can rest during a set, to traditional set resistance training where all repetitions in a set must be completed without any between-repetition rest. If cluster set resistance training is better than traditional set resistance training, it could be more beneficial than existing methods in improving independence in older persons.

02

Conditions studied

  • Healthy Aging

Keywords

  • Resistance Training
03

In context

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Montreal Cognitive Assessment Score > 23
  • No memory complaints

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Cluster Set Resistance Training

    Participants in this group will receive high-speed resistance training 2 times a week for 12 consecutive weeks.

    Other: Cluster Set Resistance Training

  • Active comparator
    Traditional Set Resistance Training

    Participants in this group will receive traditional set resistance training 2 times a week for 12 consecutive weeks.

    Other: Traditional Set Resistance Training

Interventions

  • OtherCluster Set Resistance Training

    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.

  • OtherTraditional Set Resistance Training

    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.

06

What researchers measure

Primary outcomes

  1. 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. Unit of measure is Watts.

    Time frame: Baseline, 12 weeks

  2. 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.

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA)

    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.

    Time frame: Baseline, 12 weeks

  2. Change in 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.

    Time frame: Baseline, 12 weeks

  3. 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). 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.

    Time frame: Baseline, 12 weeks

  4. Change in 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.

    Time frame: Baseline, 12 weeks

  5. 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.

    Time frame: Baseline, 12 weeks

  6. 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.

    Time frame: Baseline, 12 weeks

  7. 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.

    Time frame: Baseline, 12 weeks

  8. Change in Mental Task as measured by Trail Making Test

    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.

    Time frame: Baseline, 12 weeks

  9. Change in the Speed of the Ten-Meter Walk Test

    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.

    Time frame: Baseline, 12 weeks

  10. Change in Time for the Five Times Sit-to-Stand Test

    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.

    Time frame: Baseline, 12 weeks

  11. Change in Distance of the Seated Medicine Ball Throw

    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.

    Time frame: Baseline, 12 weeks

  12. Change in the time required to complete the timed Up-and-Go Test.

    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.

    Time frame: Baseline, 12 weeks

  13. Change in Muscle Thickness using Ultrasound

    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

    Time frame: Baseline, 12 weeks

  14. Change in Muscle Quality using Ultrasound

    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.

    Time frame: Baseline, 12 weeks

07

Study locations

1 site
  • Laboratory of Neruomuscular Research and Active Aging
    Coral Gables, Florida 33147, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06588842
Lead sponsor
University of Miami
Responsible party
Joseph Signorile (Professor, University of Miami) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
Mar 3, 2025

Study contacts

Joseph F. Signorile, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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