Healthy AgingNCT06588842
Cluster Resistance Training and Older Adults
A study testing Cluster Set Resistance Training and Traditional Set Resistance Training in people with Healthy Aging, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Cluster Set Resistance Training and Traditional Set Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 20 Feb 2025
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment Score > 23
- No memory complaints
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: Cluster Set Resistance Training as a Modality of Power Training in Older Adults
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.
- Conditions
- Healthy Aging
- Being tested
- Cluster Set Resistance Training, Traditional Set Resistance Training
- Keywords
- Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cluster Set Resistance TrainingOther
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.
Traditional Set Resistance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster Set Resistance Training | Experimental | Participants in this group will receive high-speed resistance training 2 times a week for 12 consecutive weeks. Receives: Other: Cluster Set Resistance Training |
| Traditional Set Resistance Training | Active comparator | Participants in this group will receive traditional set resistance training 2 times a week for 12 consecutive weeks. Receives: Other: Traditional Set Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 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, 12 weeks
Secondary outcomes (14)
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 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). 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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
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, 12 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, 12 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, 12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 25 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
- NCT06588842
- Sponsor's protocol ID
- 20240776
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2024
- Last updated
- 3 Mar 2025
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Set Resistance Training as a Modality of Power Training in Older Adults
- ClinicalTrials.gov ID
- NCT06588842
- Acronym / sponsor ID
- 20240776
- Conditions
- Healthy Aging
- Keywords
- Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cluster Set Resistance Training | Experimental | Other: Cluster Set Resistance TrainingParticipants in this group will receive high-speed resistance training 2 times a week for 12 consecutive weeks. |
| Traditional Set Resistance Training | Active comparator | Other: Traditional Set Resistance TrainingParticipants in this group will receive traditional set resistance training 2 times a week for 12 consecutive weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Montreal Cognitive Assessment Score > 23
- No memory complaints
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Cluster Set Resistance TrainingParticipants 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. | Other | Cluster Set Resistance Training |
| Traditional Set Resistance TrainingParticipants 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. | Other | Traditional Set Resistance Training |
Primary outcome
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.
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.
14 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 12 weeks
Change in the Hopkins Verbal Learning Test
Time frame: Baseline, 12 weeks
Change in Concept Switching as measured by the Dimensional Card Sort test.
Time frame: Baseline, 12 weeks
Change in the Flanker test
Time frame: Baseline, 12 weeks
Change in Event Memory as measured by the Picture Sequence Memory Test
Time frame: Baseline, 12 weeks
Change in Information Sorting as measured by the NIH List Sorting Test
Time frame: Baseline, 12 weeks
Change in Reaction Time for a Mental Task as measured by the NIH Pattern Comparison Processing Speed Test
Time frame: Baseline, 12 weeks
Change in Mental Task as measured by Trail Making Test
Time frame: Baseline, 12 weeks
Change in the Speed of the Ten-Meter Walk Test
Time frame: Baseline, 12 weeks
Change in Time for the Five Times Sit-to-Stand Test
Time frame: Baseline, 12 weeks
Change in Distance of the Seated Medicine Ball Throw
Time frame: Baseline, 12 weeks
Change in the time required to complete the timed Up-and-Go Test.
Time frame: Baseline, 12 weeks
Change in Muscle Thickness using Ultrasound
Time frame: Baseline, 12 weeks
Change in Muscle Quality using Ultrasound
Time frame: Baseline, 12 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 3 Mar 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cluster Set Resistance Training and Traditional Set Resistance Training in people with Healthy Aging, run by University of Miami at 1 site 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 2 inclusion and 3 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 neuromuscular performance as measured by power production. (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. 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 3 Mar 2025.