- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513521
Speed-specific Training and Ultrasound
Velocity- Versus Load-based Training on Muscle Quality and Performance in Older Persons
Study Overview
Status
Intervention / Treatment
Detailed Description
Resistance training has been shown to have a significant impact on strength, power, cognition, functionality, activities of daily living, and quality of life throughout the aging process(Hunter et al., 2004; Peterson et al., 2010; Wen et al., 2011). Specifically, power training is especially beneficial to older adults to combat the age-related slowing of movement that occurs. and changes in age-related cognitive decline. However, in evaluating these measures and prescribing a power training program, the deficit on either the load or velocity end of the power spectrum unique to these individuals is often overlooked. Therefore, the evaluation of these components coupled with a custom training program to fit their needs on either the load end or velocity end of the spectrum may provide significant benefit to the functionality of older adults. Additionally, sleep quality has been shown to have a significant impact on cognitive performance(Alhola & Polo-Kantola, 2007) and may impact the changes in cognition that The investigators observe with a resistance training program.
Further, muscle mass has been shown to decrease with aging as a result of a variety of physiological changes that occur in the body, including the reduction in motor units and muscle fibers and these changes have a significant impact on the mobility of older adults(Charlier et al., 2016; Evans & Campbell, 1993). Resistance training has been shown to have an impact on the progression and development of sarcopenia and has been supported in the research with both the use of power and strength training programs(Balachandran et al., 2014; Roth et al., 2000). Ultrasonography evaluation of muscle quality can provide valuable information on the changes to the musculature that occur with training programs in older adults(Pardo et al., 2018).
While the impact of power and strength training on muscle quality has been shown(Ivey et al., 2000; Nogueira et al., 2009), the impact of a unique load velocity design to target power deficits on muscle quality is prohibitive. Therefore, this research is designed to evaluate the impact of load training and velocity training on muscle quality in healthy, older adults as well as changes in functionality, cognition, and sleep.
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Montreal Cognitive Assessment (MOCA) > 23 and no memory loss complaints.
Exclusion Criteria:
- Any uncontrolled cardiovascular or neuromuscular diseases that prevent 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 quadricep muscles
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: High-velocity interval training
Subjects will be provided high-speed, low-load training to target improvements in velocity.
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For the velocity training protocol, the 11 exercises will be completed at 40% of their 1RM.
In the first three weeks of training, the loading volume will be increased gradually.
During week one participants will complete one set of each exercise.
Week two will consist of two sets, and weeks 3-12, three sets.
Keiser pneumatic resistance machines are interfaced with a laboratory computer, which allows the transfer and analysis of data including force, velocity, and power.
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Experimental: Resistance training
Subjects will be provided low-speed, high-load training to target improvements in velocity
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For the load training protocol, the 11 exercises will be completed at 79% of their 1RM.
In the first three weeks of training, the loading volume will be increased gradually.
During week one participants will complete one set of each exercise.
Week two will consist of two sets, and weeks 3-12, three sets.
Keiser pneumatic resistance machines are interfaced with a laboratory computer, which allows the transfer and analysis of data including force, velocity, and power.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Five-time sit-to-stand
Time Frame: 5 minutes
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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 touches the chair after the 5th repetition.
One practice and two testing trials will be performed.
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5 minutes
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10-meter walk
Time Frame: 5 minutes
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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 m·s-1.
One-minute recoveries will be provided between trials.
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5 minutes
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One-repetition maximum (1RM) testing
Time Frame: 10 minutes
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One-repetition maximum (1RM) strength testing will include leg press and chest press.
After a warm-up, the subject do 10 repetitions a low resistance.
The test will begin using a weight near the predicted maximum.
The weight will then be increased or decreased depending on the subject's ability to perform the repetition using correct technique.
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10 minutes
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Home Sleep Testing
Time Frame: 8 hours
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Study participants will have a home sleep study using the NoxA1 system that allows for monitoring of sleep (i.e., EEG) along with respiratory effort and oxygen saturation.
The goal of the home sleep study is to exclude other respiratory-related sleep disorders, such as central sleep apnea and Cheyne-Stokes breathing, and efficiently characterize OSA severity.
These sleep assessments are routinely done in clinical practice and will be conducted by the participant at home using self-applied portable monitors that are powered by one AA battery.
This will only be worn for one night and instruction on setup will be given at the laboratory with a take-home packet for setup.
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8 hours
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Actigraphy
Time Frame: 168 hours
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An actigraph, which measures activity levels, will be worn on the wrist for seven consecutive 24-hour periods, to collect data on habitual sleep duration.
Wrist actigraphy is a technique for measuring movement over an extended recording period (days to weeks).
Data garnered from wrist actigraphy will be used to derive variables such as habitual total sleep time, number and duration of awakenings per night, and napping behavior.
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168 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dimensional Card Sort (DCCS)
Time Frame: 5 minutes
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This is an iPad-administered task (by a research assistant) that measures the flexible use of rules to govern behavior as a means of providing an index of executive function development.
The DCCS 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.
For example, after four straight trials the subject is correct on matching shapes, the participant may be asked to match on color on the next trial and then go back to shape, thus requiring the cognitive flexibility to quickly choose the correct stimulus.
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5 minutes
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Flanker test
Time Frame: 5 minutes
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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 (in our case 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).
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5 minutes
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Picture Sequence Memory Test (PSMT)
Time Frame: 5 minutes
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The PSMT can test episodic memory in persons from 3 through 85.
The PSMT involves presentation of sequences of pictured objects and activities in a fixed order on a computer screen and simultaneously verbally described, that the participant must remember and then reproduce over three learning trials.
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5 minutes
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List Sorting Test
Time Frame: 5 minutes
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The List Sorting Working Memory Test assesses working memory and is part of the NIH Toolbox Cognition Battery.
List Sorting is a sequencing task requiring subjects to sort and sequence stimuli that are presented visually and auditorily.
Lists may include animal to be sorted by size, foods to be sorted by size, or a combination of the two to be sorted by size.
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5 minutes
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Pattern Comparison Test
Time Frame: 5 minutes
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The Toolbox Pattern Comparison Processing Speed Test is the assessment of choice to measure reaction time in older adults and is also used to measure processing speed.
During the test, participants are asked to identify whether two visual patterns are the "same" or "not the same."
Scores reflect the number of correct responses within a finite time frame.
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5 minutes
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Power Testing
Time Frame: 15 minutes
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Power testing will begin with a warm-up of 10 repetitions at 30% 1RM, followed by a 1-minute recovery period.
A second warm-up of 5 repetitions at 30% 1RM will then be performed as rapidly as possible.
Peak muscle power will then be assessed at 8 relative intensities (40, 50, 60, 70, and 80% 1RM) on the same resistance machines used for strength testing.
The percentages will be randomized to reduce any order effect.
For each repetition, the concentric phase will be performed as fast as possible, and the eccentric phase will be performed over 2-3 seconds.
Each repetition will be verbally cued "3.2.1.
Go!"
This testing protocol is commonly used for power testing.
Any repetition not performed properly will be repeated after a 1-minute break.
Power output will be recorded from the display of each machine and cross-referenced with the electronic spreadsheets.
Power testing for leg press and chest press, which are to be used as variables in our analysis, will occur before the beginning
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15 minutes
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Ultrasound measurement
Time Frame: 15 minutes
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Ultrasound images of the quadriceps femoris muscle (vastus medialis, vastus lateralis, vastus intermedius, rectus femoris) will be taken on the thigh at the two-thirds and midpoint of the length between the anterior superior iliac spine and the upper border of the patella.
A LOGIQ P9 R3 Ultrasound System (GE Healthcare, Buckinghamshire, UK) and 3-12 MHz linear array transducer probe will be used, and testing will be conducted on a padded treatment table.
Care will be taken to maintain the same standardized body positions and probe locations for all participants.
Minimal pressure will be applied by the researcher to reduce any tissue compression that would artificially influence the results.
Before acquiring measurements, subjects will rest on the examination table for five minutes to avoid any potential movement-induced stiffness.
To improve acoustic contact between the probe and skin, a water-soluble transmission gel will be used on the head of the probe.
Both legs will be imaged.
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15 minutes
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Isokinetic Testing
Time Frame: 30 minutes
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The Biodex 4 Dynamometer will be used for all isokinetic testing.
Subjects will be asked to perform an isokinetic warmup of 10 repetitions of leg extension at 270 deg/s, be given a three-minute recovery, and then perform three maximal isokinetic quadriceps extensions at 90, 180, and 300 degrees/second using 2-minute recoveries in between sets.
All results will be recorded.
The repetitions producing the highest peak torque among the three efforts, and the average power for the repetitions will be used for statistical evaluation.
Given the nature of isokinetic testing the resistance is at the speeds we have chosen, far below maximum.
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30 minutes
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Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 20220489
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
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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