Parkinson DiseaseNCT06801704
Top Set and Parkinson's Disease
A study testing Top Set Resistance Training and Power Resistance Training in people with Parkinson Disease, run by University of Miami at 1 site in United States.
Trial summary
This project will focus on improving power in adults with Parkinson's disease, since power is related to performance of daily activities and memory and decision making. The study will compare traditional power training, where the participant does all exercises as fast as possible to top set resistance training, where… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Top Set Resistance Training and Power Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 30 Jun 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's disease
- Between the ages of 30-90 years of age
- A Hoehn and Yahr score of ≤3, which will be provided by the participant's medical provider within 1 year of the study's inception.
Who cannot join
- Uncontrolled cardiovascular disease that prevents participation in a training program
- Documented HIV infection or another immunodeficiency syndrome
- Other neuromuscular diseases besides Parkinson's disease
- Current musculoskeletal injury that prevents exercise.
- Having a pacemaker
- Pregnancy
- Incarcerated individuals
- Montreal Cognitive Assessment Score below 18
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: The Effects of Top Set Training in Combination With Power Training in Subjects With Parkinson's Disease
This project will focus on improving power in adults with Parkinson's disease, since power is related to performance of daily activities and memory and decision making. The study will compare traditional power training, where the participant does all exercises as fast as possible to top set resistance training, where the participant does power training, but it is preceded by warm-up sets that progress in weight until the participant reaches 90% of the person's maximum strength. If the top set method is better than traditional power training, it could be more beneficial than existing methods in improving independence in adults with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Top Set Resistance Training, Power Resistance Training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Top Set Resistance TrainingBehavioural
Participants will receive four warm-up sets at increasingly higher resistance, followed by three sets of eight repetitions per set on six resistance-training exercises. During training participants will be allowed 1-minute rests between sets. Participants will come in person for up to 12 weeks, twice per week, for approximately 45 minutes per day.
Power Resistance TrainingBehavioural
Participants will receive a total of 24 in-person training sessions using three sets of eight repetitions per set on six power resistance-training exercises. During training participants will be allowed 1-minute rests between sets. Participants will come in person for up to 12 weeks, twice per week, for approximately 45 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Top Set Resistance Training | Other | Participants will be in this group receiving the top set resistance training for up to 12 weeks. Receives: Behavioral: Top Set Resistance Training |
| Power Resistance Training | Other | Participants will be in this group receiving the power resistance training for up to 12 weeks. Receives: Behavioral: Power 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 indicates higher power. 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 (17)
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 hundreds of a second. Two trials will be performed, and the average will be documented in meters per second. Sixty-second recoveries will be provided between trials. Total time is 420 seconds.
Measured: Baseline, 12 weeks
Changes in Swing time of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be swing time. Swing time is how long it takes to swing the back foot forward to initiate a new step. The unit of measurement is seconds.
Measured: Baseline, 12 weeks
Changes in Stance Time of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be stance time. Stance time is the duration of the time between heel strike and toe off the same foot. The unit of measurement is seconds.
Measured: Baseline, 12 weeks
Changes in Double Support Time of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be double support time. Double support time is how long both feet are in contact with the ground. The unit of measurement is seconds.
Measured: Baseline, 12 weeks
Changes in Step Time of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be step time. Step time is how long one foot is in contact with the ground. The unit of measurement is seconds.
Measured: Baseline, 12 weeks
Changes in Cadence of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be cadence. Cadence is the number of steps per minute. The unit of measurement is steps per minute.
Measured: Baseline, 12 weeks
Changes in Stride Length of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be stride length. Stride length is the distance covered when a person takes two steps. The unit of measurement is meters.
Measured: Baseline, 12 weeks
Changes in Step Length of Gait.
Movement analyses will be performed during the ten-meter walk test. The measure will be step length. Step length is the distance covered when a person takes one step. The unit of measurement is meters.
Measured: Baseline, 12 weeks
Changes in Speed of Gait.
Movement analyses will be performed during the ten-meter walk test. Gait speed is how fast a person walks. The unit of measurement is meters per second.
Measured: Baseline, 12 weeks
Changes in Stride Width of Gait.
Movement analyses will be performed during the ten-meter walk test. Stride width is the side-to-side distance between the line of the two feet during gait. The measurement is in meters.
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 arms folded across the chest and the back against the chair. On a verbal command, the participant will stand up and sit down five times as quickly as possible. Timing begins at "Go" and ends when the buttocks touch the chair after the fifth 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 the back against the chair back, while holding the 6-pound medicine ball against the 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
Changes in the Six-Minute Walk Test
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a person walks, the better cardiovascular condition. The units are meters.
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 Gray Scale.
Muscle quality will be measured through ultrasound 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
Changes in the Parkinson's Disease Questionnaire.
The Parkinson's Disease Questionnaire-39 is a 39-item self-report questionnaire that assesses Parkinson's disease-specific health-related quality over the last month across the eight quality of life dimensions and specific dimensions of functioning and well-being. Each question is scored from 0-4 points, with lower scores reflecting better quality of life.
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 posted30 Jan 2025
- Study start28 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- 24 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
- NCT06801704
- Sponsor's protocol ID
- 20241248
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2025
- Last updated
- 15 Aug 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Top Set Training in Combination With Power Training in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06801704
- Acronym / sponsor ID
- 20241248
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Jan 2025 (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 adults with Parkinson's disease, since power is related to performance of daily activities and memory and decision making. The study will compare traditional power training, where the participant does all exercises as fast as possible to top set resistance training, where the participant does power training, but it is preceded by warm-up sets that progress in weight until the participant reaches 90% of the person's maximum strength. If the top set method is better than traditional power training, it could be more beneficial than existing methods in improving independence in adults with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Top Set Resistance Training | Other | Behavioral: Top Set Resistance TrainingParticipants will be in this group receiving the top set resistance training for up to 12 weeks. |
| Power Resistance Training | Other | Behavioral: Power Resistance TrainingParticipants will be in this group receiving the power resistance training for up to 12 weeks. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Parkinson's disease
- Between the ages of 30-90 years of age
- A Hoehn and Yahr score of ≤3, which will be provided by the participant's medical provider within 1 year of the study's inception.
Key exclusion criteria (8 listed)
- Uncontrolled cardiovascular disease that prevents participation in a training program
- Documented HIV infection or another immunodeficiency syndrome
- Other neuromuscular diseases besides Parkinson's disease
- Current musculoskeletal injury that prevents exercise.
- Having a pacemaker
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 |
|---|---|---|
| Top Set Resistance TrainingParticipants will receive four warm-up sets at increasingly higher resistance, followed by three sets of eight repetitions per set on six resistance-training exercises. During training participants will be allowed 1-minute rests between sets. Participants will come in person for up to 12 weeks, twice per week, for approximately 45 minutes per day. | Behavioural | Top Set Resistance Training |
| Power Resistance TrainingParticipants will receive a total of 24 in-person training sessions using three sets of eight repetitions per set on six power resistance-training exercises. During training participants will be allowed 1-minute rests between sets. Participants will come in person for up to 12 weeks, twice per week, for approximately 45 minutes per day. | Behavioural | Power 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 indicates higher power. 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.
17 secondary outcomes
Change in the Speed of the Ten-Meter Walk Test.
Time frame: Baseline, 12 weeks
Changes in Swing time of Gait.
Time frame: Baseline, 12 weeks
Changes in Stance Time of Gait.
Time frame: Baseline, 12 weeks
Changes in Double Support Time of Gait.
Time frame: Baseline, 12 weeks
Changes in Step Time of Gait.
Time frame: Baseline, 12 weeks
Changes in Cadence of Gait.
Time frame: Baseline, 12 weeks
Changes in Stride Length of Gait.
Time frame: Baseline, 12 weeks
Changes in Step Length of Gait.
Time frame: Baseline, 12 weeks
Changes in Speed of Gait.
Time frame: Baseline, 12 weeks
Changes in Stride Width of Gait.
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
Changes in the Six-Minute Walk Test
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 Gray Scale.
Time frame: Baseline, 12 weeks
Changes in the Parkinson's Disease Questionnaire.
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 15 Aug 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 Top Set Resistance Training and Power Resistance Training in people with Parkinson Disease, 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 3 inclusion and 8 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 15 Aug 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 15 Aug 2025.