Skip to content

Top Set and Parkinson's Disease

The Effects of Top Set Training in Combination With Power Training in Subjects With Parkinson's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06801704
Enrollment
24
Registered
2025-01-30
Start date
2025-01-28
Completion date
2025-06-30
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief 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 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.

Interventions

BEHAVIORALTop Set Resistance Training

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.

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in neuromuscular performance as measured by power production.Baseline, 12 weeksThis 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 (1RMBaseline, 12 weeksMaximal 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.

Secondary

MeasureTime frameDescription
Changes in Stance Time of Gait.Baseline, 12 weeksMovement 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.
Changes in Double Support Time of Gait.Baseline, 12 weeksMovement 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.
Changes in Step Time of Gait.Baseline, 12 weeksMovement 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.
Changes in Cadence of Gait.Baseline, 12 weeksMovement 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.
Changes in Stride Length of Gait.Baseline, 12 weeksMovement 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.
Changes in Step Length of Gait.Baseline, 12 weeksMovement 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.
Changes in Speed of Gait.Baseline, 12 weeksMovement 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.
Change in the Speed of the Ten-Meter Walk Test.Baseline, 12 weeksThe 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.
Change in Time for the Five Times Sit-to-Stand Test.Baseline, 12 weeksThe 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.
Change in Distance of the Seated Medicine Ball Throw.Baseline, 12 weeksFor 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.
Changes in the Six-Minute Walk TestBaseline, 12 weeksThe 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.
Change in the time required to complete the Timed Up-and-Go Test.Baseline, 12 weeksUpon 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.
Change in Muscle Thickness using Ultrasound.Baseline, 12 weeksThree 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.
Change in Muscle Quality using Gray Scale.Baseline, 12 weeksMuscle 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.
Changes in the Parkinson's Disease Questionnaire.Baseline, 12 weeksThe 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.
Changes in Stride Width of Gait.Baseline, 12 weeksMovement 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.
Changes in Swing time of Gait.Baseline, 12 weeksMovement 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026