Clinical trial NCT06801704: Top Set and Parkinson's Disease
Official title: The Effects of Top Set Training in Combination With Power Training in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in neuromuscular performance as measured by power production.
timeFrame: Baseline, 12 weeks
measure: Change in neuromuscular performance as measured by 1-repetition maximum (1RM
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in the Speed of the Ten-Meter Walk Test.
timeFrame: Baseline, 12 weeks
measure: Changes in Swing time of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Stance Time of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Double Support Time of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Step Time of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Cadence of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Stride Length of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Step Length of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Speed of Gait.
timeFrame: Baseline, 12 weeks
measure: Changes in Stride Width of Gait.
timeFrame: Baseline, 12 weeks
measure: Change in Time for the Five Times Sit-to-Stand Test.
timeFrame: Baseline, 12 weeks
measure: Change in Distance of the Seated Medicine Ball Throw.
timeFrame: Baseline, 12 weeks
measure: Changes in the Six-Minute Walk Test
timeFrame: Baseline, 12 weeks
measure: Change in the time required to complete the Timed Up-and-Go Test.
timeFrame: Baseline, 12 weeks
measure: Change in Muscle Thickness using Ultrasound.
timeFrame: Baseline, 12 weeks
measure: Change in Muscle Quality using Gray Scale.
timeFrame: Baseline, 12 weeks
measure: Changes in the Parkinson's Disease Questionnaire.
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Laboratory of Neruomuscular Research and Active Aging
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F. Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References: