NCT06801704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

January 24, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 12 weeks

Secondary Outcomes (17)

  • Change in the Speed of the Ten-Meter Walk Test.

    Baseline, 12 weeks

  • Changes in Swing time of Gait.

    Baseline, 12 weeks

  • Changes in Stance Time of Gait.

    Baseline, 12 weeks

  • Changes in Double Support Time of Gait.

    Baseline, 12 weeks

  • Changes in Step Time of Gait.

    Baseline, 12 weeks

  • +12 more secondary outcomes

Study Arms (2)

Top Set Resistance Training

OTHER

Participants will be in this group receiving the top set resistance training for up to 12 weeks.

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.

Behavioral: Power Resistance Training

Interventions

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.

Top Set Resistance Training

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.

Power Resistance Training

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Joseph F. Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

January 28, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations