NCT07720713

Brief Summary

This investigation assesses the impact of a strengthening program on muscle metabolism in the gastrocnemius muscle (GM) and is an essential step in the establishment of future clinical intervention for the GM in people with Parkinson's disease (with healthy peers as the control group). The participants will be provided with a progressive GM strengthening program while monitoring muscle metabolism and functional changes before and after intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 27, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

June 30, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

ExerciseParkinson'sMuscle metabolismstrengthening

Outcome Measures

Primary Outcomes (1)

  • Muscle metabolic properties (P-31 MRS)

    A non-invasive measure of metabolites and their dynamics in resting and activated human muscles to explores how well muscle handles its ATP energy demands.

    Day 1 (baseline) and 4 weeks (post exercise program)

Secondary Outcomes (1)

  • Gastrocnemius strength

    Day 1 (baseline) and 4 weeks (post exercise program)

Study Arms (1)

Home exercise program

EXPERIMENTAL

Home exercise program for gastrocnemius strengthening

Other: Home Exercise Program

Interventions

All participants completed a four-week, home-based progressive strengthening program targeting GM using high-volume bodyweight exercise. Participants were instructed to perform exercises three times per week, with at least one day of rest between exercise sessions. During weeks 1 and 2, participants performed two sets of heel raises to fatigue at their prescribed level, corresponding to a subjective effort rating of 8/10. The goal was to progress toward completing 20 repetitions per set. Exercise loading was individualized based on baseline performance and adjusted throughout the intervention according to each participant's demonstrated strength progression.

Home exercise program

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, males and females, individuals with and without PD
  • Hoehn and Yahr stages 1- 4 (if diagnosed with PD)
  • Bilateral Heal Raise - minimum of 10 repetitions

You may not qualify if:

  • Unable to walk for \>5 minutes at a time with or without an assistive device
  • Any comorbidity limiting exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Motor ActivityParkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Everyone will do the same exercise program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 22, 2026

Study Start

April 27, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations