ParkinsonNCT07720713
Impact of Exercise on Muscle Metabolism and Function for Persons With Parkinsons
A study testing Home Exercise Program in people with Parkinson, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 30 Jun 2023
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-80 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
Who cannot join
- Unable to walk for >5 minutes at a time with or without an assistive device
- Any comorbidity limiting exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Muscle Metabolism Using Magnetic Resonance Spectroscopy With Clinical Strengthening in Parkinson's Disease
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.
Read the detailed description
This is a repeated measures study with a total of 20 participants (15 individuals with varying PD severity and 5 age matched controls). Strength, functional ability, and metabolic properties (MRS) of the GM will be measured on participants before and after a 4 week progressive strengthening program for the GM. The program is designed to utilize high volume exercise to account for unique properties of the GM (2 sets of heel raises to fatigue, 3 times a week). Loading will be individualized and progressed based on participant strength. There will be contact for accountability/direction on exercise progression. Demographic data including sex, age, medications, and years since disease onset will be collected.
- Conditions
- Parkinson
- Being tested
- Home Exercise Program
- Keywords
- Exercise, Parkinson's, Muscle metabolism, strengthening
- Medical subject headings
- Motor Activity, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise program | Experimental | Home exercise program for gastrocnemius strengthening Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (baseline) and 4 weeks (post exercise program)
Secondary outcomes (1)
Gastrocnemius strength
Clinical measure of gastrocnemius strength, tested unilaterally, using the Calf -Raise Senior Test with a stadiometer for objective heel raise strength.
Measured: Day 1 (baseline) and 4 weeks (post exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start27 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Everyone will do the same exercise program
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staci Shearin, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720713
- Sponsor's protocol ID
- STU-2021-0322
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscle Metabolism Using Magnetic Resonance Spectroscopy With Clinical Strengthening in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07720713
- Acronym / sponsor ID
- STU-2021-0322
- Conditions
- Parkinson
- Keywords
- Exercise, Parkinson's, Muscle metabolism, strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Jul 2026 (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 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.
Detailed description
This is a repeated measures study with a total of 20 participants (15 individuals with varying PD severity and 5 age matched controls). Strength, functional ability, and metabolic properties (MRS) of the GM will be measured on participants before and after a 4 week progressive strengthening program for the GM. The program is designed to utilize high volume exercise to account for unique properties of the GM (2 sets of heel raises to fatigue, 3 times a week). Loading will be individualized and progressed based on participant strength. There will be contact for accountability/direction on exercise progression. Demographic data including sex, age, medications, and years since disease onset will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Everyone will do the same exercise program
| Arm | Type | Receives |
|---|---|---|
| Home exercise program | Experimental | Other: Home Exercise ProgramHome exercise program for gastrocnemius strengthening |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-80 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
Key exclusion criteria (2 listed)
- Unable to walk for >5 minutes at a time with or without an assistive device
- Any comorbidity limiting exercise
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 |
|---|---|---|
| Home Exercise ProgramAll 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. | Other | Home exercise program |
Primary outcome
Muscle metabolic properties (P-31 MRS)
Time frame: Day 1 (baseline) and 4 weeks (post exercise program)
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.
1 secondary outcome
Gastrocnemius strength
Time frame: Day 1 (baseline) and 4 weeks (post exercise program)
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 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program in people with Parkinson, run by University of Texas Southwestern Medical Center 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 2 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 22 Jul 2026. 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?
Muscle metabolic properties (P-31 MRS) (time frame: Day 1 (baseline) and 4 weeks (post exercise program)). 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 22 Jul 2026.