Parkinson DiseasePhase 1NCT06203990
Barre Exercise in Parkinson's
A Phase 1 study testing Barre exercise in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study asks if a barre exercise program is a feasible and acceptable form of exercise for individuals with Parkinson disease. The study will also evaluate barre's potential effects on motor outcomes, including balance, strength, and functional mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Barre exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 24 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed by a neurologist with idiopathic Parkinson disease
- at least 18 years of age
- a score on the Hoehn \& Yahr (H\&Y) scale between I-III to indicate mild to moderate disease severity
- able to provide informed consent
- able to walk for 10 continuous minutes without assistance from another person
- stable medication regimen for at least one month prior to enrollment
Who cannot join
- any neurological condition other than PD
- history of orthopedic or other medical conditions that limit the ability to safely participate in the intervention or
- language, visual, or hearing barriers to participation
- evidence of dementia (Montreal Cognitive Assessment < 24) to ensure understanding of the intervention class instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Barre Exercise for People With Parkinson Disease
This study asks if a barre exercise program is a feasible and acceptable form of exercise for individuals with Parkinson disease. The study will also evaluate barre's potential effects on motor outcomes, including balance, strength, and functional mobility.
Read the detailed description
The primary objectives of this study are to: 1) evaluate the feasibility and acceptability of a barre exercise intervention and 2) gather preliminary data regarding the effect of a barre exercise intervention on balance, strength, functional mobility and quality of life in individuals with mild to moderate Parkinson disease (PD). Individuals with PD (N=15) will be recruited to participate in a pilot barre exercise class led by a certified barre instructor. The intervention will include 24, 45-50 minute group classes (twice weekly for 12 weeks, excluding holidays). Pre- and post-intervention data collection will include assessments of balance, lower extremity strength, and functional mobility.
- Conditions
- Parkinson Disease
- Being tested
- Barre exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barre exerciseBehavioural
Group barre exercise class
| Study group | Role | What they receive |
|---|---|---|
| Barre class | Experimental | Barre is an exercise modality that combines elements of classical ballet with strength training. Barre involves high repetitions of low impact, isometric movements, requires little to no equipment, and is highly modifiable for different fitness levels. Barre is traditionally performed in a class setting, which promotes increased social interaction and builds community. Furthermore, interventions with dance elements exhibit high adherence rates (often > 80%).The exercises in a barre class are also performed holding on to a fixed barre or on the floor, which may address people with PD's fear of falling. Receives: Behavioral: Barre exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Number of participants who attended at least 75% of the classes
Measured: 12 weeks
Retention (Study Completion)
Percent of participants who remained enrolled for the duration of the study
Measured: 12 weeks
Acceptability
Mean group rating on the Client Satisfaction Questionnaire, a standardized measure using Likert-scale questions to assess self-reported satisfaction of a program. Range is 1-4, higher scores indicate higher satisfaction
Measured: 12 weeks
Secondary outcomes (3)
Balance
Mean change in total score on the Mini Balance Evaluation Systems Test (Mini-BESTest) from pre- to post-intervention. The Mini-BESTest is a brief, clinically relevant assessment of balance, scored on a scale from 0 to 28, with higher scores indicating better balance. A negative change score reflects a decline in balance performance from pre- to post-intervention.
Measured: 12 weeks
Functional Strength
Mean change in time taken to complete five sit to stand movements pre- to post- intervention, measured in seconds. Longer time indicates worse performance.
Measured: 12 weeks
Gait
Mean change in gait speed pre- to post-intervention, measured in meters/second.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start29 Jan 2024
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gammon M Earhart, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203990
- Sponsor's protocol ID
- 202312097
- Status last verified
- Jun 2025
- First submitted
- 2 Jan 2024
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barre Exercise for People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT06203990
- Acronym / sponsor ID
- 202312097
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study asks if a barre exercise program is a feasible and acceptable form of exercise for individuals with Parkinson disease. The study will also evaluate barre's potential effects on motor outcomes, including balance, strength, and functional mobility.
Detailed description
The primary objectives of this study are to: 1) evaluate the feasibility and acceptability of a barre exercise intervention and 2) gather preliminary data regarding the effect of a barre exercise intervention on balance, strength, functional mobility and quality of life in individuals with mild to moderate Parkinson disease (PD). Individuals with PD (N=15) will be recruited to participate in a pilot barre exercise class led by a certified barre instructor. The intervention will include 24, 45-50 minute group classes (twice weekly for 12 weeks, excluding holidays). Pre- and post-intervention data collection will include assessments of balance, lower extremity strength, and functional mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barre class | Experimental | Behavioral: Barre exerciseBarre is an exercise modality that combines elements of classical ballet with strength training. Barre involves high repetitions of low impact, isometric movements, requires little to no equipment, and is highly modifiable for different fitness levels. Barre is traditionally performed in a class setting, which promotes increased social interaction and builds community. Furthermore, interventions with dance elements exhibit high adherence rates (often > 80%).The exercises in a barre class are also performed holding on to a fixed barre or on the floor, which may address people with PD's fear of falling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed by a neurologist with idiopathic Parkinson disease
- at least 18 years of age
- a score on the Hoehn \& Yahr (H\&Y) scale between I-III to indicate mild to moderate disease severity
- able to provide informed consent
- able to walk for 10 continuous minutes without assistance from another person
Key exclusion criteria (4 listed)
- any neurological condition other than PD
- history of orthopedic or other medical conditions that limit the ability to safely participate in the intervention or
- language, visual, or hearing barriers to participation
- evidence of dementia (Montreal Cognitive Assessment < 24) to ensure understanding of the intervention class instructions
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 |
|---|---|---|
| Barre exerciseGroup barre exercise class | Behavioural | Barre class |
Primary outcome
Attendance
Time frame: 12 weeks
Number of participants who attended at least 75% of the classes
Retention (Study Completion)
Time frame: 12 weeks
Percent of participants who remained enrolled for the duration of the study
Acceptability
Time frame: 12 weeks
Mean group rating on the Client Satisfaction Questionnaire, a standardized measure using Likert-scale questions to assess self-reported satisfaction of a program. Range is 1-4, higher scores indicate higher satisfaction
3 secondary outcomes
Balance
Time frame: 12 weeks
Functional Strength
Time frame: 12 weeks
Gait
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing Barre exercise in people with Parkinson Disease, run by Washington University School of Medicine 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 6 inclusion and 4 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 26 Jun 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Attendance (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 26 Jun 2025.