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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barre exercise | Behavioral | Group barre exercise class |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Number of participants who attended at least 75% of the classes | 12 weeks |
| Retention (Study Completion) | Percent of participants who remained enrolled for the duration of the study | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
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No significant events occurred after participant enrollment. Participants were only enrolled if they met inclusion criteria.
Recruitment Period: January 2024-February 2024, Participants recruited from an academic medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | Barre Class | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Barre Class | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attendance | Number of participants who attended at least 75% of the classes | Two participants withdrew from the study during the intervention period. Attendance was calculated for the 11 participants who remained enrolled for the duration of the study. | Posted | Count of Participants | Participants | 12 weeks |
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From enrollment until end of post-testing, up to 17 weeks.
An adverse event is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical or clinical treatment or procedure that may or may not be considered related to the medical or clinical treatment or procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Barre Class | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Mild Grade 1, events unrelated to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gammon Earhart | Washington University in St. Louis | 314-286-1407 | earhartg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2025 | May 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 12 weeks |
| Gait | Mean change in gait speed pre- to post-intervention, measured in meters/second. | 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Movement Disorders Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) | MDS-UPDRS Part III: Motor Examination. A measure of Parkinson disease motor symptom severity rated on a scale from 0-132. Higher scores indicate more severe motor impairment, reflecting a worsening of symptom severity. | Mean | Standard Deviation | scores on a scale |
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| Primary | Retention (Study Completion) | Percent of participants who remained enrolled for the duration of the study | Thirteen participants enrolled in the classes. Two participants withdrew from the study during the intervention period. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | 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. | Two participants withdrew from the study during the intervention period. Following the intervention, one participant was not able to return for in-person balance assessment and one participant was excluded from preliminary motor trend data due to severe freezing of gait. Nine participants were analyzed for preliminary motor trends. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Two participants withdrew from the study during the intervention period. Following the intervention, one participant was not able to return for in-person functional strength assessment and one participant was excluded from preliminary motor trend data due to severe freezing of gait. Nine participants were analyzed for preliminary motor trends. | Posted | Mean | Standard Deviation | seconds | 12 weeks |
|
|
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| Secondary | Gait | Mean change in gait speed pre- to post-intervention, measured in meters/second. | Two participants withdrew from the study during the intervention period. Following the intervention, one participant was not able to return for in-person gait assessment and one participant was excluded from preliminary motor trend data due to severe freezing of gait. Nine participants were analyzed for preliminary motor trends. | Posted | Mean | Standard Deviation | m/s | 12 weeks |
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| Primary | 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 | All participants who completed the intervention completed the client satisfaction questionnaire. | Posted | Mean | Full Range | scores on a scale | 12 weeks |
|
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Moderate Grade 2, events unrelated to intervention |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Moderate Grade 2, reasonable possibility related to invention, reported lower back pain prior to enrolling in the study |
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| Dizziness Due to Low Blood Pressure | Cardiac disorders | Systematic Assessment | Mild Grade 1, unrelated to intervention |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Severe Grade 3, unrelated to intervention |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |