Parkinson Disease
Conditions
Brief 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.
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.
Interventions
BEHAVIORALBarre exercise
Group barre exercise class
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | 12 weeks | Number of participants who attended at least 75% of the classes |
| Retention (Study Completion) | 12 weeks | Percent of participants who remained enrolled for the duration of the study |
| Acceptability | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | 12 weeks | 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. |
| Functional Strength | 12 weeks | Mean change in time taken to complete five sit to stand movements pre- to post- intervention, measured in seconds. Longer time indicates worse performance. |
| Gait | 12 weeks | Mean change in gait speed pre- to post-intervention, measured in meters/second. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: January 2024-February 2024, Participants recruited from an academic medical center
Pre-assignment details
No significant events occurred after participant enrollment. Participants were only enrolled if they met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Barre Class |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 5 |
| Movement Disorders Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) | 26 scores on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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
Time frame: 12 weeks
Population: All participants who completed the intervention completed the client satisfaction questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barre Class | Acceptability | 3.8 scores on a scale |
Primary
Attendance
Number of participants who attended at least 75% of the classes
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Barre Class | Attendance | 10 Participants |
Primary
Retention (Study Completion)
Percent of participants who remained enrolled for the duration of the study
Time frame: 12 weeks
Population: Thirteen participants enrolled in the classes. Two participants withdrew from the study during the intervention period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Barre Class | Retention (Study Completion) | 11 Participants |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Barre Class | Balance | -0.67 scores on a scale | Standard Deviation 1.58 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Barre Class | Functional Strength | 1.45 seconds | Standard Deviation 3.1 |
Secondary
Gait
Mean change in gait speed pre- to post-intervention, measured in meters/second.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Barre Class | Gait | 0.05 m/s | Standard Deviation 0.08 |