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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54GM104944-08 | U.S. NIH Grant/Contract | View source |
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Parkinson's disease (PD) affects approximately 1 million people in the United States and causes significant fall risks. This study aims to develop a community-based exercise program that reduces falls in persons with PD. By combining individualized balance activities with group boxing training, the study seeks to identify modifiable risk factors, improve balance dysfunction, and reduce falls. The findings will inform clinical practice, offering a community-based exercise model to address the urgent need for effective fall prevention interventions in PD.
Parkinson's disease (PD) is the second most common neurodegenerative disorder and effects approximately 1 million people in the United States. Falls are a significant problem for persons with PD, with incidence rates ranging from 37-80% each year. The long-term goal of this research is to develop exercise training programs to reduce falls in persons with PD.
Physical activity and exercise are commonly understood to provide significant benefits in functional mobility for persons with PD. Unfortunately, the translation of improved mobility to an actual reduction in falls has been recalcitrant to traditional exercise therapies. The following proposal is aimed at identifying the modifiable risk factors for falls in persons with PD and characterizing the effect of a novel exercise intervention on fall risk. The investigators will conduct a 12 week community-based exercise program in 20 individuals in which two validated forms of exercise training will be combined into one program. Specifically, individualized balance activities tailored to different domains of balance dysfunction for each individual will be combined with non-contact group boxing training to maximize the therapeutic benefit. The research aims of this investigation are 1) identify the individual characteristics of responders to exercise such as modifiable factors like lower-extremity kinematic joint range of motion and balance domain dysfunction at baseline, and 2) determine if a novel community-based exercise regimen that combines accepted balance and strength training protocols can synergistically improve balance dysfunction and reduce falls.
The benefits of exercise in general on PD are undisputed, but there remains an urgent, unmet need for the identification of exercise interventions that can reduce falls. The proposed research is significant because it is expected to provide evidence that a novel community-based exercise program is capable of improving functional mobility in such a way that it can reduce fall incidence for persons with PD. The research aims in this proposal are expected to directly inform clinical practice for rehabilitation providers by identifying the modifiable risk factors that lead to falls in PD and delivering a community-based exercise model that can reduce the harmful effects of falls in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community-based exercise | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Community-based exercise involving non-contact boxing and individualized balance training |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls Experienced During the Study Period as Reported by Self-report | Higher scores = worse outcome | Baseline and Post-Intervention at approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TUG | The "timed up and go test" (TUG) is a simple test of the subjects' ability to understand an instruction and perform the task of standing, walking 10ft, turning around, returning 10ft and sitting down Timed Up and Go, higher scores = worse outcome | Baseline and Post-Intervention at approximately 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idaho State University | Pocatello | Idaho | 83209 | United States |
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Participants may be excluded at this point if they demonstrate the presence of definite dementia, determined by Montreal Cognitive Assessment (MoCA < 21).
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| ID | Title | Description |
|---|---|---|
| FG000 | Community-based Exercise | Exercise: Community-based exercise involving non-contact boxing and individualized balance training |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Community-based Exercise | Exercise: Community-based exercise involving non-contact boxing and individualized balance training |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Falls Experienced During the Study Period as Reported by Self-report | Higher scores = worse outcome | Posted | Mean | Standard Error | self-reported falls | Baseline and Post-Intervention at approximately 12 weeks |
|
1 year, 5 months
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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 | Community-based Exercise | Exercise: Community-based exercise involving non-contact boxing and individualized balance training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Evan Papa | Tufts University | 617-636-4056 | evan.papa@tufts.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2020 | Aug 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2020 | Aug 9, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2021 | Aug 9, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| BBS |
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Scale = 0 - 56 (higher scores = better function) |
| Baseline and Post-Intervention at approximately 12 weeks |
| ABC | The Activities-Specific Balance Confidence (ABC) scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The ABC Scale has 16 questions that require the patient to rate his/her confidence that he/she will not lose balance or become unsteady while performing various activities. Scale: 0 - 100 (higher scores = better confidence) | Baseline and Post-Intervention at approximately 12 weeks |
| 5-STS | The Five Times Sit-to-Stand Test (5-STS) is used to asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. Scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. Higher scores = Worse outcome | Baseline and Post-Intervention at approximately 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Hoehn & Yahr | The scale has been used for the staging of the functional disability associated with Parkinson's disease. It helps in describing the progression of the disease through various stages, thus allowing the measurement of the severity of the disease. Scale range = 1-5 (higher values = worse disease severity) | Mean | Standard Deviation | units on a scale |
|
| UPDRS (motor) | The Unified Parkinson's Disease Rating Scale (UPDRS) was developed to evaluate various aspects of Parkinson's disease (PD) including non-motor and motor experiences of daily living and motor complications. We are using the motor portion in this study. It characterizes the extent and burden of the motor complications of the disease (eg., postural instability, tremor, etc.). Scale = 0 - 108 (higher values = increase severity of disease) | Mean | Standard Deviation | units on a scale |
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| Units |
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| Counts |
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| Participants |
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| Secondary | TUG | The "timed up and go test" (TUG) is a simple test of the subjects' ability to understand an instruction and perform the task of standing, walking 10ft, turning around, returning 10ft and sitting down Timed Up and Go, higher scores = worse outcome | Posted | Mean | Standard Deviation | seconds | Baseline and Post-Intervention at approximately 12 weeks |
|
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| Secondary | BBS | The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Scale = 0 - 56 (higher scores = better function) | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post-Intervention at approximately 12 weeks |
|
|
|
| Secondary | ABC | The Activities-Specific Balance Confidence (ABC) scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The ABC Scale has 16 questions that require the patient to rate his/her confidence that he/she will not lose balance or become unsteady while performing various activities. Scale: 0 - 100 (higher scores = better confidence) | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post-Intervention at approximately 12 weeks |
|
|
|
| Secondary | 5-STS | The Five Times Sit-to-Stand Test (5-STS) is used to asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. Scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. Higher scores = Worse outcome | Posted | Mean | Standard Deviation | seconds | Baseline and Post-Intervention at approximately 12 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |