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This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.
Background/Rationale. Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD include resting tremor, rigidity, bradykinesia, and postural instability/gait disturbance. In addition, people with PD fall frequently, with 60% falling annually and two-thirds of these falling recurrently. Identifying interventions that successfully improve postural control and reduce fall rate is critical to reduce disability, improve quality of life, and potentially increase survival in patients with PD. Recent randomized, controlled trials (RCT) have examined the effects of exercise and physical therapy interventions on reducing falls in patients with PD; however, with mixed results.
Objectives. There is a limited availability of effective treatment options to reduce falls in PD. In this context, some studies suggest that highly challenging exercise approaches may lead to better outcomes. The investigators propose investigating the effects of two theoretically driven, progressive, highly challenging exercise programs: 1) a structured exercise program at the VA and 2) a structured exercise program at home. There will also be a control group in which health education is provided.
Methods. The investigators propose to conduct an RCT evaluating effects on fall rate. A total of 162 VA patients with mild-to-moderate PD will be randomly assigned to one of the three 3-month interventions: in-person exercise at the VA, remotely-delivered exercise, or health education. Outcomes will be compared between each intervention group and the control group. Fall rates will be compared between groups with the use of negative binomial regression models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person exercise group | Experimental | facility-based structured exercise program |
|
| Remote exercise group | Experimental | home-based structured exercise program |
|
| Control group | Active Comparator | health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facility-based structured exercise | Behavioral | Structured exercise program in a facility with instruction and encouragement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls Over 3 Month Period | Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls Over 6 Month Period | Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 |
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| ID | Title | Description |
|---|---|---|
| FG000 | In-person Exercise Group | facility-based structured exercise program Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement |
| FG001 | Remote Exercise Group | home-based structured exercise program Home-based structured exercise: Structured exercise program in the home with instruction and encouragement |
| FG002 | Control Group | health education Health education: Provision of general information about a variety of topics |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-month Follow-up |
|
| ||||||||||||||||||
| 6-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In-person Exercise Group | facility-based structured exercise program Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement |
| BG001 | Remote Exercise Group |
| 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 | Number of Falls Over 3 Month Period | Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | Posted | Mean | Standard Deviation | number of falls | Baseline to 3 months |
|
Adverse events collected over the 6-month participation period
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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 | In-person Exercise Group | facility-based structured exercise program Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6407 | david.sparrow@va.gov |
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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 | Mar 16, 2022 | Feb 27, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Jun 6, 2023 | ICF_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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| Home-based structured exercise | Behavioral | Structured exercise program in the home with instruction and encouragement |
|
| Health education | Behavioral | Provision of general information about a variety of topics |
|
| Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| NOT COMPLETED |
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|
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
| BG002 | Control Group | health education Health education: Provision of general information about a variety of topics |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | Control Group | health education Health education: Provision of general information about a variety of topics |
|
|
|
| Secondary | Number of Falls Over 6 Month Period | Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | Posted | Mean | Standard Deviation | number of falls | Baseline to 6 months |
|
|
|
|
| 2 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Remote Exercise Group | home-based structured exercise program Home-based structured exercise: Structured exercise program in the home with instruction and encouragement | 2 | 58 | 0 | 58 | 0 | 58 |
| EG002 | Control Group | health education Health education: Provision of general information about a variety of topics | 1 | 53 | 0 | 53 | 0 | 53 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Incidence Rate Ratio |
| 0.26 |
| 2-Sided |
| 95 |
| 0.11 |
| 0.58 |
| Superiority |
| negative binomial regression | <0.05 | Incidence Rate Ratio | 0.58 | 2-Sided | 95 | 0.25 | 1.38 | Superiority |