Highly Challenging Balance Program to Reduce Fall Rate in PD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Highly Challenging Balance Program to Reduce Fall Rate in PD

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Facility-based structured exercise
* Behavioral: Home-based structured exercise
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of idiopathic PD At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia) Response to dopaminergic medication Exclusion Criteria: Angina pectoris History of myocardial infarction (MI) within 6 months History of ventricular dysrhythmia requiring current therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person exercise group<br>facility-based structured exercise program | Behavioral: Facility-based structured exercise<br>* Structured exercise program in a facility with instruction and encouragement<br>|
| Experimental: Remote exercise group<br>home-based structured exercise program | Behavioral: Home-based structured exercise<br>* Structured exercise program in the home with instruction and encouragement<br>|
| Active Comparator: Control group<br>health education | Behavioral: Health education<br>* Provision of general information about a variety of topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Exercise therapy, Accidental falls