Highly Challenging Balance Program to Reduce Fall Rate in PD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-07-31

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.

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In-person exercise group

facility-based structured exercise program

Group Type EXPERIMENTAL

Facility-based structured exercise

Intervention Type BEHAVIORAL

Structured exercise program in a facility with instruction and encouragement

Remote exercise group

home-based structured exercise program

Group Type EXPERIMENTAL

Home-based structured exercise

Intervention Type BEHAVIORAL

Structured exercise program in the home with instruction and encouragement

Control group

health education

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Provision of general information about a variety of topics

Interventions

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Facility-based structured exercise

Structured exercise program in a facility with instruction and encouragement

Intervention Type BEHAVIORAL

Home-based structured exercise

Structured exercise program in the home with instruction and encouragement

Intervention Type BEHAVIORAL

Health education

Provision of general information about a variety of topics

Intervention Type BEHAVIORAL

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