Highly Challenging Balance Program to Reduce Fall Rate in PD

Not Applicable

Completed

Conditions: Parkinson's Disease

Interventions: Behavioral: Facility-based structured exercise
Behavioral: Health education
Behavioral: Home-based structured exercise

Registration Number: NCT03972969

Lead Sponsor: VA Office of Research and Development

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 162

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person exercise group	Facility-based structured exercise	facility-based structured exercise program
Control group	Health education	health education
Remote exercise group	Home-based structured exercise	home-based structured exercise program

Primary Outcome Measures

Name	Time	Method
Number of Falls Over 3 Month Period	Baseline to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Falls Over 6 Month Period	Baseline to 6 months	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.