NCT03972969

Highly Challenging Balance Program to Reduce Fall Rate in PD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
BEHAVIORAL	Facility-based structured exercise	Structured exercise program in a facility with instruction and encouragement
BEHAVIORAL	Home-based structured exercise	Structured exercise program in the home with instruction and encouragement
BEHAVIORAL	Health education	Provision of general information about a variety of topics

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-02-28
• Completion: 2023-07-31
• First posted: 2019-06-04
• Last updated: 2024-06-21
• Results posted: 2024-06-21

Locations

1 site across 1 country: United States