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Clinical Trials/NCT03972969
NCT03972969
Completed
Not Applicable

Highly Challenging Balance Program to Reduce Fall Rate in PD

VA Office of Research and Development1 site in 1 country162 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
VA Office of Research and Development
Enrollment
162
Locations
1
Primary Endpoint
Number of Falls Over 3 Month Period
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
July 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Falls Over 3 Month Period

Time Frame: 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 Outcomes

  • Number of Falls Over 6 Month Period(Baseline to 6 months)

Study Sites (1)

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