Highly Challenging Balance Program to Reduce Fall Rate in PD

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    162
  • sponsor
    VA Office of Research and Development
Updated on 24 February 2021
tremor
bradykinesia
muscle rigidity
resting tremor

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.

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.

Details
Condition Parkinson's disease, Parkinson's disease, parkinson's, parkinson disease
Treatment Health education, Facility-based structured exercise, Home-based structured exercise
Clinical Study IdentifierNCT03972969
SponsorVA Office of Research and Development
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

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
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