Highly Challenging Balance Program to Reduce Fall Rate in PD

Parkinson's Disease Clinical Trial

Official title:

Highly Challenging Balance Program to Reduce Fall Rate in PD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972969
• Other study ID #: E3055-R
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Facility-based structured exercise
Structured exercise program in a facility with instruction and encouragement
• Home-based structured exercise
Structured exercise program in the home with instruction and encouragement
• Health education
Provision of general information about a variety of topics

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Falls Over 3 Month Period	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.	Baseline to 3 months
Secondary	Number of Falls Over 6 Month Period	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.	Baseline to 6 months