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Highly Challenging Balance Program to Reduce Fall Rate in PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facility-based structured exercise
Home-based structured exercise
Health education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, Exercise therapy, Accidental falls

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

In-person exercise group

Remote exercise group

Control group

Arm Description

facility-based structured exercise program

home-based structured exercise program

health education

Outcomes

Primary Outcome Measures

Falls
Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

Secondary Outcome Measures

Falls
Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

Full Information

First Posted
May 31, 2019
Last Updated
August 30, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03972969
Brief Title
Highly Challenging Balance Program to Reduce Fall Rate in PD
Official Title
Highly Challenging Balance Program to Reduce Fall Rate in PD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Exercise therapy, Accidental falls

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person exercise group
Arm Type
Experimental
Arm Description
facility-based structured exercise program
Arm Title
Remote exercise group
Arm Type
Experimental
Arm Description
home-based structured exercise program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
health education
Intervention Type
Behavioral
Intervention Name(s)
Facility-based structured exercise
Intervention Description
Structured exercise program in a facility with instruction and encouragement
Intervention Type
Behavioral
Intervention Name(s)
Home-based structured exercise
Intervention Description
Structured exercise program in the home with instruction and encouragement
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Provision of general information about a variety of topics
Primary Outcome Measure Information:
Title
Falls
Description
Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Falls
Description
Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Highly Challenging Balance Program to Reduce Fall Rate in PD

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