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Community Exercise for Fall Risk in PD

Primary Purpose

Parkinson Disease, Fall, Exercise

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Idaho State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A diagnosis of idiopathic PD; Male or female 30 years or older at time of PD diagnosis; Hoehn & Yahr (H&Y) stages 1.0-3.0; Ability to provide informed consent in accordance with Good Clinical Practice (GCP) and local regulations. Exclusion Criteria: Idiopathic PD H&Y stage 4-5, in order to constrain motor dysfunctions to mild-to-moderate PD; Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases; Presence of definite dementia by Montreal Cognitive Assessment (MoCA <21); Central or peripheral nervous system disorders (other than PD); Myopathic disease (e.g. focal myopathy) that affects skeletal muscle structure/function; Severe cardiovascular disease that limits exercise abilities.

Sites / Locations

  • Idaho State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Community-based exercise

Arm Description

Outcomes

Primary Outcome Measures

Number of Falls Experienced During the Study Period as Reported by Self-report
Higher scores = worse outcome

Secondary Outcome Measures

TUG
The "timed up and go test" (TUG) is a simple test of the subjects' ability to understand an instruction and perform the task of standing, walking 10ft, turning around, returning 10ft and sitting down Timed Up and Go, higher scores = worse outcome
BBS
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Scale = 0 - 56 (higher scores = better function)
ABC
The Activities-Specific Balance Confidence (ABC) scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The ABC Scale has 16 questions that require the patient to rate his/her confidence that he/she will not lose balance or become unsteady while performing various activities. Scale: 0 - 100 (higher scores = better confidence)
5-STS
The Five Times Sit-to-Stand Test (5-STS) is used to asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. Scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. Higher scores = Worse outcome

Full Information

First Posted
June 27, 2023
Last Updated
August 11, 2023
Sponsor
Idaho State University
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1. Study Identification

Unique Protocol Identification Number
NCT05940077
Brief Title
Community Exercise for Fall Risk in PD
Official Title
Influence of Community-based Group Exercise on Fall Risk in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Idaho State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Parkinson's disease (PD) affects approximately 1 million people in the United States and causes significant fall risks. This study aims to develop a community-based exercise program that reduces falls in persons with PD. By combining individualized balance activities with group boxing training, the study seeks to identify modifiable risk factors, improve balance dysfunction, and reduce falls. The findings will inform clinical practice, offering a community-based exercise model to address the urgent need for effective fall prevention interventions in PD.
Detailed Description
Parkinson's disease (PD) is the second most common neurodegenerative disorder and effects approximately 1 million people in the United States. Falls are a significant problem for persons with PD, with incidence rates ranging from 37-80% each year. The long-term goal of this research is to develop exercise training programs to reduce falls in persons with PD. Physical activity and exercise are commonly understood to provide significant benefits in functional mobility for persons with PD. Unfortunately, the translation of improved mobility to an actual reduction in falls has been recalcitrant to traditional exercise therapies. The following proposal is aimed at identifying the modifiable risk factors for falls in persons with PD and characterizing the effect of a novel exercise intervention on fall risk. The investigators will conduct a 12 week community-based exercise program in 20 individuals in which two validated forms of exercise training will be combined into one program. Specifically, individualized balance activities tailored to different domains of balance dysfunction for each individual will be combined with non-contact group boxing training to maximize the therapeutic benefit. The research aims of this investigation are 1) identify the individual characteristics of responders to exercise such as modifiable factors like lower-extremity kinematic joint range of motion and balance domain dysfunction at baseline, and 2) determine if a novel community-based exercise regimen that combines accepted balance and strength training protocols can synergistically improve balance dysfunction and reduce falls. The benefits of exercise in general on PD are undisputed, but there remains an urgent, unmet need for the identification of exercise interventions that can reduce falls. The proposed research is significant because it is expected to provide evidence that a novel community-based exercise program is capable of improving functional mobility in such a way that it can reduce fall incidence for persons with PD. The research aims in this proposal are expected to directly inform clinical practice for rehabilitation providers by identifying the modifiable risk factors that lead to falls in PD and delivering a community-based exercise model that can reduce the harmful effects of falls in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Fall, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community-based exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Community-based exercise involving non-contact boxing and individualized balance training
Primary Outcome Measure Information:
Title
Number of Falls Experienced During the Study Period as Reported by Self-report
Description
Higher scores = worse outcome
Time Frame
Baseline and Post-Intervention at approximately 12 weeks
Secondary Outcome Measure Information:
Title
TUG
Description
The "timed up and go test" (TUG) is a simple test of the subjects' ability to understand an instruction and perform the task of standing, walking 10ft, turning around, returning 10ft and sitting down Timed Up and Go, higher scores = worse outcome
Time Frame
Baseline and Post-Intervention at approximately 12 weeks
Title
BBS
Description
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Scale = 0 - 56 (higher scores = better function)
Time Frame
Baseline and Post-Intervention at approximately 12 weeks
Title
ABC
Description
The Activities-Specific Balance Confidence (ABC) scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The ABC Scale has 16 questions that require the patient to rate his/her confidence that he/she will not lose balance or become unsteady while performing various activities. Scale: 0 - 100 (higher scores = better confidence)
Time Frame
Baseline and Post-Intervention at approximately 12 weeks
Title
5-STS
Description
The Five Times Sit-to-Stand Test (5-STS) is used to asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. Scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. Higher scores = Worse outcome
Time Frame
Baseline and Post-Intervention at approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of idiopathic PD; Male or female 30 years or older at time of PD diagnosis; Hoehn & Yahr (H&Y) stages 1.0-3.0; Ability to provide informed consent in accordance with Good Clinical Practice (GCP) and local regulations. Exclusion Criteria: Idiopathic PD H&Y stage 4-5, in order to constrain motor dysfunctions to mild-to-moderate PD; Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases; Presence of definite dementia by Montreal Cognitive Assessment (MoCA <21); Central or peripheral nervous system disorders (other than PD); Myopathic disease (e.g. focal myopathy) that affects skeletal muscle structure/function; Severe cardiovascular disease that limits exercise abilities.
Facility Information:
Facility Name
Idaho State University
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Community Exercise for Fall Risk in PD

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