Community Exercise for Fall Risk in PD

Parkinson Disease Clinical Trial

Official title:

Influence of Community-based Group Exercise on Fall Risk in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05940077
• Other study ID #: IRB-FY2019-205
• Secondary ID: 5U54GM104944-08
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2023
• Source: Idaho State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Fall
• Parkinson Disease

Intervention

Behavioral:
• Exercise
Community-based exercise involving non-contact boxing and individualized balance training

Locations

Country	Name	City	State
United States	Idaho State University	Pocatello	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Idaho State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Falls Experienced During the Study Period as Reported by Self-report	Higher scores = worse outcome	Baseline and Post-Intervention at approximately 12 weeks
Secondary	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	Baseline and Post-Intervention at approximately 12 weeks
Secondary	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)	Baseline and Post-Intervention at approximately 12 weeks
Secondary	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)	Baseline and Post-Intervention at approximately 12 weeks
Secondary	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	Baseline and Post-Intervention at approximately 12 weeks