Community Exercise for Fall Risk in PD

Sponsor
Idaho State University (Other)
Overall Status
Completed
CT.gov ID
NCT05940077
Collaborator
(none)
19
1
1
20.5
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Community-based Group Exercise on Fall Risk in Parkinson's Disease
Actual Study Start Date :
Jul 15, 2020
Actual Primary Completion Date :
Mar 30, 2022
Actual Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Community-based exercise

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

Outcome Measures

Primary Outcome Measures

  1. Number of falls experienced during the study period as reported by self-report [12 months]

    Higher scores = worse outcome

Secondary Outcome Measures

  1. TUG [12 months]

    Timed Up and Go, higher scores = worse outcome

  2. BBS [12 months]

    Berg Balance Scale, higher scores = better outcome

  3. ABC [12 months, higher scores = better outcome]

    Activities-Specific Balance Confidence scale

  4. 5-STS [12 months]

    Five Times Sit-to-Stand, higher scores = worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • A diagnosis of idiopathic PD; Male or female ages 50-65, 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Idaho State University Pocatello Idaho United States 83209

Sponsors and Collaborators

  • Idaho State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evan Papa, Associate Professor, Idaho State University
ClinicalTrials.gov Identifier:
NCT05940077
Other Study ID Numbers:
  • IRB-FY2019-205
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023