Community Exercise for Fall Risk in PD

NCT05940077 | Completed Results

• 2 other identifiers: IRB-FY2019-2055U54GM104944-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Fall; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• TUG

  Baseline and Post-Intervention at approximately 12 weeks

• BBS

  Baseline and Post-Intervention at approximately 12 weeks

• ABC

  Baseline and Post-Intervention at approximately 12 weeks

• 5-STS

  Baseline and Post-Intervention at approximately 12 weeks

Study Arms (1)

Community-based exercise

EXPERIMENTAL

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Community-based exercise

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idaho State University: lead

Study Sites (1)

Idaho State University

Pocatello, Idaho, 83209, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Evan Papa
• Organization: Tufts University

evan.papa@tufts.edu

617-636-4056

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 11, 2023
• Study Start: July 15, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)