Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2 (MY-OT for PD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Merging Yoga and Occupational Therapy for Parkinson disease
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Individuals with a diagnosis of Parkinson's disease OR their care partners
- Individuals who read and understand English
- Individuals who can stand with or without an assistive device
- People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
- People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
- score of at least 4/6 on the short mini mental status exam
Exclusion Criteria:
- less than 18 years of age
Sites / Locations
- Colorado State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Merging Yoga and Occupational Therapy for Parkinson disease
Arm Description
The group participates in three assessment periods: August, October, and December. Then in October-December the group will receive group occupational therapy and recommended community adaptive yoga programming 2x/week for 8 weeks.
Outcomes
Primary Outcome Measures
Change in Fall Risk Factor Management
Self-report 5 scales measuring the ability to manage fall risk factors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03578653
Brief Title
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
Acronym
MY-OT for PD
Official Title
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado 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
The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Merging Yoga and Occupational Therapy for Parkinson disease
Arm Type
Experimental
Arm Description
The group participates in three assessment periods: August, October, and December. Then in October-December the group will receive group occupational therapy and recommended community adaptive yoga programming 2x/week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Merging Yoga and Occupational Therapy for Parkinson disease
Intervention Description
The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk. The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.
Primary Outcome Measure Information:
Title
Change in Fall Risk Factor Management
Description
Self-report 5 scales measuring the ability to manage fall risk factors
Time Frame
Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals with a diagnosis of Parkinson's disease OR their care partners
Individuals who read and understand English
Individuals who can stand with or without an assistive device
People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
score of at least 4/6 on the short mini mental status exam
Exclusion Criteria:
less than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Grimm, MS
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80521
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
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