Study Stopped
Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff
Efficacy of a Recreation Therapy Wellness Recovery Program for Individuals With Parkinson's Disease
1 other identifier
interventional
3
1 country
1
Brief Summary
The Recreation Therapy Wellness Recovery Program conducts group classes which provide repetitive training of foundational skills designed specifically for those with Parkinson's Disease. The course will encourage bigger and faster movements (adapted from the Parkinson Wellness Recovery, PWR!Moves ® program) and education on optimal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2019
CompletedFirst Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedMarch 22, 2023
September 1, 2021
11 months
November 11, 2019
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (47)
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Baseline Measure 1 performed at day 1 after signing consent
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Baseline Measure 2 performed at day 2 after signing consent
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 4 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 8 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 12 post baseline period
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Baseline Measure 1 performed at day 1 after signing consent
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Baseline Measure 2 performed at day 2 after signing consent
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Week 4 post baseline period
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Week 8 post baseline period
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Week 12 post baseline period
Timed Up and Go (TUG) test
Test involves a series of transitional movements including sit to stand, walking, turning and sit to stand. The test is reported in seconds.
Baseline Measure 1 performed at day 1 after signing consent
Timed Up and Go (TUG) test
Test involves a series of transitional movements including sit to stand, walking, turning and sit to stand. The test is reported in seconds.
Baseline Measure 2 performed at day 2 after signing consent
Timed Up and Go (TUG) test
Test involves a series of transitional movements including sit to stand, walking, turning and sit to stand. The test is reported in seconds.
Week 4 post baseline period
Timed Up and Go (TUG) test
Test involves a series of transitional movements including sit to stand, walking, turning and sit to stand. The test is reported in seconds.
Week 8 post baseline period
Timed Up and Go (TUG) test
Test involves a series of transitional movements including sit to stand, walking, turning and sit to stand. The test is reported in seconds.
Week 12 post baseline period
The Blue Foam (stand) with Trek Poles Test
Test involves lateral moves and front and back moves with or without assistance. measures level of assistance needed: supervision or modified assistance.
Baseline Measure 1 performed at day 1 after signing consent
The Blue Foam (stand) with Trek Poles Test
Test involves lateral moves and front and back moves with or without assistance. measures level of assistance needed: supervision or modified assistance.
Baseline Measure 2 performed at day 2 after signing consent
The Blue Foam (stand) with Trek Poles Test
Test involves lateral moves and front and back moves with or without assistance. measures level of assistance needed: supervision or modified assistance.
Week 4 post baseline period
The Blue Foam (stand) with Trek Poles Test
Test involves lateral moves and front and back moves with or without assistance. measures level of assistance needed: supervision or modified assistance.
Week 8 post baseline period
The Blue Foam (stand) with Trek Poles Test
Test involves lateral moves and front and back moves with or without assistance. measures level of assistance needed: supervision or modified assistance.
Week 12 post baseline period
Parkinson's Disease Questionnaire Short Form (PDQ8)
This is a spcific health related quality of life instrument created for individuals with Parkinson's Disease. Likert scale (0 - 4), higher the score the greater the functioning. Overall score ranges from 0 -32. Higher scores indicate greater impact of the disease
Baseline Measure 1 performed at day 1 after signing consent
Parkinson's Disease Questionnaire Short Form (PDQ8)
This is a spcific health related quality of life instrument created for individuals with Parkinson's Disease. Likert scale (0 - 4), higher the score the greater the functioning. Overall score ranges from 0 -32. Higher scores indicate greater impact of the disease
Baseline Measure 2 performed at day 2 after signing consent
Parkinson's Disease Questionnaire Short Form (PDQ8)
This is a spcific health related quality of life instrument created for individuals with Parkinson's Disease. Likert scale (0 - 4), higher the score the greater the functioning. Overall score ranges from 0 -32. Higher scores indicate greater impact of the disease
Week 4 post baseline period
Parkinson's Disease Questionnaire Short Form (PDQ8)
This is a spcific health related quality of life instrument created for individuals with Parkinson's Disease. Likert scale (0 - 4), higher the score the greater the functioning. Overall score ranges from 0 -32. Higher scores indicate greater impact of the disease
Week 8 post baseline period
Parkinson's Disease Questionnaire Short Form (PDQ8)
This is a spcific health related quality of life instrument created for individuals with Parkinson's Disease. Likert scale (0 - 4), higher the score the greater the functioning. Overall score ranges from 0 -32. Higher scores indicate greater impact of the disease
Week 12 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Baseline Measure 1 performed at day 1 after signing consent
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Baseline Measure 2 performed at day 2 after signing consent
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Week 4 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Week 8 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Week 12 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Baseline Measure 1 performed at day 1 after signing consent
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Baseline Measure 2 performed at day 2 after signing consent
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Week 4 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Week 8 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Week 12 post baseline period
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 3 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 4 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 5 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 6 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 7 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 8 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 9 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 10 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 11 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 12 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 13 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
completed week 14 after signing consent
Study Arms (1)
Recreational Therapy Wellness Recovery Program Group
EXPERIMENTALAll participants will enter a baseline data collection period for two weeks. They will then participate in a 12-week community-based Recreational Therapy (RT) Wellness Recovery Program (WRP) for individuals with Parkinson's disease (WRP).
Interventions
12-week community-based recreation therapy
Eligibility Criteria
You may qualify if:
- Potential subjects in this study will have a diagnosis of Parkinson's disease.
- Potential subjects in this study are able to tolerate a 60-minute exercise program; participants complete the Parkinson Power Moves Class Application which requires a release form and a physician's signature that identifies any limitations or precautions to be taken in the program.
You may not qualify if:
- Individuals who do not have a diagnosis of Parkinson's disease or those with PD who are not medically cleared to participate in the program will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peggy Cromer, LRT
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 15, 2019
Study Start
March 6, 2018
Primary Completion
February 5, 2019
Study Completion
February 5, 2019
Last Updated
March 22, 2023
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share