- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164043
Efficacy of a Recreation Therapy Wellness Recovery Program for Individuals With Parkinson's Disease
March 17, 2023 updated by: Wake Forest University Health Sciences
Efficacy of a Recreation Therapy Community Based Wellness Recovery Program for Individuals With Parkinson's Disease
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of this project is to evaluate a currently active community-based Recreational Therapy (RT) Wellness Recovery Program (WRP) for individuals with Parkinson's disease (PD) to determine the efficacy of the treatment intervention.
Since PD is a progressive, degenerative neurological disease, it is critical that individuals with this diagnosis remain as active as possible to slow down the progression of the disease, improve balance and strength, and increase health-related quality of life.
The overall goal of this project is to determine the efficacy of a neuroplasticity physical activity program in terms of improving balance, improving health-related quality of life, reducing stress, and increasing satisfaction in exercise including social connectedness of group exercise.
There is evidence that the neuroplasticity model may be a more effective type of intervention than traditional exercise programs in improving symptoms of PD.
The neuroplasticity approach requires repetition of complex tasks that are high intensity and present a novel challenge.
This type of intervention has been shown to improve motor and cognitive behaviors which are critical areas of decline for those with PD.
The WRP program uses a comprehensive neuroplasticity-principled program that integrates exercise and wellness.
The PI, Julie Bradwell, LRT/CTRS is a Certified Instructor for Parkinson Wellness Recovery Power Moves.
The RT Wellness Recovery program at Wake Forest Baptist Health is modeled on the Parkinson Wellness Recovery Power Moves.
Components within the program include the Parkinson Power Moves and the exercise 4 Brain Change.
This study will be a 14-week study with the first two weeks of collecting baseline data and immediately following with a 12-week intervention program to increase balance, health-related quality of life, and satisfaction in exercise in individuals with PD as well as reduce stress.
Most research on RT interventions for this population are in traditional settings (inpatient or rehabilitation settings).
When discharged from these settings, many individuals become less active, have few social interactions and lose the benefits of exercise and physical therapy they gained while in these programs once they are home.
The WRP community-based program at Wake Forest Baptist Health has the potential to prevent secondary complications as well as slow down the progression of the disease for participants.
If the outcomes of this project suggest this type of intervention will improve the functional skills, quality of life, and/or satisfaction in exercise for individuals with PD and reduce stress, it will provide the RT discipline with evidenced based practice intervention for this population
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recreational Therapy Wellness Recovery Program Group
All 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).
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12-week community-based recreation therapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sit to Stand Test
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
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
Time Frame: Week 4 post baseline period
|
Measures functional muscle strength in the lower limbs.
This test is reported in seconds.
|
Week 4 post baseline period
|
Sit to Stand Test
Time Frame: Week 8 post baseline period
|
Measures functional muscle strength in the lower limbs.
This test is reported in seconds.
|
Week 8 post baseline period
|
Sit to Stand Test
Time Frame: Week 12 post baseline period
|
Measures functional muscle strength in the lower limbs.
This test is reported in seconds.
|
Week 12 post baseline period
|
Timed Floor Transfer Test
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
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
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Timed Floor Transfer Test
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
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
Time Frame: Week 4 post baseline period
|
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
Time Frame: Week 8 post baseline period
|
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
Time Frame: Week 12 post baseline period
|
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
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
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
Time Frame: Week 4 post baseline period
|
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
Time Frame: Week 8 post baseline period
|
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
Time Frame: Week 12 post baseline period
|
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
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
Test involves lateral moves and front and back moves with or without assistance.
measures level of assistance needed: supervision or modified assistance.
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Baseline Measure 1 performed at day 1 after signing consent
|
The Blue Foam (stand) with Trek Poles Test
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
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
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The Blue Foam (stand) with Trek Poles Test
Time Frame: Week 4 post baseline period
|
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
Time Frame: Week 8 post baseline period
|
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
Time Frame: Week 12 post baseline period
|
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)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
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
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Baseline Measure 1 performed at day 1 after signing consent
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Parkinson's Disease Questionnaire Short Form (PDQ8)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
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)
Time Frame: Week 4 post baseline period
|
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)
Time Frame: Week 8 post baseline period
|
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)
Time Frame: Week 12 post baseline period
|
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
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Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
|
Total range 1-6.
Lower scores denotes worse outcome.
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Baseline Measure 1 performed at day 1 after signing consent
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Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
Total range 1-6.
Lower scores denotes worse outcome.
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Baseline Measure 2 performed at day 2 after signing consent
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Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Week 4 post baseline period
|
Total range 1-6.
Lower scores denotes worse outcome.
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Week 4 post baseline period
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Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Week 8 post baseline period
|
Total range 1-6.
Lower scores denotes worse outcome.
|
Week 8 post baseline period
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Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Week 12 post baseline period
|
Total range 1-6.
Lower scores denotes worse outcome.
|
Week 12 post baseline period
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Perceived Stress Scale (PSS-10)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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Total range 0-4.
Lower scores denotes worse/better outcome.
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Baseline Measure 1 performed at day 1 after signing consent
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Perceived Stress Scale (PSS-10)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
|
Total range 0-4.
Lower scores denotes worse/better outcome.
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Baseline Measure 2 performed at day 2 after signing consent
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Perceived Stress Scale (PSS-10)
Time Frame: Week 4 post baseline period
|
Total range 0-4.
Lower scores denotes worse/better outcome.
|
Week 4 post baseline period
|
Perceived Stress Scale (PSS-10)
Time Frame: Week 8 post baseline period
|
Total range 0-4.
Lower scores denotes worse/better outcome.
|
Week 8 post baseline period
|
Perceived Stress Scale (PSS-10)
Time Frame: Week 12 post baseline period
|
Total range 0-4.
Lower scores denotes worse/better outcome.
|
Week 12 post baseline period
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Pain Rating Scale
Time Frame: completed week 3 after signing consent
|
10 point rating scale, low score indicates less pain.
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completed week 3 after signing consent
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Pain Rating Scale
Time Frame: completed week 4 after signing consent
|
10 point rating scale, low score indicates less pain.
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completed week 4 after signing consent
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Pain Rating Scale
Time Frame: completed week 5 after signing consent
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10 point rating scale, low score indicates less pain.
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completed week 5 after signing consent
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Pain Rating Scale
Time Frame: completed week 6 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 6 after signing consent
|
Pain Rating Scale
Time Frame: completed week 7 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 7 after signing consent
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Pain Rating Scale
Time Frame: completed week 8 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 8 after signing consent
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Pain Rating Scale
Time Frame: completed week 9 after signing consent
|
10 point rating scale, low score indicates less pain.
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completed week 9 after signing consent
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Pain Rating Scale
Time Frame: completed week 10 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 10 after signing consent
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Pain Rating Scale
Time Frame: completed week 11 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 11 after signing consent
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Pain Rating Scale
Time Frame: completed week 12 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 12 after signing consent
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Pain Rating Scale
Time Frame: completed week 13 after signing consent
|
10 point rating scale, low score indicates less pain.
|
completed week 13 after signing consent
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Pain Rating Scale
Time Frame: completed week 14 after signing consent
|
10 point rating scale, low score indicates less pain.
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completed week 14 after signing consent
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peggy Cromer, LRT, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2018
Primary Completion (Actual)
February 5, 2019
Study Completion (Actual)
February 5, 2019
Study Registration Dates
First Submitted
November 11, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (Actual)
November 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00040793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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