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Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recreational Therapy Wellness Recovery Program Group | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellness Recovery Program | Behavioral | 12-week community-based recreation therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peggy Cromer, LRT | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2020 | Mar 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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All participants will enter a 14 week baseline data collection period followed by a 12-week Wellness Recovery Program
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| 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 |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |