An interventional study of Wellness Recovery Program in Parkinson's Disease, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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).
Behavioral: Wellness Recovery Program
12-week community-based recreation therapy
Also known as: WRP
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time frame: 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.
Time frame: 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.
Time frame: Week 4 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time frame: Week 8 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Week 4 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Time frame: Week 8 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Time frame: Week 12 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Time frame: 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.
Time frame: 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.
Time frame: Week 4 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Time frame: Week 8 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Time frame: Week 12 post baseline period
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 3 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 4 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 5 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 6 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 7 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 8 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 9 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 10 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 11 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 12 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 13 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Time frame: completed week 14 after signing consent
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Plan to share: No
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Wake Forest University Health Sciences