Efficacy of a Recreation Therapy Wellness Recovery Program for Individuals With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Efficacy of a Recreation Therapy Community Based Wellness Recovery Program for Individuals With Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04164043
• Other study ID #: IRB00040793
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: February 5, 2019

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Wellness Recovery Program
12-week community-based recreation therapy

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Sit to Stand Test	Measures functional muscle strength in the lower limbs. This test is reported in seconds.	Week 4 post baseline period
Primary	Sit to Stand Test	Measures functional muscle strength in the lower limbs. This test is reported in seconds.	Week 8 post baseline period
Primary	Sit to Stand Test	Measures functional muscle strength in the lower limbs. This test is reported in seconds.	Week 12 post baseline period
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Psychological Need Satisfaction in Exercise Scale (PNSES)	Total range 1-6. Lower scores denotes worse outcome.	Week 4 post baseline period
Primary	Psychological Need Satisfaction in Exercise Scale (PNSES)	Total range 1-6. Lower scores denotes worse outcome.	Week 8 post baseline period
Primary	Psychological Need Satisfaction in Exercise Scale (PNSES)	Total range 1-6. Lower scores denotes worse outcome.	Week 12 post baseline period
Primary	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
Primary	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
Primary	Perceived Stress Scale (PSS-10)	Total range 0-4. Lower scores denotes worse/better outcome.	Week 4 post baseline period
Primary	Perceived Stress Scale (PSS-10)	Total range 0-4. Lower scores denotes worse/better outcome.	Week 8 post baseline period
Primary	Perceived Stress Scale (PSS-10)	Total range 0-4. Lower scores denotes worse/better outcome.	Week 12 post baseline period
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 3 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 4 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 5 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 6 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 7 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 8 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 9 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 10 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 11 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 12 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 13 after signing consent
Primary	Pain Rating Scale	10 point rating scale, low score indicates less pain.	completed week 14 after signing consent