Clinical trial NCT04164043: Efficacy of a Recreation Therapy Wellness Recovery Program for Individuals With Parkinson's Disease
Official title: Efficacy of a Recreation Therapy Community Based Wellness Recovery Program for Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Recreation Therapy
Community Based
Movement Disorder
Wellness Recovery Program
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will enter a 14 week baseline data collection period followed by a 12-week Wellness Recovery Program
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Sit to Stand Test
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Sit to Stand Test
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Sit to Stand Test
timeFrame: Week 4 post baseline period
measure: Sit to Stand Test
timeFrame: Week 8 post baseline period
measure: Sit to Stand Test
timeFrame: Week 12 post baseline period
measure: Timed Floor Transfer Test
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Timed Floor Transfer Test
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Timed Floor Transfer Test
timeFrame: Week 4 post baseline period
measure: Timed Floor Transfer Test
timeFrame: Week 8 post baseline period
measure: Timed Floor Transfer Test
timeFrame: Week 12 post baseline period
measure: Timed Up and Go (TUG) test
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Timed Up and Go (TUG) test
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Timed Up and Go (TUG) test
timeFrame: Week 4 post baseline period
measure: Timed Up and Go (TUG) test
timeFrame: Week 8 post baseline period
measure: Timed Up and Go (TUG) test
timeFrame: Week 12 post baseline period
measure: The Blue Foam (stand) with Trek Poles Test
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: The Blue Foam (stand) with Trek Poles Test
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: The Blue Foam (stand) with Trek Poles Test
timeFrame: Week 4 post baseline period
measure: The Blue Foam (stand) with Trek Poles Test
timeFrame: Week 8 post baseline period
measure: The Blue Foam (stand) with Trek Poles Test
timeFrame: Week 12 post baseline period
measure: Parkinson's Disease Questionnaire Short Form (PDQ8)
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Parkinson's Disease Questionnaire Short Form (PDQ8)
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Parkinson's Disease Questionnaire Short Form (PDQ8)
timeFrame: Week 4 post baseline period
measure: Parkinson's Disease Questionnaire Short Form (PDQ8)
timeFrame: Week 8 post baseline period
measure: Parkinson's Disease Questionnaire Short Form (PDQ8)
timeFrame: Week 12 post baseline period
measure: Psychological Need Satisfaction in Exercise Scale (PNSES)
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Psychological Need Satisfaction in Exercise Scale (PNSES)
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Psychological Need Satisfaction in Exercise Scale (PNSES)
timeFrame: Week 4 post baseline period
measure: Psychological Need Satisfaction in Exercise Scale (PNSES)
timeFrame: Week 8 post baseline period
measure: Psychological Need Satisfaction in Exercise Scale (PNSES)
timeFrame: Week 12 post baseline period
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline Measure 1 performed at day 1 after signing consent
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline Measure 2 performed at day 2 after signing consent
measure: Perceived Stress Scale (PSS-10)
timeFrame: Week 4 post baseline period
measure: Perceived Stress Scale (PSS-10)
timeFrame: Week 8 post baseline period
measure: Perceived Stress Scale (PSS-10)
timeFrame: Week 12 post baseline period
measure: Pain Rating Scale
timeFrame: completed week 3 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 4 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 5 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 6 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 7 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 8 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 9 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 10 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 11 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 12 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 13 after signing consent
measure: Pain Rating Scale
timeFrame: completed week 14 after signing consent
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peggy Cromer, LRT
role: PRINCIPAL_INVESTIGATOR
References: