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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Recovery Program
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Recreation Therapy, Community Based, Movement Disorder, Wellness Recovery Program

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recreational Therapy Wellness Recovery Program Group

Arm Description

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).

Outcomes

Primary Outcome Measures

Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Timed Floor Transfer Test
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Pain Rating Scale
10 point rating scale, low score indicates less pain.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2019
Last Updated
March 17, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04164043
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Recreation Therapy, Community Based, Movement Disorder, Wellness Recovery Program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will enter a 14 week baseline data collection period followed by a 12-week Wellness Recovery Program
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recreational Therapy Wellness Recovery Program Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Wellness Recovery Program
Other Intervention Name(s)
WRP
Intervention Description
12-week community-based recreation therapy
Primary Outcome Measure Information:
Title
Sit to Stand Test
Description
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
Title
Sit to Stand Test
Description
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
Title
Sit to Stand Test
Description
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time Frame
Week 4 post baseline period
Title
Sit to Stand Test
Description
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time Frame
Week 8 post baseline period
Title
Sit to Stand Test
Description
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Time Frame
Week 12 post baseline period
Title
Timed Floor Transfer Test
Description
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
Title
Timed Floor Transfer Test
Description
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
Title
Timed Floor Transfer Test
Description
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Time Frame
Week 4 post baseline period
Title
Timed Floor Transfer Test
Description
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Time Frame
Week 8 post baseline period
Title
Timed Floor Transfer Test
Description
Measures vestibular balance and functional mobility to determine risk of falling. This test is reported in seconds.
Time Frame
Week 12 post baseline period
Title
Timed Up and Go (TUG) test
Description
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
Title
Timed Up and Go (TUG) test
Description
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
Title
Timed Up and Go (TUG) test
Description
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
Title
Timed Up and Go (TUG) test
Description
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
Title
Timed Up and Go (TUG) test
Description
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
Title
The Blue Foam (stand) with Trek Poles Test
Description
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
Title
The Blue Foam (stand) with Trek Poles Test
Description
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
Title
The Blue Foam (stand) with Trek Poles Test
Description
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
Title
The Blue Foam (stand) with Trek Poles Test
Description
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
Title
The Blue Foam (stand) with Trek Poles Test
Description
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
Title
Parkinson's Disease Questionnaire Short Form (PDQ8)
Description
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
Title
Parkinson's Disease Questionnaire Short Form (PDQ8)
Description
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
Title
Parkinson's Disease Questionnaire Short Form (PDQ8)
Description
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
Title
Parkinson's Disease Questionnaire Short Form (PDQ8)
Description
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
Title
Parkinson's Disease Questionnaire Short Form (PDQ8)
Description
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
Title
Psychological Need Satisfaction in Exercise Scale (PNSES)
Description
Total range 1-6. Lower scores denotes worse outcome.
Time Frame
Baseline Measure 1 performed at day 1 after signing consent
Title
Psychological Need Satisfaction in Exercise Scale (PNSES)
Description
Total range 1-6. Lower scores denotes worse outcome.
Time Frame
Baseline Measure 2 performed at day 2 after signing consent
Title
Psychological Need Satisfaction in Exercise Scale (PNSES)
Description
Total range 1-6. Lower scores denotes worse outcome.
Time Frame
Week 4 post baseline period
Title
Psychological Need Satisfaction in Exercise Scale (PNSES)
Description
Total range 1-6. Lower scores denotes worse outcome.
Time Frame
Week 8 post baseline period
Title
Psychological Need Satisfaction in Exercise Scale (PNSES)
Description
Total range 1-6. Lower scores denotes worse outcome.
Time Frame
Week 12 post baseline period
Title
Perceived Stress Scale (PSS-10)
Description
Total range 0-4. Lower scores denotes worse/better outcome.
Time Frame
Baseline Measure 1 performed at day 1 after signing consent
Title
Perceived Stress Scale (PSS-10)
Description
Total range 0-4. Lower scores denotes worse/better outcome.
Time Frame
Baseline Measure 2 performed at day 2 after signing consent
Title
Perceived Stress Scale (PSS-10)
Description
Total range 0-4. Lower scores denotes worse/better outcome.
Time Frame
Week 4 post baseline period
Title
Perceived Stress Scale (PSS-10)
Description
Total range 0-4. Lower scores denotes worse/better outcome.
Time Frame
Week 8 post baseline period
Title
Perceived Stress Scale (PSS-10)
Description
Total range 0-4. Lower scores denotes worse/better outcome.
Time Frame
Week 12 post baseline period
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 3 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 4 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 5 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 6 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 7 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 8 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 9 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 10 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 11 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 12 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 13 after signing consent
Title
Pain Rating Scale
Description
10 point rating scale, low score indicates less pain.
Time Frame
completed week 14 after signing consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Cromer, LRT
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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