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

March 17, 2023 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Recreational Therapy Wellness Recovery Program Group
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
Other Names:
  • WRP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sit to Stand Test
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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
Time Frame: Week 4 post baseline period
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 4 post baseline period
Sit to Stand Test
Time Frame: Week 8 post baseline period
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 8 post baseline period
Sit to Stand Test
Time Frame: Week 12 post baseline period
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Week 12 post baseline period
Timed Floor Transfer Test
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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
Timed Floor Transfer Test
Time Frame: Week 4 post baseline period
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
Time Frame: Week 8 post baseline period
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
Time Frame: Week 12 post baseline period
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
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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
Time Frame: Week 4 post baseline period
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
Time Frame: Week 8 post baseline period
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
Time Frame: Week 12 post baseline period
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
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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
Time Frame: Week 4 post baseline period
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
Time Frame: Week 8 post baseline period
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
Time Frame: Week 12 post baseline period
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)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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)
Time Frame: Week 4 post baseline period
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)
Time Frame: Week 8 post baseline period
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)
Time Frame: Week 12 post baseline period
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)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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)
Time Frame: Week 4 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
Week 4 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Week 8 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
Week 8 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame: Week 12 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
Week 12 post baseline period
Perceived Stress Scale (PSS-10)
Time Frame: Baseline Measure 1 performed at day 1 after signing consent
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)
Time Frame: Baseline Measure 2 performed at day 2 after signing consent
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)
Time Frame: Week 4 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Week 4 post baseline period
Perceived Stress Scale (PSS-10)
Time Frame: Week 8 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Week 8 post baseline period
Perceived Stress Scale (PSS-10)
Time Frame: Week 12 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Week 12 post baseline period
Pain Rating Scale
Time Frame: completed week 3 after signing consent
10 point rating scale, low score indicates less pain.
completed week 3 after signing consent
Pain Rating Scale
Time Frame: completed week 4 after signing consent
10 point rating scale, low score indicates less pain.
completed week 4 after signing consent
Pain Rating Scale
Time Frame: completed week 5 after signing consent
10 point rating scale, low score indicates less pain.
completed week 5 after signing consent
Pain Rating Scale
Time Frame: completed week 6 after signing consent
10 point rating scale, low score indicates less pain.
completed week 6 after signing consent
Pain Rating Scale
Time Frame: completed week 7 after signing consent
10 point rating scale, low score indicates less pain.
completed week 7 after signing consent
Pain Rating Scale
Time Frame: completed week 8 after signing consent
10 point rating scale, low score indicates less pain.
completed week 8 after signing consent
Pain Rating Scale
Time Frame: completed week 9 after signing consent
10 point rating scale, low score indicates less pain.
completed week 9 after signing consent
Pain Rating Scale
Time Frame: completed week 10 after signing consent
10 point rating scale, low score indicates less pain.
completed week 10 after signing consent
Pain Rating Scale
Time Frame: completed week 11 after signing consent
10 point rating scale, low score indicates less pain.
completed week 11 after signing consent
Pain Rating Scale
Time Frame: completed week 12 after signing consent
10 point rating scale, low score indicates less pain.
completed week 12 after signing consent
Pain Rating Scale
Time Frame: completed week 13 after signing consent
10 point rating scale, low score indicates less pain.
completed week 13 after signing consent
Pain Rating Scale
Time Frame: completed week 14 after signing consent
10 point rating scale, low score indicates less pain.
completed week 14 after signing consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peggy Cromer, LRT, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00040793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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