Parkinson's DiseaseNCT04164043
Efficacy of a Recreation Therapy Wellness Recovery Program for Individuals With Parkinson's Disease
A study testing Wellness Recovery Program in people with Parkinson's Disease, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Wellness Recovery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 5 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Conditions
- Parkinson's Disease
- Being tested
- Wellness Recovery Program
- Keywords
- Recreation Therapy, Community Based, Movement Disorder, Wellness Recovery Program
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Recovery ProgramBehavioural
Also called WRP
12-week community-based recreation therapy
| Study group | Role | What they receive |
|---|---|---|
| Recreational Therapy Wellness Recovery Program Group | Experimental | 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). Receives: Behavioral: Wellness Recovery Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Measured: 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.
Measured: 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.
Measured: Week 4 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Measured: Week 8 post baseline period
Sit to Stand Test
Measures functional muscle strength in the lower limbs. This test is reported in seconds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Measured: 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.
Measured: 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.
Measured: Week 4 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Measured: Week 8 post baseline period
Psychological Need Satisfaction in Exercise Scale (PNSES)
Total range 1-6. Lower scores denotes worse outcome.
Measured: Week 12 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Measured: 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.
Measured: 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.
Measured: Week 4 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Measured: Week 8 post baseline period
Perceived Stress Scale (PSS-10)
Total range 0-4. Lower scores denotes worse/better outcome.
Measured: Week 12 post baseline period
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 3 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 4 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 5 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 6 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 7 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 8 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 9 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 10 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 11 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 12 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 13 after signing consent
Pain Rating Scale
10 point rating scale, low score indicates less pain.
Measured: completed week 14 after signing consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start6 Mar 2018
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Why it stopped: Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy Cromer, LRT, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164043
- Sponsor's protocol ID
- IRB00040793
- Status last verified
- Sep 2021
- First submitted
- 11 Nov 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Recreation Therapy Community Based Wellness Recovery Program for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04164043
- Acronym / sponsor ID
- IRB00040793
- Conditions
- Parkinson's Disease
- Keywords
- Recreation Therapy, Community Based, Movement Disorder, Wellness Recovery Program
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will enter a 14 week baseline data collection period followed by a 12-week Wellness Recovery Program
| Arm | Type | Receives |
|---|---|---|
| Recreational Therapy Wellness Recovery Program Group | Experimental | Behavioral: Wellness Recovery ProgramAll 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). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Recovery ProgramAlso: WRP12-week community-based recreation therapy | Behavioural | Recreational Therapy Wellness Recovery Program Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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.
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.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Time frame: Week 4 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Time frame: Week 8 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
Psychological Need Satisfaction in Exercise Scale (PNSES)
Time frame: Week 12 post baseline period
Total range 1-6. Lower scores denotes worse outcome.
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.
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.
Perceived Stress Scale (PSS-10)
Time frame: Week 4 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Time frame: Week 8 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Perceived Stress Scale (PSS-10)
Time frame: Week 12 post baseline period
Total range 0-4. Lower scores denotes worse/better outcome.
Pain Rating Scale
Time frame: completed week 3 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 4 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 5 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 6 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 7 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 8 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 9 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 10 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 11 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 12 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 13 after signing consent
10 point rating scale, low score indicates less pain.
Pain Rating Scale
Time frame: completed week 14 after signing consent
10 point rating scale, low score indicates less pain.
Results and safety
The study was stopped early (reason given: Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Cromer, LRT principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Recovery Program in people with Parkinson's Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision made on 8/16/2021 due to difficult enrollment because of limited access for enrollees during the pandemic and changes in staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit to Stand Test (time frame: Baseline Measure 1 performed at day 1 after signing consent). The study lists 47 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.