Parkinson DiseaseSHIFT-PDNCT05225506
Support + High Intensity Functional Training for Parkinson's
A study testing Exercise in people with Parkinson Disease, run by Arkansas Colleges of Health Education at 1 site in United States.
Trial summary
Parkinson's is the fastest growing neurological disorder in the world. With more people living with Parkinson's than ever before, there is an urgent need for interventions that improve health and reduce disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 24 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age
- Participants must have a diagnosis of Parkinson's disease
- Participants must be able to communicate and read in English
- Participants must have physician or advanced practice provider clearance to exercise
- Participants must provide their own transportation to and from the research study
- Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently
Show all 13Show fewer
- Inclusion criteria for people who identify as care partners of those with Parkinson's
- Participants must be at least 18 years of age
- Participants must be able to communicate and read in English
- Participants must have physician or advanced practice provider clearance to exercise
- Participants must be a self-identified care partner of a person with Parkinson's participating in the study
- Participants must provide their own transportation to and from the research study
- Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently
Who cannot join
- -Failure to meet above listed inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Colleges of Health Education
Fort Smith, Arkansas, 72916
About this study
Parkinson's is the fastest growing neurological disorder in the world. With more people living with Parkinson's than ever before, there is an urgent need for interventions that improve health and reduce disability. High intensity exercise has shown to be superior to other forms of exercise in that it can slow symptom progression. High intensity exercise also reduces the risk of cardiovascular events. This is pertinent considering one in five people with Parkinson's will die from cardiovascular disease. While Parkinson's specific exercise programs across the U.S. continue to increase, there are still many communities with limited to no access, including Fort Smith, Arkansas. Here, there are no expert level centers within 100 miles and not a single community-based exercise program. This research will offer a community and group-based exercise program for participants with Parkinson's and their care partners.
Read the detailed description
This study, Support + High Intensity Functional Training for Parkinson's (SHIFT-PD), will provide no-cost, twice weekly, group-based, adaptable exercise programming for people with Parkinson's and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise (please see attached medical release form). All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study (please see methodology section below). All eligible participants will complete a demographics questionnaire requesting participant age, sex, race/ethnicity, marital status, household income, primary means of locomotion, month and/or year of Parkinson's diagnosis (people with Parkinson's only), relationship to participant with Parkinson's (care partner only). Demographic data will be utilized to describe the study population participating in the research study and to evaluate barriers and facilitators for participation. All eligible participants will undergo a battery of baseline outcome assessments prior to undergoing the exercise intervention.
Participants will participate in a maximum of twice weekly group-based exercise classes for up to 6 months. All exercise programming will be led by licensed physical therapists at a local gym, CrossFit Fort Smith. All physical therapists will be CPR/BLS certified and an automated external defibrillator will be available onsite. Exercise classes will incorporate aerobic, resistance, and/or balance training. Exercise intensity will be monitored by participant vital signs and/or participant Rating of Perceived Exertion. SHIFT-PD will follow all state, federal, and CDC guidelines regarding COVID-19 precautions.
- Conditions
- Parkinson Disease
- Being tested
- Exercise
- Keywords
- exercise, physical activity, parkinson
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise sessions will be one hour in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on movements specifically targeting common deficits seen in Parkinson's.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | In this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Attendance at 6 months
The percentage of interventions sessions attended by participants.
Measured: After 6 months of exercise intervention
Secondary outcomes (17)
Change in lower extremity functional strength at 6 months
Lower extremity strength will be measured via functional test (Five Times Sit to Stand). This test records the amount of time taken to rise and sit to and from a chair five consecutive times. Faster times indicate greater lower extremity strength.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in grip strength at 6 months
Grip strength will be measured via hand held dynamometry. Participants will perform three trials using their dominant hand. The force of each grip will be recorded and averaged in pounds.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Activities Specific Balance Confidence (ABC) Scale at 6 months
The ABC scale is a 16-item participant-reported measure of balance confidence while performing various activities. Participants rank their level of confidence from 0 (not at all confident) to 100 (completely confident); scores from each item are then averaged for one final score. The maximum score is 100%, indicating high balance confidence.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 6 months
The PDQ-39 is a 39-item participant-reported questionnaire which assesses health-related quality of life across 8 domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Participants respond to each item using a 5-point Likert scale from 0 (never) to 4 (always). Items in each domain are scored by expressing summed item scores as a percentage (ranging from 0 to 100%). Lower scores indicate better quality of life.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Mini Balance Evaluation Systems Test (Mini BESTest) at 6 months
The Mini BESTest is a 14-item test that assesses Anticipatory balance, reactive postural control, sensory orientation and dynamic gait. Performance for each item is ranked on a 3-point ordinal scale (0,1, or 2) with a total possible score of 28 (indicating good balance).
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in fast-paced gait speed at 6 months
Fast-paced walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in casual gait speed at 6 months
Walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Social Support for Exercise Scale at 6 months
The Social Support for Exercise Scale contains 13 items and asks participants to rank frequency of supporting exercise behaviors amongst both family and friends on a 5-point Likert scale (1, none to 5, very often). Scores range from 13 to 65 with higher scores indicating greater social support for exercise.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Self efficacy for exercise scale at 6 months
The Self-Efficacy for Exercise Scale contains 9 items and asks participants to rank their confidence (0, not confident to 10, very confident) in their ability to exercise three times per week for 20 minutes in 9 different scenarios. Scores range from 0 to 90 with higher scores indicating greater exercise self-efficacy.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in 6 Minute Walk Test at 6 months
The 6 Minute Walk Test measures a participants ability to cover as much distance (measured in meters) as possible while walking for 6 minutes. Participants will walk along a pre-defined pathway for 6 minutes, resting as needed. The test is a measure of walking endurance with further distances indicating greater endurance.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Rand 36-Item Health Survey at 6 months
Health related quality of life will be measured via Rand 36-item Health Survey. This 36 item survey asks participants about their health in several categories (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health). Scores in each category are averaged and range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 6 months
The MDS-UPDRS measures disability as a result of Parkinson's and allows tracking for progression of the disease. The scale has four parts (1, mentation, behavior and mood, 2, activities of daily living, 3, motor examination, and 4, complications of therapy. Each parkinsonian sign or symptom is ranked on a 5-point Likert scale (ranging from 0 to 4) with higher scores indicating greater impairments. The minimum score on the entire scale is 0 and the maximum is 199.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Global Rating of Change at 6 Months
Participants will rate their perceived level of change on a 15-point Likert Scale ranging from -7 (a very great deal less/worse to +7 (a very great deal more/better) with 0 representing no change. They will use this scale to answer 6 separate questions: 1) amount of physical activity performed in an average week, 2) ability to walk leisurely, 3) ability to walk fast, 4) ability to walk for a long period of time, 5) ability to stand up from a seated position, 6) ability to steady yourself and prevent a fall.
Measured: After 6 months of exercise intervention (T3)
Change in Self-Reported Physical Activity Level at 6 Months
Participants report their perceived physical activity levels compared to people their own age using a 5-point Likert Scale ranging from "much more active" to "much less active".
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in accelerometer-measured moderate-to-vigorous physical activity at 6 months
Physical activity levels will be measured via thigh-worn accelerometer (activPAL). This small device will be worn on the less affected thigh (or right thigh for care partners) of participants with Parkinson's. The activPAL is able to detect acceleration and body position (i.e. sitting, standing, or lying). Through collecting acceleration data, different intensities of physical activity will be inferred (i.e light, moderate and vigorous intensity physical activity), with moderate-to-vigorous intensity physical activity being used as the primary outcome measure. At all time points, participants will wear the activPAL for 7 consecutive days. The activPAL will be waterproofed and will not need to be removed for activities such as bathing.
Measured: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Participant Retention
The number and percentage of participants who remain in the study through the final measurement point at 6 months.
Measured: After 6 months of exercise intervention (T3)
Participant Recruitment Rate
The number of participants recruited will be reported as a percentage of total participants contacted for study participation.
Measured: Throughout the 6-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Feb 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre and post test with assessments at baseline and after 3 and 6 months of intervention
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Colleges of Health Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reed Handlery, Arkansas Colleges of Health Education
- Investigators
- Reed Handlery, PhD, Principal investigator, Arkansas Colleges of Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225506
- Sponsor's protocol ID
- PT-2021-025
- Acronym
- SHIFT-PD
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benka Wallen M, Franzen E, Nero H, Hagstromer M. Levels and Patterns of Physical Activity and Sedentary Behavior in Elderly People With Mild to Moderate Parkinson Disease. Phys Ther. 2015 Aug;95(8):1135-41. doi: 10.2522/ptj.20140374. Epub 2015 Feb 5.
PubMed 25655884Pennington S, Snell K, Lee M, Walker R. The cause of death in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2010 Aug;16(7):434-7. doi: 10.1016/j.parkreldis.2010.04.010. Epub 2010 May 31.
PubMed 20570207Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
PubMed 29228079Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.
PubMed 24991037Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.
PubMed 23288910Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.
PubMed 30715489
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support + High Intensity Functional Training for Parkinson's
- ClinicalTrials.gov ID
- NCT05225506
- Acronym / sponsor ID
- SHIFT-PD / PT-2021-025
- Conditions
- Parkinson Disease
- Keywords
- exercise, physical activity, parkinson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Arkansas Colleges of Health EducationUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 4 Feb 2022 (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.
Parkinson's is the fastest growing neurological disorder in the world. With more people living with Parkinson's than ever before, there is an urgent need for interventions that improve health and reduce disability. High intensity exercise has shown to be superior to other forms of exercise in that it can slow symptom progression. High intensity exercise also reduces the risk of cardiovascular events. This is pertinent considering one in five people with Parkinson's will die from cardiovascular disease. While Parkinson's specific exercise programs across the U.S. continue to increase, there are still many communities with limited to no access, including Fort Smith, Arkansas. Here, there are no expert level centers within 100 miles and not a single community-based exercise program. This research will offer a community and group-based exercise program for participants with Parkinson's and their care partners.
Detailed description
This study, Support + High Intensity Functional Training for Parkinson's (SHIFT-PD), will provide no-cost, twice weekly, group-based, adaptable exercise programming for people with Parkinson's and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise (please see attached medical release form). All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study (please see methodology section below). All eligible participants will complete a demographics questionnaire requesting participant age, sex, race/ethnicity, marital status, household income, primary means of locomotion, month and/or year of Parkinson's diagnosis (people with Parkinson's only), relationship to participant with Parkinson's (care partner only). Demographic data will be utilized to describe the study population participating in the research study and to evaluate barriers and facilitators for participation. All eligible participants will undergo a battery of baseline outcome assessments prior to undergoing the exercise intervention.
Participants will participate in a maximum of twice weekly group-based exercise classes for up to 6 months. All exercise programming will be led by licensed physical therapists at a local gym, CrossFit Fort Smith. All physical therapists will be CPR/BLS certified and an automated external defibrillator will be available onsite. Exercise classes will incorporate aerobic, resistance, and/or balance training. Exercise intensity will be monitored by participant vital signs and/or participant Rating of Perceived Exertion. SHIFT-PD will follow all state, federal, and CDC guidelines regarding COVID-19 precautions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre and post test with assessments at baseline and after 3 and 6 months of intervention
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseIn this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must be at least 18 years of age
- Participants must have a diagnosis of Parkinson's disease
- Participants must be able to communicate and read in English
- Participants must have physician or advanced practice provider clearance to exercise
- Participants must provide their own transportation to and from the research study
Key exclusion criteria (1 listed)
- -Failure to meet above listed inclusion criteria
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 |
|---|---|---|
| ExerciseExercise sessions will be one hour in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on movements specifically targeting common deficits seen in Parkinson's. | Behavioural | Exercise |
Primary outcome
Participant Attendance at 6 months
Time frame: After 6 months of exercise intervention
The percentage of interventions sessions attended by participants.
17 secondary outcomes
Change in lower extremity functional strength at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in grip strength at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Activities Specific Balance Confidence (ABC) Scale at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Mini Balance Evaluation Systems Test (Mini BESTest) at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in fast-paced gait speed at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in casual gait speed at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Social Support for Exercise Scale at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Self efficacy for exercise scale at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in 6 Minute Walk Test at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Rand 36-Item Health Survey at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in Global Rating of Change at 6 Months
Time frame: After 6 months of exercise intervention (T3)
Change in Self-Reported Physical Activity Level at 6 Months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Change in accelerometer-measured moderate-to-vigorous physical activity at 6 months
Time frame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Participant Retention
Time frame: After 6 months of exercise intervention (T3)
Participant Recruitment Rate
Time frame: Throughout the 6-month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 25655884Benka Wallen M, Franzen E, Nero H, Hagstromer M. Levels and Patterns of Physical Activity and Sedentary Behavior in Elderly People With Mild to Moderate Parkinson Disease. Phys Ther. 2015 Aug;95(8):1135-41. doi: 10.2522/ptj.20140374. Epub 2015 Feb 5.
- Background: PubMed 20570207Pennington S, Snell K, Lee M, Walker R. The cause of death in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2010 Aug;16(7):434-7. doi: 10.1016/j.parkreldis.2010.04.010. Epub 2010 May 31.
- Background: PubMed 29228079Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
- Background: PubMed 24991037Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.
- Background: PubMed 23288910Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.
- Background: PubMed 30715489Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.
- 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.
Reed Handlery, PhD principal investigator
Arkansas Colleges of Health Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease, run by Arkansas Colleges of Health Education 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 13 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: finished, as of the sponsor's last update on 13 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant Attendance at 6 months (time frame: After 6 months of exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225506, which also lists 6 linked publications.
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 13 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.