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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT05225506
Study groupRoleWhat they receive
ExerciseExperimentalIn 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.

  1. Participant Attendance at 6 months

    The percentage of interventions sessions attended by participants.

    Measured: After 6 months of exercise intervention

Secondary outcomes (17)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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.

  1. First posted4 Feb 2022
  2. Study start21 Feb 2022
  3. Primary completion24 Nov 2022
  4. Study completion24 Nov 2022

Resources

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)
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 25655884
  • Pennington 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 20570207
  • Schenkman 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 29228079
  • Uc 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 24991037
  • Ellis 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 23288910
  • Ellis 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

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.

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