AzTrials
AzTrials

Neurologic DisorderSHIFT-ARNCT05951985

High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners

A study testing HIFT in people with Neurologic Disorder and 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
Search all trials

Trial summary

Individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
HIFT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
15 Aug 2023to 14 Aug 2025
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 be able to communicate and read in English
  • Participants must have physician and/or advanced practice provider clearance to exercise
  • Participants must have a neurologic diagnosis (e.g., spinal cord injury, Parkinson's, brain injury, stroke, poliomyelitis, multiple sclerosis, spina bifida, etc.) OR participants must be care partner of a person with neurologic diagnosis.
  • Participants must possess at least 4/5 elbow flexion strength bilaterally
  • Participants must be able to locomote independently (i.e., ambulate or propel a manual or power wheelchair independently).
  • Participants must provide their own transportation to/from the research study

Who cannot join

  • Participants will be excluded if they fail to meet any of the inclusion requirements

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

Official title: High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners: A 2-Year Longitudinal Study

Individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.

Read the detailed description

Over the course of two years, this study will provide no-cost, twice weekly, group-based, HIFT exercise for people with neurologic diagnoses and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise. All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study. All eligible participants will complete a demographics questionnaire, questionnaires regarding physical and psychosocial health, and a battery of physical tests assessing mobility, strength, endurance, and balance. Participants' physical activity levels will also be monitored throughout the study through accelerometers.

Participants will participate in a maximum of twice weekly HIFT exercise for up to 2 years. All exercise programming will be led by licensed physical therapists with assistance from Doctor of Physical Therapy students. All exercise staff will be Cardiopulmonary resuscitation/basic life support certified and an automated external defibrillator will be available onsite. Exercise classes will utilize HIFT, which includes various exercises that are functional and to be performed at a high intensity. Exercises will include aerobic, resistance, and/or balance training and align with the 2018 Physical Activity Guidelines for Americans.

Being tested
HIFT
Keywords
hift, exercise
Medical subject headings
Nervous System Diseases, Parkinson Disease, Spinal Cord Injuries, Spinal Dysraphism, Stroke, Poliomyelitis, Multiple Sclerosis, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIFTBehavioural

    Exercise sessions will be 60 to 75 minutes in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on functional movements performed at a high intensity. Exercises will be tailored/modified to meet the needs of each participant.

Study groups in NCT05951985
Study groupRoleWhat they receive
HIFT ExerciseExperimentalIn this single group design, all participants will be provided with up to two years of twice weekly supervised group exercise.
Receives: Behavioral: HIFT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Attendance at 24 months

    The percentage of intervention sessions attended by participants.

    Measured: After 24 months of intervention

Secondary outcomes (24)
  1. Change in lower extremity functional strength at 24 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: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  2. hange in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 24 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: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  3. Change in fast-paced gait speed at 24 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; two trials are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  4. Change in fast-paced wheelchair propulsion speed at 24 months

    Fast-paced propulsion speed will be measured via wheelchair propulsion test, which has individuals propel 10 meters and are timed; two trials are performed and the average time is taken. Faster propulsion speeds indicate greater mobility with wheelchair propulsion.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  5. Change in 6 Minute Walk Test at 24 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: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  6. Change in 6 Minute Propulsion Test at 24 months

    The 6 Minute Propulsion Test measures a participants ability to cover as much distance (measured in meters) as possible while propelling a wheelchair for 6 minutes. The test is a measure of aerobic endurance with further distances indicating greater endurance.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  7. Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 24 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: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  8. Change in accelerometer-measured moderate-to-vigorous physical activity at 24 months

    Physical activity levels will be measured via thigh or wrist-worn accelerometer (activPAL or ActiGraph). These small devices will be worn on the less affected thigh or wrist (or non-dominant thigh or wrist for care partners). 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 accelerometer for 7 consecutive days.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  9. Participant Retention at 24 months

    The number and percentage of participants who remain in the study through the final measurement point at 24 months.

    Measured: After 24 months of intervention

  10. Participant Recruitment Rates

    The number of participants recruited will be reported as a percentage of total participants contacted for study participation.

    Measured: Throughout the 24 months study period

  11. Change in four square step test at 24 months

    The four square step test measures stepping balance as the time taken to step clockwise and counterclockwise in a square pattern. Faster times indicate greater balance.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  12. YMCA Bench Press Test at 24 months

    The YMCA Bench Press Test measures muscular endurance of the upper body. The test requires participants to complete as many repetitions of barbell bench press as they can with good form. Greater number of repetitions indicates greater muscular endurance.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  13. 30 second peak power test at 24 months

    The 30 second peak power test measures anaerobic power produced (in watts) over 30 seconds on a ski ergometer. Greater wattage indicates greater anaerobic power.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  14. Change in self-reported exercise confidence at 24 months

    Change will be reported using a visual analogue scale where participants rate their confidence from not confident at all to completely confident.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  15. Change in self-reported pain at 24 months

    Change will be reported using a visual analogue scale where participants rate their pain from no pain to worst possible pain.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  16. Change in self-reported sleep quality at 24 months

    Change will be reported using a visual analogue scale where participants rate their sleep quality from poor to exceptional.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  17. Change in self-reported social support at 24 months

    Change will be reported using a visual analogue scale where participants rate their level of social support from people in the intervention and those outside the intervention. The scale goes from poor to exceptional social support.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  18. Change in self-reported physical ability at 24 months

    Change will be reported using a visual analogue scale where participants rate their level of ability from poor to exceptional on attributes of mobility, power, endurance/stamina, strength and balance.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  19. Self-reported safety with program at 24 months

    Using a visual analogue scale, participants rate their feelings of safety with the intervention at 24 months. Scores range from not safe at all to exceptionally safe.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  20. Self-reported satisfaction with coach supervision at 24 months

    Using a visual analogue scale, participants rate their feelings of satisfaction with coach supervision during the intervention at 24 months. Scores range from not satisfied at all to extremely satisfied.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  21. Self-reported feelings of inclusion at 24 months

    Using a visual analogue scale, participants rate their feelings of inclusion during the intervention at 24 months. Scores range from minimally included to maximally included.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  22. Self-reported feelings of exercise intensity at 24 months

    Using a visual analogue scale, participants rate their feelings of exercise intensity during the intervention at 24 months. Scores range from low intensity to high intensity exercise.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  23. Self-reported feelings of exercise variety at 24 months

    Using a visual analogue scale, participants rate their feelings on exercise variety during the intervention at 24 months. Scores range from low exercise variety to high exercise variety.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  24. Self-reported feelings of exercise applicability in real life at 24 months

    Using a visual analogue scale, participants rate their feelings on applicability of exercises to real life during the intervention at 24 months. Scores range from not applicable at all to extremely applicable.

    Measured: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start15 Aug 2023
  3. Primary completion14 Jul 2025
  4. Study completion14 Aug 2025

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
Longitudinal with assessments occurring quarterly over the course of two years
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951985
Sponsor's protocol ID
ACHE-2023-0114
Acronym
SHIFT-AR
Status last verified
Aug 2025
First submitted
11 Jul 2023
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All non-identifiable data may be made available to other researchers upon request.

Publications

  • 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
  • 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
  • Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

    PubMed 30087252
  • Adams J, Lai B, Rimmer J, Powell D, Yarar-Fisher C, Oster RA, Fisher G. Telehealth high-intensity interval exercise and cardiometabolic health in spinal cord injury. Trials. 2022 Aug 4;23(1):633. doi: 10.1186/s13063-022-06585-2.

    PubMed 35927708

Questions about this trial

What is this clinical trial studying?

A study testing HIFT in people with Neurologic Disorder and 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 7 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 22 Aug 2025. 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 24 months (time frame: After 24 months of 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 NCT05951985, which also lists 4 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 22 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in