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High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners (SHIFT-AR)

Primary Purpose

Neurologic Disorder, Parkinson Disease, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIFT
Sponsored by
Arkansas Colleges of Health Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurologic Disorder focused on measuring hift, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Participants will be excluded if they fail to meet any of the inclusion requirements

Sites / Locations

  • Arkansas Colleges of Health EducationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFT Exercise

Arm Description

In this single group design, all participants will be provided with up to two years of twice weekly supervised group exercise.

Outcomes

Primary Outcome Measures

Participant Attendance at 24 months
The percentage of intervention sessions attended by participants.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Participant Retention at 24 months
The number and percentage of participants who remain in the study through the final measurement point at 24 months.
Participant Recruitment Rates
The number of participants recruited will be reported as a percentage of total participants contacted for study participation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 11, 2023
Last Updated
September 8, 2023
Sponsor
Arkansas Colleges of Health Education
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1. Study Identification

Unique Protocol Identification Number
NCT05951985
Brief Title
High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners
Acronym
SHIFT-AR
Official Title
High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners: A 2-Year Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
August 14, 2025 (Anticipated)
Study Completion Date
August 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arkansas Colleges of Health Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Parkinson Disease, Spinal Cord Injuries, Spina Bifida, Stroke, Poliomyelitis, Multiple Sclerosis, Brain Injuries
Keywords
hift, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal with assessments occurring quarterly over the course of two years
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFT Exercise
Arm Type
Experimental
Arm Description
In this single group design, all participants will be provided with up to two years of twice weekly supervised group exercise.
Intervention Type
Behavioral
Intervention Name(s)
HIFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Attendance at 24 months
Description
The percentage of intervention sessions attended by participants.
Time Frame
After 24 months of intervention
Secondary Outcome Measure Information:
Title
Change in lower extremity functional strength at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
hange in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in fast-paced gait speed at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in fast-paced wheelchair propulsion speed at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in 6 Minute Walk Test at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in 6 Minute Propulsion Test at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in accelerometer-measured moderate-to-vigorous physical activity at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Participant Retention at 24 months
Description
The number and percentage of participants who remain in the study through the final measurement point at 24 months.
Time Frame
After 24 months of intervention
Title
Participant Recruitment Rates
Description
The number of participants recruited will be reported as a percentage of total participants contacted for study participation.
Time Frame
Throughout the 24 months study period
Title
Change in four square step test at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
YMCA Bench Press Test at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
30 second peak power test at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in self-reported exercise confidence at 24 months
Description
Change will be reported using a visual analogue scale where participants rate their confidence from not confident at all to completely confident.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in self-reported pain at 24 months
Description
Change will be reported using a visual analogue scale where participants rate their pain from no pain to worst possible pain.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in self-reported sleep quality at 24 months
Description
Change will be reported using a visual analogue scale where participants rate their sleep quality from poor to exceptional.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in self-reported social support at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Change in self-reported physical ability at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported safety with program at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported satisfaction with coach supervision at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported feelings of inclusion at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported feelings of exercise intensity at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported feelings of exercise variety at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Title
Self-reported feelings of exercise applicability in real life at 24 months
Description
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.
Time Frame
After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Participants will be excluded if they fail to meet any of the inclusion requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reed Handlery, PhD
Phone
479-401-6016
Email
reed.handlery@achehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaci Handlery, DPT
Phone
479-401-6017
Email
kaci.handlery@achehealth.edu
Facility Information:
Facility Name
Arkansas Colleges of Health Education
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reed Handlery, PhD
Phone
479-401-6016
Email
reed.handlery@achehealth.edu
First Name & Middle Initial & Last Name & Degree
Kaci Handlery, DPT
Phone
479-401-6017
Email
kaci.handlery@achehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
All non-identifiable data may be made available to other researchers upon request.
Citations:
PubMed Identifier
29228079
Citation
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.
Results Reference
background
PubMed Identifier
30715489
Citation
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.
Results Reference
background
PubMed Identifier
30087252
Citation
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.
Results Reference
background
PubMed Identifier
35927708
Citation
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.
Results Reference
background

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

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