Clinical trial NCT05951985: High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners
Official title: High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners: A 2-Year Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Parkinson Disease
Spinal Cord Injuries
Spina Bifida
Stroke
Poliomyelitis
Multiple Sclerosis
Brain Injuries
Keywords: hift
exercise
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal with assessments occurring quarterly over the course of two years
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant Attendance at 24 months
timeFrame: After 24 months of intervention
Secondary outcomes:
measure: Change in lower extremity functional strength at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: hange in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in fast-paced gait speed at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in fast-paced wheelchair propulsion speed at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in 6 Minute Walk Test at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in 6 Minute Propulsion Test at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in accelerometer-measured moderate-to-vigorous physical activity at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Participant Retention at 24 months
timeFrame: After 24 months of intervention
measure: Participant Recruitment Rates
timeFrame: Throughout the 24 months study period
measure: Change in four square step test at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: YMCA Bench Press Test at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: 30 second peak power test at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in self-reported exercise confidence at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in self-reported pain at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in self-reported sleep quality at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in self-reported social support at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Change in self-reported physical ability at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported safety with program at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported satisfaction with coach supervision at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported feelings of inclusion at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported feelings of exercise intensity at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported feelings of exercise variety at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
measure: Self-reported feelings of exercise applicability in real life at 24 months
timeFrame: After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
References:
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.
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.
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.
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.