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Clinical Trials/NCT05951985
NCT05951985
Completed
Not Applicable

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

Arkansas Colleges of Health Education1 site in 1 country100 target enrollmentAugust 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurologic Disorder
Sponsor
Arkansas Colleges of Health Education
Enrollment
100
Locations
1
Primary Endpoint
Participant Attendance at 24 months
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2023
End Date
August 14, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reed Handlery

Assistant Professor

Arkansas Colleges of Health Education

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

Outcomes

Primary Outcomes

Participant Attendance at 24 months

Time Frame: After 24 months of intervention

The percentage of intervention sessions attended by participants.

Secondary Outcomes

  • Change in 6 Minute Walk Test at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • YMCA Bench Press Test at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported satisfaction with coach supervision at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • hange in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in lower extremity functional strength at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in fast-paced wheelchair propulsion speed at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in 6 Minute Propulsion Test at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in self-reported exercise confidence at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in self-reported pain at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in self-reported sleep quality at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Participant Retention at 24 months(After 24 months of intervention)
  • Participant Recruitment Rates(Throughout the 24 months study period)
  • Change in self-reported physical ability at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported feelings of exercise intensity at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in fast-paced gait speed at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in accelerometer-measured moderate-to-vigorous physical activity at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in four square step test at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • 30 second peak power test at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Change in self-reported social support at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported feelings of inclusion at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported safety with program at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported feelings of exercise variety at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)
  • Self-reported feelings of exercise applicability in real life at 24 months(After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention)

Study Sites (1)

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