Clinical trial NCT05221723: Functional Interval Training for People With Spinal Cord Injury and Their Care Partners
Official title: Functional Interval Training for People With Spinal Cord Injury and Their Care Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
exercise
physical activity
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Functional Interval Training for People with Spinal Cord Injury and Their Care Partners (SCI-FIT) aims to address barriers to physical activity for people with spinal cord injury and their care partners. This research study provides free, twice weekly group-based, adaptable exercise classes for people with spinal cord injury and their care partners.

Detailed description: Regular physical activity, and more specifically exercise, is beneficial for people with and without spinal cord injury (SCI). Unfortunately, people with spinal cord injury (pSCI) are less physically active than adults without SCI and are at an increased risk of cardiovascular disease. Care partners, or those who provide frequent assistance to those living with SCI, also achieve low physical activity levels and share similar health risks as a result. Often there are limited opportunities for pSCI to engage in regular exercise. In addition, pSCI and their care partners often face significant barriers to exercise including 1) lack of exercise participation opportunities; 2) cost of quality exercise instruction; 3) inaccessible exercise equipment or environments; 4) lack of social support from family and peers. This study, Functional Interval Training for People with Spinal Cord Injury and Their Care Partners (SCI-FIT) will explicitly address the barriers to exercise pSCI and their care partners often face with the primary goals of improving the health, physical activity levels, and quality of life of pSCI and their care partners. In order to address these goals, SCI-FIT will provide no-cost, twice weekly, group-based, adaptable exercise programming for pSCI and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise and 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 and will undergo a battery of baseline outcome assessments prior to undergoing the exercise intervention. Participants will complete 6-months of twice weekly group exercise classes aimed and hypothesized to increase physical activity levels, muscular strength, social support for exercise, functional mobility, peak power output, aerobic capacity, and quality of life for people with spinal cord injury and their care partners. Participants will repeat baseline outcome assessments at study midpoint (3-months) and study completion (6-months).

Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury: Must have a clinical diagnosis of spinal cord injury at level C5 (ASIA A-D) and/or must possess at least 4/5 elbow flexion muscular strength
* Care Partners: self-identified care partner of a person with spinal cord injury participating in the study
* Must be at least 18 years of age
* Must be able to communicate and read in English
* Must have physician or advanced practice provider clearance to exercise
* Must provide their own transportation to and from the research study
* Must be able to ambulate independently and/or propel a power or manual wheelchair independently
* Care Partners: self-identified care partner of a person with spinal cord injury participating in the study

Exclusion Criteria:

* Less than 4/5 elbow flexion muscular strength
* Unable to ambulate independently or propel a power or manual wheelchair independently
* Unable to provide transportation to and from the research study
* Unable to communicate in English
* Unable to present documented medical clearance to exercise from physician or advanced practice provider

Primary outcomes:
measure: Participant Attendance
timeFrame: 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary outcomes:
measure: Change in 6-Minute Arm Test (6-MAT) at 6 Months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Five Times Sit to Stand Test at 6 Months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Upper Extremity Muscular Strength at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in The Spinal cord Injury Exercise Self-Efficacy Scale at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Self Efficacy for Exercise Scale at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Social Support and Exercise Survey at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Gait Speed at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Rand 36-Item Health Survey 1.0 at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Quality of Life for People with Spinal Cord Injury as assessed by the Spinal Cord Injury - Quality of Life Measure [Emotional Health and Social Participation] at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Spinal Cord Injury - Functional Index at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in One Minute Peak Power Test at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Moderate to Vigorous Physical Activity Levels at 6 Months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Participant Retention
timeFrame: After 6 months of exercise intervention
measure: Change in lower extremity functional strength at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in 6 Minute Walk Test at 6 months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Change in Global Rating of Change at 6 Months
timeFrame: After 6 months of exercise intervention
measure: Change in Self-Reported Physical Activity Level at 6 Months
timeFrame: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
measure: Participant Recruitment Rate
timeFrame: Throughout the 6-month study period
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
affiliation: Arkansas Colleges of Health Education
name: Kaci Handlery, DPT
role: PRINCIPAL_INVESTIGATOR
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