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临床试验/NCT05221723
NCT05221723已完成不适用

Functional Interval Training for People With Spinal Cord Injury and Their Care Partners

Arkansas Colleges of Health Education2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Participant Attendance

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Participant Attendance

时间窗: 3 months (intervention midpoint), 6 months (immediately post intervention completion)

The percentage of interventions sessions attended by participants.

次要结局

  • Change in The Spinal cord Injury Exercise Self-Efficacy Scale at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Self Efficacy for Exercise Scale at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Moderate to Vigorous Physical Activity Levels at 6 Months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Participant Recruitment Rate(Throughout the 6-month study period)
  • Change in 6-Minute Arm Test (6-MAT) at 6 Months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Five Times Sit to Stand Test at 6 Months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Upper Extremity Muscular Strength at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Social Support and Exercise Survey at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Gait Speed at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Rand 36-Item Health Survey 1.0 at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • 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(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Spinal Cord Injury - Functional Index at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in One Minute Peak Power Test at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Self-Reported Physical Activity Level at 6 Months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in lower extremity functional strength at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in 6 Minute Walk Test at 6 months(Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion))
  • Change in Global Rating of Change at 6 Months(After 6 months of exercise intervention)
  • Participant Retention(After 6 months of exercise intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaci Handlery

Assistant Professor, School of Physical Therapy

Arkansas Colleges of Health Education

研究点 (2)

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