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Functional Interval Training for People With Spinal Cord Injury and Their Care Partners (SCI-FIT)

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Exercise Training Group
Sponsored by
Arkansas Colleges of Health Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, exercise, physical activity

Eligibility Criteria

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

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

Sites / Locations

  • Arkansas Colleges of Health Education

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Group

Arm Description

In this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise.

Outcomes

Primary Outcome Measures

Participant Attendance
The percentage of interventions sessions attended by participants.

Secondary Outcome Measures

Change in 6-Minute Arm Test (6-MAT) at 6 Months
Assessment of aerobic capacity in individuals with spinal cord injury
Change in Five Times Sit to Stand Test at 6 Months
Participants who are able to stand will complete this assessment of lower extremity strength over three trials.
Change in Upper Extremity Muscular Strength at 6 months
Muscular strength of the upper extremities will be assessed via 3-trials of hand-held dynamometry of the shoulder flexor, shoulder extensor, elbow flexor and elbow extensor muscle groups as well as grip strength via a dynamometer.
Change in The Spinal cord Injury Exercise Self-Efficacy Scale at 6 months
Measures perceived self-efficacy for various types of physical activities for people with spinal cord injury. The scale has a minimum score of 10 and a maximum score of 40. Higher scores indicate greater confidence in planning and carrying out physical activities and/or exercise based on their own volition.
Change in Self Efficacy for Exercise Scale at 6 months
Self report measure for exercise self efficacy completed by care partner participants. The minimum score is 0 and maximum score is 90. A higher score indicates higher self-efficacy for exercise.
Change in Social Support and Exercise Survey at 6 months
Self report measure for social support for exercise from family and friends. The scale has a minimum score of 46 and maximum score of 230. Higher scores indicate greater social support of friends and family for physical activity and exercise behaviors.
Change in Gait Speed at 6 months
Measure of walking speed at both self-selected and fast walking speed for ambulatory participants.
Change in Rand 36-Item Health Survey 1.0 at 6 months
Self-reported measure of health related quality of life for participants who are care partners. The measure assesses eight health concepts through eight subscales (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions). Scores in each category are averaged and range from 0 to 100, with higher scores indicating better health-related quality of life.
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
Self report measure of quality of life related to Emotional Health (positive affect and well-being, resilience, self-esteem, and stigma) and Social Participation (independence) for people with spinal cord injury.
Change in Spinal Cord Injury - Functional Index at 6 months
Self report measure of perceived functional abilities of people with spinal cord injury including self-care, basic mobility, ambulation, manual wheelchair, power wheelchair, and ambulation.
Change in One Minute Peak Power Test at 6 months
Measure of peak power assessed via a 1-minute skiergometer tests
Change in Moderate to Vigorous Physical Activity Levels at 6 Months
Physical activity levels will be measured via wrist worn Actigraph GT9X Link. The Actigraph is able to detect acceleration in multiple planes of motion. 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 the four time points, participants will wear the Actigraph for 7 consecutive days. The Actigraph will not need to be removed for activities such as bathing and showering, however the device will be removed for activities such as swimming.
Participant Retention
The number and percentage of participants who remain in the study through the final measurement point at 6 months.
Change in lower extremity functional strength at 6 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.
Change in 6 Minute Walk Test at 6 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 Global Rating of Change at 6 Months
Participants will rate their perceived level of change on a 15-point Likert Scale ranging from -7 (a very great deal less/worse to +7 (a very great deal more/better) with 0 representing no change. They will use this scale to answer 4 separate questions: 1) amount of physical activity performed in an average week, 2) ability to walk or push leisurely, 3) ability to walk or push fast, 4) ability to walk or push for a long period of time.
Change in Self-Reported Physical Activity Level at 6 Months
Participants report their perceived physical activity levels compared to people their own age using a 5-point Likert Scale ranging from "much more active" to "much less active".
Participant Recruitment Rate
The number of participants recruited will be reported as a percentage of total participants contacted for study participation.

Full Information

First Posted
January 9, 2022
Last Updated
June 5, 2023
Sponsor
Arkansas Colleges of Health Education
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1. Study Identification

Unique Protocol Identification Number
NCT05221723
Brief Title
Functional Interval Training for People With Spinal Cord Injury and Their Care Partners
Acronym
SCI-FIT
Official Title
Functional Interval Training for People With Spinal Cord Injury and Their Care Partners
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, exercise, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
In this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Exercise Training Group
Intervention Description
Participants will participate in a maximum of twice weekly exercise classes (90 minutes each class) for a total of 6 months. While participants will be encouraged to attend as many classes as able, there is no minimum requirement for class attendance. During the exercise classes, participants will participate in a 10-minute warm up, followed by 30-60 minutes of aerobic, resistance and/or balance training up to a maximum intensity of 8/10 on the rating of perceived exertion scale. Participants will finish each class with a 10-minute cool-down consisting of lower intensity exercise.
Primary Outcome Measure Information:
Title
Participant Attendance
Description
The percentage of interventions sessions attended by participants.
Time Frame
3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary Outcome Measure Information:
Title
Change in 6-Minute Arm Test (6-MAT) at 6 Months
Description
Assessment of aerobic capacity in individuals with spinal cord injury
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Five Times Sit to Stand Test at 6 Months
Description
Participants who are able to stand will complete this assessment of lower extremity strength over three trials.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Upper Extremity Muscular Strength at 6 months
Description
Muscular strength of the upper extremities will be assessed via 3-trials of hand-held dynamometry of the shoulder flexor, shoulder extensor, elbow flexor and elbow extensor muscle groups as well as grip strength via a dynamometer.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in The Spinal cord Injury Exercise Self-Efficacy Scale at 6 months
Description
Measures perceived self-efficacy for various types of physical activities for people with spinal cord injury. The scale has a minimum score of 10 and a maximum score of 40. Higher scores indicate greater confidence in planning and carrying out physical activities and/or exercise based on their own volition.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Self Efficacy for Exercise Scale at 6 months
Description
Self report measure for exercise self efficacy completed by care partner participants. The minimum score is 0 and maximum score is 90. A higher score indicates higher self-efficacy for exercise.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Social Support and Exercise Survey at 6 months
Description
Self report measure for social support for exercise from family and friends. The scale has a minimum score of 46 and maximum score of 230. Higher scores indicate greater social support of friends and family for physical activity and exercise behaviors.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Gait Speed at 6 months
Description
Measure of walking speed at both self-selected and fast walking speed for ambulatory participants.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Rand 36-Item Health Survey 1.0 at 6 months
Description
Self-reported measure of health related quality of life for participants who are care partners. The measure assesses eight health concepts through eight subscales (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions). Scores in each category are averaged and range from 0 to 100, with higher scores indicating better health-related quality of life.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
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
Description
Self report measure of quality of life related to Emotional Health (positive affect and well-being, resilience, self-esteem, and stigma) and Social Participation (independence) for people with spinal cord injury.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Spinal Cord Injury - Functional Index at 6 months
Description
Self report measure of perceived functional abilities of people with spinal cord injury including self-care, basic mobility, ambulation, manual wheelchair, power wheelchair, and ambulation.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in One Minute Peak Power Test at 6 months
Description
Measure of peak power assessed via a 1-minute skiergometer tests
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Moderate to Vigorous Physical Activity Levels at 6 Months
Description
Physical activity levels will be measured via wrist worn Actigraph GT9X Link. The Actigraph is able to detect acceleration in multiple planes of motion. 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 the four time points, participants will wear the Actigraph for 7 consecutive days. The Actigraph will not need to be removed for activities such as bathing and showering, however the device will be removed for activities such as swimming.
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Participant Retention
Description
The number and percentage of participants who remain in the study through the final measurement point at 6 months.
Time Frame
After 6 months of exercise intervention
Title
Change in lower extremity functional strength at 6 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
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in 6 Minute Walk Test at 6 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
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Change in Global Rating of Change at 6 Months
Description
Participants will rate their perceived level of change on a 15-point Likert Scale ranging from -7 (a very great deal less/worse to +7 (a very great deal more/better) with 0 representing no change. They will use this scale to answer 4 separate questions: 1) amount of physical activity performed in an average week, 2) ability to walk or push leisurely, 3) ability to walk or push fast, 4) ability to walk or push for a long period of time.
Time Frame
After 6 months of exercise intervention
Title
Change in Self-Reported Physical Activity Level at 6 Months
Description
Participants report their perceived physical activity levels compared to people their own age using a 5-point Likert Scale ranging from "much more active" to "much less active".
Time Frame
Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Title
Participant Recruitment Rate
Description
The number of participants recruited will be reported as a percentage of total participants contacted for study participation.
Time Frame
Throughout the 6-month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaci Handlery, DPT
Organizational Affiliation
Arkansas Colleges of Health Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Colleges of Health Education
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17398251
Citation
Hol AT, Eng JJ, Miller WC, Sproule S, Krassioukov AV. Reliability and validity of the six-minute arm test for the evaluation of cardiovascular fitness in people with spinal cord injury. Arch Phys Med Rehabil. 2007 Apr;88(4):489-95. doi: 10.1016/j.apmr.2006.12.044.
Results Reference
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PubMed Identifier
27530605
Citation
Murray D, Hardiman O, Campion A, Vance R, Horgan F, Meldrum D. The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in Polio survivors: a randomised controlled trial. Clin Rehabil. 2017 Jul;31(7):913-925. doi: 10.1177/0269215516661225. Epub 2016 Aug 16.
Results Reference
background
PubMed Identifier
27363732
Citation
Totosy de Zepetnek JO, Au JS, Hol AT, Eng JJ, MacDonald MJ. Predicting peak oxygen uptake from submaximal exercise after spinal cord injury. Appl Physiol Nutr Metab. 2016 Jul;41(7):775-81. doi: 10.1139/apnm-2015-0670. Epub 2016 Mar 15.
Results Reference
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PubMed Identifier
20093326
Citation
Tawashy AE, Eng JJ, Krassioukov AV, Miller WC, Sproule S. Aerobic exercise during early rehabilitation for cervical spinal cord injury. Phys Ther. 2010 Mar;90(3):427-37. doi: 10.2522/ptj.20090023. Epub 2010 Jan 21.
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PubMed Identifier
26010962
Citation
Tulsky DS, Kisala PA, Victorson D, Tate DG, Heinemann AW, Charlifue S, Kirshblum SC, Fyffe D, Gershon R, Spungen AM, Bombardier CH, Dyson-Hudson TA, Amtmann D, Kalpakjian CZ, Choi SW, Jette AM, Forchheimer M, Cella D. Overview of the Spinal Cord Injury--Quality of Life (SCI-QOL) measurement system. J Spinal Cord Med. 2015 May;38(3):257-69. doi: 10.1179/2045772315Y.0000000023.
Results Reference
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PubMed Identifier
26108561
Citation
Crane DA, Hoffman JM, Reyes MR. Benefits of an exercise wellness program after spinal cord injury. J Spinal Cord Med. 2017 Mar;40(2):154-158. doi: 10.1179/2045772315Y.0000000038. Epub 2015 Jun 25.
Results Reference
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PubMed Identifier
12494319
Citation
Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.
Results Reference
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PubMed Identifier
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Citation
Nash MS. Exercise as a health-promoting activity following spinal cord injury. J Neurol Phys Ther. 2005 Jun;29(2):87-103, 106. doi: 10.1097/01.npt.0000282514.94093.c6.
Results Reference
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PubMed Identifier
15685263
Citation
Post MW, Bloemen J, de Witte LP. Burden of support for partners of persons with spinal cord injuries. Spinal Cord. 2005 May;43(5):311-9. doi: 10.1038/sj.sc.3101704.
Results Reference
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Citation
Anneken V, Hanssen-Doose A, Hirschfeld S, Scheuer T, Thietje R. Influence of physical exercise on quality of life in individuals with spinal cord injury. Spinal Cord. 2010 May;48(5):393-9. doi: 10.1038/sc.2009.137. Epub 2009 Oct 20.
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Citation
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Results Reference
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Functional Interval Training for People With Spinal Cord Injury and Their Care Partners

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