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

Spinal Cord Injuries Clinical Trial

— SCI-FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221723
• Other study ID #: PT-2021-024
• Status: Completed
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: November 24, 2022

Study information

• Verified date: June 2023
• Source: Arkansas Colleges of Health Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• High Intensity Interval Exercise Training Group
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.

Locations

Country	Name	City	State
United States	Arkansas Colleges of Health Education	Fort Smith	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Colleges of Health Education

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View Citation

LaVela SL, Landers K, Etingen B, Karalius VP, Miskevics S. Factors related to caregiving for individuals with spinal cord injury compared to caregiving for individuals with other neurologic conditions. J Spinal Cord Med. 2015 Jul;38(4):505-14. doi: 10.1179/2045772314Y.0000000240. Epub 2014 Jul 3. — View Citation

Lynch J, Cahalan R. The impact of spinal cord injury on the quality of life of primary family caregivers: a literature review. Spinal Cord. 2017 Nov;55(11):964-978. doi: 10.1038/sc.2017.56. Epub 2017 Jun 27. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Attendance	The percentage of interventions sessions attended by participants.	3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	Change in 6-Minute Arm Test (6-MAT) at 6 Months	Assessment of aerobic capacity in individuals with spinal cord injury	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	Change in Gait Speed at 6 months	Measure of walking speed at both self-selected and fast walking speed for ambulatory participants.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	Change in One Minute Peak Power Test at 6 months	Measure of peak power assessed via a 1-minute skiergometer tests	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	Participant Retention	The number and percentage of participants who remain in the study through the final measurement point at 6 months.	After 6 months of exercise intervention
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	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.	After 6 months of exercise intervention
Secondary	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".	Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)
Secondary	Participant Recruitment Rate	The number of participants recruited will be reported as a percentage of total participants contacted for study participation.	Throughout the 6-month study period