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

NCT05221723 | Completed

• 1 other identifier: PT-2021-024
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; exercise; physical activity

Outcome Measures

Primary Outcomes (1)

• Participant Attendance

  The percentage of interventions sessions attended by participants.

  3 months (intervention midpoint), 6 months (immediately post intervention completion)

Secondary Outcomes (18)

• 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 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)

Study Arms (1)

Exercise Group

EXPERIMENTAL

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

Behavioral: High Intensity Interval Exercise Training Group

Interventions

High Intensity Interval Exercise Training Group BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Colleges of Health Education: lead

Study Sites (1)

Arkansas Colleges of Health Education

Fort Smith, Arkansas, 72916, United States

Location

Related Publications (12)

• 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.

  PMID: 17398251 BACKGROUND

• 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.

  PMID: 27530605 BACKGROUND

• 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.

  PMID: 27363732 BACKGROUND

• 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.

  PMID: 20093326 BACKGROUND

• 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.

  PMID: 26010962 BACKGROUND

• 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.

  PMID: 26108561 BACKGROUND

• 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.

  PMID: 12494319 BACKGROUND

• 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.

  PMID: 16386165 BACKGROUND

• 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.

  PMID: 15685263 BACKGROUND

• 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.

  PMID: 19841634 BACKGROUND

• 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.

  PMID: 28653672 BACKGROUND

• 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.

  PMID: 24993244 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Kaci Handlery, DPT

  Arkansas Colleges of Health Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Physical Therapy

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 3, 2022
• Study Start: February 18, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)