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Spinal Cord InjuriesSCI-FITNCT05221723

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

A study testing High Intensity Interval Exercise Training Group in people with Spinal Cord Injuries, run by Arkansas Colleges of Health Education at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
High Intensity Interval Exercise Training Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
18 Feb 2022to 24 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arkansas Colleges of Health Education

    Fort Smith, Arkansas, 72916

Other trials in United States

About this study

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.

Read the 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).

Being tested
High Intensity Interval Exercise Training Group
Keywords
spinal cord injury, exercise, physical activity
Medical subject headings
Spinal Cord Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval Exercise Training GroupBehavioural

    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.

Study groups in NCT05221723
Study groupRoleWhat they receive
Exercise GroupExperimentalIn this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise.
Receives: Behavioral: High Intensity Interval Exercise Training Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Attendance

    The percentage of interventions sessions attended by participants.

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

Secondary outcomes (18)

  1. Change in 6-Minute Arm Test (6-MAT) at 6 Months

    Assessment of aerobic capacity in individuals with spinal cord injury

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  2. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  3. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  4. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  5. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  6. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  7. Change in Gait Speed at 6 months

    Measure of walking speed at both self-selected and fast walking speed for ambulatory participants.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  8. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  9. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  10. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  11. Change in One Minute Peak Power Test at 6 months

    Measure of peak power assessed via a 1-minute skiergometer tests

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  12. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  13. Participant Retention

    The number and percentage of participants who remain in the study through the final measurement point at 6 months.

    Measured: After 6 months of exercise intervention

  14. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  15. 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.

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  16. 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.

    Measured: After 6 months of exercise intervention

  17. 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".

    Measured: Baseline, 3 months (intervention midpoint), 6 months (immediately post intervention completion)

  18. Participant Recruitment Rate

    The number of participants recruited will be reported as a percentage of total participants contacted for study participation.

    Measured: Throughout the 6-month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start18 Feb 2022
  3. Primary completion24 Nov 2022
  4. Study completion24 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05221723
Sponsor's protocol ID
PT-2021-024
Acronym
SCI-FIT
Status last verified
Jun 2023
First submitted
9 Jan 2022
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17398251

  • 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.

    PubMed 27530605

  • 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.

    PubMed 27363732

  • 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.

    PubMed 20093326

  • 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.

    PubMed 26010962

  • 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.

    PubMed 26108561

  • 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.

    PubMed 12494319

  • 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.

    PubMed 16386165

  • 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.

    PubMed 15685263

  • 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.

    PubMed 19841634

  • 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.

    PubMed 28653672

  • 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.

    PubMed 24993244

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Exercise Training Group in people with Spinal Cord Injuries, run by Arkansas Colleges of Health Education at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Attendance (time frame: 3 months (intervention midpoint), 6 months (immediately post intervention completion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05221723, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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