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

NCT ID: NCT05221723

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-11-24

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).

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Group

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

Group Type: EXPERIMENTAL

High Intensity Interval Exercise Training Group

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Colleges of Health Education

OTHER

Sponsor Role: lead

Responsible Party

Kaci Handlery

Assistant Professor, School of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaci Handlery, DPT

Role: PRINCIPAL_INVESTIGATOR

Arkansas Colleges of Health Education

Locations

Arkansas Colleges of Health Education

Fort Smith, Arkansas, United States

Countries

United States

References

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Other Identifiers

PT-2021-024

Identifier Type: -

Identifier Source: org_study_id