Clinical trial NCT04940598: High Intensity Interval Exercise SCI
Official title: Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Cardiometabolic Diseases
Keywords: High Intensity Interval Training
Telehealth Exercise
Armcrank Exercise
SCI
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-06-25
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a longitudinal study design, 40 participants with chronic SCI will be randomly assigned to one of the two study groups (HIIT and control) in a 1:1 ratio. Randomization will be performed using the block randomization method, Randomization will be performed using the block randomization method. A randomization list will be generated and assignments will be placed into closed envelopes and given to each study participant. Participants will be assessed at baseline and 16-wks post HIIT or control
Primary purpose: PREVENTION

Brief summary: This study will determine if the implementation of a home-based telehealth high intensity interval exercise-training (HIIT)program can significantly improve cardiometabolic health and physical function in a cohort of individuals with longstanding spinal cord injury (SCI). Results from this study will determine feasibility, overall enjoyment, and health impact of implementing a home-based telehealth HIIT program in individuals with SCI.

Detailed description: For individuals with spinal cord injury (SCI), exercise participation reduces the risk of developing chronic cardiometabolic diseases, which are leading causes of rehospitalization and death within this population. Accordingly, recent SCI exercise guidelines have highlighted a need for exercise trials that can improve cardiometabolic factors such as glucose tolerance, blood lipids, blood pressure, and body composition. However, to date, the number of exercise trials examining these cardiometabolic outcomes in SCI is low, and these exercise regimens are often inconvenient for individuals with SCI to perform within their community. In addition to the functional impairment associated with the disability, individuals with SCI experience a number of barriers to exercise participation, such as lack of time (e.g. conflict with work schedule), accessible or usable equipment and facilities, and transportation. Thus, it is important to identify effective modes of exercise that can improve overall health but do not require a significant overall weekly time commitment. Investigators recently demonstrated that individuals with SCI could safely perform high intensity interval training (HIIT) using arm crank cycling and that as few as two days per week of HIIT could improve cardiometabolic health. Despite the advantages of HIIT, it is important to identify methods of implementing exercise trials that can successfully reach and maintain participation in larger cohorts. Recent work by the investigative group demonstrated that individuals with SCI expressed favorable perceptions of home-exercise training that incorporated telehealth technology, which allowed a fitness specialist to remotely monitor participants' training progress in real-time and provide verbal support via videoconferencing. This method of training holds even greater value for home-exercise programs that require monitoring to dose-specific protocols such as HIIT. However, the long-term success of HIIT will greatly depend on the ease at which the program can be implemented, as well as participants' adherence and perceptions of using the technology, which has not been investigated in SCI. The goal of this study is to integrate a home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess changes in cardiometabolic health and physical function. The secondary goal is to explore the uptake and implementation of HIIT in SCI. 40 participants will be randomized to home-based HIIT exercise or a no-exercise control group for 16-weeks. Body composition, aerobic fitness, muscular strength, and changes in cardiometabolic health will be assessed at baseline and 16-weeks post training. In addition to changes in cardiometabolic health outcomes, the investigators will also conduct interviews with participants to determine overall perceptions of the program, program likes and dislikes, perceived satisfaction and value, usability of equipment and technology, and factors that influence adherence.

Eligibility criteria: Inclusion Criteria:

1. Men and women, 19-65 years of age.
2. Confirmed diagnosis of traumatic SCI at the cervical or thoracic level (C7-T12), classified as A, B, C, or D (motor and sensory complete or incomplete) on the AIS scale.
3. At least 6 months post-injury.
4. Able to independently operate an arm ergometer.
5. Have access to a wireless internet connection.
6. Medically stable, able to provide informed consent.

Exclusion Criteria:

1. Cardiovascular or renal diseases.
2. Pregnant women
3. Orthopedic conditions that prevents arm ergomtery
4. Upper extremity musculoskeletal conditions that prevents arm ergometry.
5. Neurological disorder that prevents arm ergometry
6. Participation in a structured exercise program currently or in the past 3 months.
7. Unable to perform exercise interventions

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Primary outcomes:
measure: Aerobic Capacity Baseline
timeFrame: baseline
measure: Aerobic Capacity Week 16
timeFrame: 16weeks post training
measure: Matsuda Index Baseline
timeFrame: baseline
measure: Matsuda Index Week 16
timeFrame: 16weeks post training
measure: Cholesterol Baseline
timeFrame: baseline
measure: Cholesterol Week 16
timeFrame: 16weeks post training
measure: Body Composition Baseline
timeFrame: baseline
measure: Body Composition Week 16
timeFrame: 16weeks post training
measure: Triglycerides Baseline
timeFrame: baseline
measure: Triglycerides Week 16
timeFrame: 16-weeks post
measure: HDL Baseline
timeFrame: Baseline
measure: HDL Week 16
timeFrame: 16-weeks post training
measure: LDL Baseline
timeFrame: Baseline
measure: LDL Week 16
timeFrame: 16-weeks post training
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gordon Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams J, Lai B, Rimmer J, Powell D, Yarar-Fisher C, Oster RA, Fisher G. Telehealth high-intensity interval exercise and cardiometabolic health in spinal cord injury. Trials. 2022 Aug 4;23(1):633. doi: 10.1186/s13063-022-06585-2.