High Intensity Interval Exercise SCI

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Cardiometabolic Diseases
• Interventions: Other: high intensity interval exercise; Other: No-exercise control group

• Registration Number: NCT04940598
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-25
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Results First Submitted: 2024-05-09
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Results First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval exercise	high intensity interval exercise	High intensity interval arm crank exercise
No-Exercise Control	No-exercise control group	No-exercise control group

Primary Outcome Measures

Name	Time	Method
Body Composition Week 16	16weeks post training	Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
LDL Week 16	16-weeks post training	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Matsuda Index Baseline	baseline	Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Matsuda Index Week 16	16weeks post training	Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Cholesterol Week 16	16weeks post training	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Body Composition Baseline	baseline	Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
HDL Baseline	Baseline	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Cholesterol Baseline	baseline	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
HDL Week 16	16-weeks post training	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Aerobic Capacity Baseline	baseline	All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Aerobic Capacity Week 16	16weeks post training	All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Triglycerides Baseline	baseline	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Triglycerides Week 16	16-weeks post	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
LDL Baseline	Baseline	Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States