Spinal Cord Injuries Clinical Trial
Official title:
Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury
Verified date | September 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Aerobic Capacity | 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. | baseline | |
Primary | Change in Aerobic Capacity | 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. | 16weeks post training | |
Primary | Change in Muscular Strength | Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers. | baseline | |
Primary | Change in Muscular Strength | Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers. | 16weeks post | |
Primary | Change in Insulin Sensitivity | 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. | baseline | |
Primary | Change in Insulin Sensitivity | 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. | 16weeks post training | |
Primary | Change in Blood Lipids | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | baseline | |
Primary | Change in Blood Lipids | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | 16weeks post training | |
Primary | Change in Body Composition | Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility. | baseline | |
Primary | Change in Body Composition | Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility. | 16weeks post training | |
Primary | Change in Blood Pressure | Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope. | baseline | |
Primary | Change in Blood Pressure | Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope. | 16weeks post training | |
Secondary | Semi-Structured Interview | The semi-structured interviews will contain seven open-ended questions related to the following areas: 1) overall perceptions of the program, 2) program likes, 3) dislikes, 4) perceived satisfaction and 5) value, 6) technology and equipment usability, and 7) factors that affected adherence. These areas will be probed in greater detail by the interviewer through additional follow-up questions. | 16 weeks post-training |
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