High Intensity Interval Exercise SCI

Spinal Cord Injuries Clinical Trial

Official title:

Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940598
• Other study ID #: 000526083
• Secondary ID: R21NR019309
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

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Related Conditions & MeSH terms

• Cardiometabolic Diseases
• Spinal Cord Injuries

Intervention

Other:
• high intensity interval exercise
HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
• No-exercise control group
No-exercise control group

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

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