Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

Paraplegia, Spinal Clinical Trial

— HIIT  

Official title:

Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378218
• Other study ID #: 18-004972
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: July 16, 2021

Study information

• Verified date: August 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study seeks to determine whether high intensity interval training has an effect on cardiovascular parameters in wheelchair users with paraplegia.

Description:

The objective of this pilot study is to produce preliminary data testing the feasibility and effectiveness of high intensity interval training (HIIT) on cardiovascular health parameters in individuals with paraplegia. The long term research goal is to determine whether these short term physiologic effects translate to long term reduction in cardiovascular disease and mortality in this high risk population. The rationale for this study is that identifying a well-accepted form of exercise in individuals with paraplegia, which is safe and effective in improving cardiovascular health parameters, would provide an efficient and sustainable evidence-based approach to lowering cardiovascular disease risk. We propose the following two Specific Aims: Specific Aim #1: Measure cardiovascular changes after a 16-week HIIT program in individuals with paraplegia. Measurements will include oxygen utilization during maximal exercise via VO2max testing (primary outcome measure), body composition via dual energy X-ray absorptiometry, blood lipid panel, C-reactive protein blood test, and glucose utilization via oral glucose tolerance blood test. Specific Aim #2: Investigate the feasibility, sustainability and acceptance of implementing high-intensity interval training (HIIT) via arm-ergometer as a form of home exercise in individuals with paraplegia. After the personalized training session with the arm-ergometer and the HIIT protocol, each participant will be given an arm-ergometer (also known as arm-cycle) to use within their home to complete three sessions weekly for the entire16 week program. An adjustable table will be provided to allow for height customization of each arm-ergometer, and provide a method for securing the device during exercise. The arm-ergometers allow the subject to complete the exercise intervention from their own wheelchair. Compliance will be monitored via chest strap heart rate monitors. Acceptance of the program will be determined through a pre- and post- training survey Spinal Cord Injury Exercise Self-Efficacy Scale (SCI ESES) and interview with participants. At the completion of this project, we expect to have determined whether HIIT is an appropriate form of exercise intervention for individuals with paraplegia, effective in improving short-term cardiovascular health parameters within a 16 week home program. We anticipate participants will find HIIT acceptable given the time-efficiency of the protocol, the convenience of using their own wheelchair and the elimination of environmental barriers by performing the program within their home. This study is expected to have a positive impact on cardiovascular health in individuals with paraplegia and foresee this form of exercise being implemented as a standard of care recommendation in the physical activity guidelines for individuals with paraplegia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spinal cord injury located at or below the seventh thoracic vertebrae
• Manual wheelchair user (primary means of mobility)At least 6 months post-SCI
• At least 18 years of age
• Able to perform a high-intensity exercise program
• Willingness to participate in 16 weeks of an exercise program
• Personal cell phone with the ability to run the Polar Beat application and BlueTooth capabilities

Exclusion Criteria:

• Spinal cord injury at or above the sixth thoracic vertebrae
• Manual wheelchair is not the primary means of mobility (ex. community ambulators, power wheelchair users)
• Any documented or reported health condition that would be contraindicated to a progressive exercise program (active upper limb musculoskeletal injuries, autonomic instability, unstable cardiopulmonary disease such as unstable angina, COPD, etc., or pregnancy).
• Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Related Conditions & MeSH terms

• Paraplegia
• Paraplegia, Spinal
• Spinal Cord Injuries
• Spinal Cord Trauma

Intervention

Behavioral:
• High Intensity Interval Training (HIIT)
A 16 week, 3 sessions per week HIIT program from the subject's personal wheelchair, positioned near an adjustable table with an arm-ergometer affixed.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Change in physical activity, as measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) survey	Baseline, Week 8, Week 16
Primary	Exercise self-efficacy	Change in exercise self-efficacy, as measured by the SCI Exercise Self-Efficacy Scale (SCI ESES), with changes in individual responses rated as more true indicating more efficacy.	Baseline, Week 8, Week 16
Primary	Glucose metabolism	Changes in metabolism of glucose, as measured by a 120 minute oral glucose tolerance test (OGTT), with lower glucose values indicating more efficient metabolism.	Baseline, Week 8, Week 16
Primary	Inflammatory marker	Changes in measurements of proteins representing inflammatory processes via the C-Reactive Protein blood test, with lower values indicating a state of less cardiovascular risk.	Baseline, Week 8, Week 16
Primary	Lipid profile	Changes in measurements of total cholesterol, triglycerides, HDL, calculated LDL, and non-HDL cholesterol, with lower values (excepting HDL) indicating lower cardiovascular risk.	Baseline, Week 8, Week 16
Primary	Oxygen metabolism	Changes in metabolism of oxygen, as measured by the Graded Exercise Test (GXT), also known as the VO2 Maximum Test, with higher O2 intake values indicating higher aerobic capacity.	Baseline, Week 8, Week 16
Primary	Bone mineral density	Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.	Baseline, Week 8, Week 16
Primary	Body composition - body fat mass	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.	Baseline, Week 8, Week 16
Primary	Body composition - lean mass	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.	Baseline, Week 8, Week 16
Primary	Body composition - android and gynoid fat percentage	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.	Baseline, Week 8, Week 16
Primary	Body composition - android and gynoid fat ratio	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.	Baseline, Week 8, Week 16
Primary	Body composition - bone mass	Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.	Baseline, Week 8, Week 16

External Links

•   Mayo Clinic Clinical Trials