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Completed

NCT Number: NCT04378218

Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

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

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Key information

Conditions

Paraplegia, Spinal Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Trauma Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training (HIIT)

Behavioral

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.

Primary outcomes

  1. Physical activity

    Time frame: Baseline, Week 8, Week 16

    Change in physical activity, as measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) survey

  2. Exercise self-efficacy

    Time frame: Baseline, Week 8, Week 16

    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.

  3. Glucose metabolism

    Time frame: Baseline, Week 8, Week 16

    Changes in metabolism of glucose, as measured by a 120 minute oral glucose tolerance test (OGTT), with lower glucose values indicating more efficient metabolism.

  4. Inflammatory marker

    Time frame: Baseline, Week 8, Week 16

    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.

  5. Lipid profile

    Time frame: Baseline, Week 8, Week 16

    Changes in measurements of total cholesterol, triglycerides, HDL, calculated LDL, and non-HDL cholesterol, with lower values (excepting HDL) indicating lower cardiovascular risk.

  6. Oxygen metabolism

    Time frame: Baseline, Week 8, Week 16

    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.

  7. Bone mineral density

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.

  8. Body composition - body fat mass

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.

  9. Body composition - lean mass

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.

  10. Body composition - android and gynoid fat percentage

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.

  11. Body composition - android and gynoid fat ratio

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.

  12. Body composition - bone mass

    Time frame: Baseline, Week 8, Week 16

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: HIIT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 7, 2020
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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