Clinical trial NCT04378218: Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia
Official title: Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia, Spinal
Spinal Cord Trauma
Keywords: HIIT
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post trial, observational, feasibility study
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity
timeFrame: Baseline, Week 8, Week 16
measure: Exercise self-efficacy
timeFrame: Baseline, Week 8, Week 16
measure: Glucose metabolism
timeFrame: Baseline, Week 8, Week 16
measure: Inflammatory marker
timeFrame: Baseline, Week 8, Week 16
measure: Lipid profile
timeFrame: Baseline, Week 8, Week 16
measure: Oxygen metabolism
timeFrame: Baseline, Week 8, Week 16
measure: Bone mineral density
timeFrame: Baseline, Week 8, Week 16
measure: Body composition - body fat mass
timeFrame: Baseline, Week 8, Week 16
measure: Body composition - lean mass
timeFrame: Baseline, Week 8, Week 16
measure: Body composition - android and gynoid fat percentage
timeFrame: Baseline, Week 8, Week 16
measure: Body composition - android and gynoid fat ratio
timeFrame: Baseline, Week 8, Week 16
measure: Body composition - bone mass
timeFrame: Baseline, Week 8, Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin L. Garlanger, D.O.
role: PRINCIPAL_INVESTIGATOR
References: