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Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia (HIIT)

Primary Purpose

Paraplegia, Spinal, Spinal Cord Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training (HIIT)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Paraplegia, Spinal focused on measuring HIIT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT Intervention

Arm Description

Outcomes

Primary Outcome Measures

Physical activity
Change in physical activity, as measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) survey
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.
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.
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.
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.
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.
Bone mineral density
Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.
Body composition - body fat mass
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.
Body composition - lean mass
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.
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.
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.
Body composition - bone mass
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
August 19, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04378218
Brief Title
Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia
Acronym
HIIT
Official Title
Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia, Spinal, Spinal Cord Trauma
Keywords
HIIT

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post trial, observational, feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training (HIIT)
Intervention Description
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 Outcome Measure Information:
Title
Physical activity
Description
Change in physical activity, as measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) survey
Time Frame
Baseline, Week 8, Week 16
Title
Exercise self-efficacy
Description
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.
Time Frame
Baseline, Week 8, Week 16
Title
Glucose metabolism
Description
Changes in metabolism of glucose, as measured by a 120 minute oral glucose tolerance test (OGTT), with lower glucose values indicating more efficient metabolism.
Time Frame
Baseline, Week 8, Week 16
Title
Inflammatory marker
Description
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.
Time Frame
Baseline, Week 8, Week 16
Title
Lipid profile
Description
Changes in measurements of total cholesterol, triglycerides, HDL, calculated LDL, and non-HDL cholesterol, with lower values (excepting HDL) indicating lower cardiovascular risk.
Time Frame
Baseline, Week 8, Week 16
Title
Oxygen metabolism
Description
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.
Time Frame
Baseline, Week 8, Week 16
Title
Bone mineral density
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.
Time Frame
Baseline, Week 8, Week 16
Title
Body composition - body fat mass
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.
Time Frame
Baseline, Week 8, Week 16
Title
Body composition - lean mass
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.
Time Frame
Baseline, Week 8, Week 16
Title
Body composition - android and gynoid fat percentage
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.
Time Frame
Baseline, Week 8, Week 16
Title
Body composition - android and gynoid fat ratio
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.
Time Frame
Baseline, Week 8, Week 16
Title
Body composition - bone mass
Description
Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.
Time Frame
Baseline, Week 8, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin L. Garlanger, D.O.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

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