Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

NCT04378218 | Completed

• 1 other identifier: 18-004972
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paraplegia, Spinal; Spinal Cord Trauma

Keywords

HIIT

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

HIIT Intervention

EXPERIMENTAL

Behavioral: High Intensity Interval Training (HIIT)

Interventions

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.

HIIT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Paraplegia; Spinal Cord Injuries

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristin L. Garlanger, D.O.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-post trial, observational, feasibility study

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: May 7, 2020
• Study Start: December 12, 2019
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)