Feasibility of HIIT in Spinal Cord Injury

NCT03152110 | Completed Results DMC

• 2 other identifiers: PRO170202771P2CHD086851
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) is debilitating to an individual's health, functional capacity and quality of life. This contributes to a sedentary lifestyle and an elevated risk for cardiometabolic and hypokinetic diseases. While physical activity is promoted in persons with SCI to reduce incidence of secondary disabling conditions, a majority of individuals are inactive and have low levels of fitness. High intensity interval training (HIIT) is a form of exercise characterized by brief, intermittent bouts of intense exercise, separated by periods of lower intensity exercise for recovery. The level of improvements in aerobic exercise capacity following HIIT are similar to moderate-intensity continuous training, but only require a fraction of the total energy and time commitment. Little research has been done on HIIT in persons with SCI, who are unable to carry out conventional lower limb HIIT exercises. An upper extremity form of HIIT that is effective, safe, and quick could be an attractive option for these individuals. The study will look at feasibility and acceptability of a 6-week HIIT program for persons with a spinal cord injury who are untrained. Investigators will test 10 untrained individuals with SCI/D who use a manual wheelchair full time. Prior to any testing, participants will be screened and will need to obtain a signed medical release from their physician. The screening involves asking the participant the inclusion/exclusion criteria and administering two short questionnaires related to physical activity. After obtaining the release form, participants will be scheduled for their first visit. During Visit 1, baseline testing and questionnaires will be completed. The study questionnaires will address sociodemographics, pain and health measures, general health, and physical activity. Exercise testing includes an aerobic exercise stress test (conducted following American College of Sports Medicine guidelines using an electronic ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will exercise three times per week for six weeks, following a standard HIIT protocol. Two of those sessions will be supervised by a trainer, and one session will be completed on their own. After six weeks, participants will be scheduled for Visit 2 and will complete the same evaluations as Visit 1. Additionally, participants will complete evaluations on their level of satisfaction of the training program and their likelihood to continue.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

High Intensity Interval Training; HIIT; Physical Activity

Outcome Measures

Primary Outcomes (7)

• HIIT Times

  Number of HIIT Work/Rest Times (number of intervals) completed by the participants per session (averaged over all sessions and participants)

  To be recorded weekly, throughout study completion (3x/week for 6 weeks)

• Power

  Change in peak power output (watts) pre and post HIIT training.

  Baseline and 6 weeks

• Cardiopulmonary Measures

  Change in Peak Oxygen Consumption (VO2) pre and post HIIT training (measured in mL/kg/min)

  Baseline and 6 weeks

• Cardiopulmonary Measures

  Peak heart rates achieved during each work interval within a training session were averaged together and then averaged over all training sessions and expressed as a percentage of the participant's maximum heart rate obtained at baseline, during training, or at the 6 week followup whichever value was highest. The peak training heart rates were then averaged across all participants to provide an overall measure of physical effort exerted by the group during HIIT exercise.

  Recorded during each training session (3x/week for 6 weeks)

• Enjoyment of HIIT

  Measured using the Physical Activity Enjoyment Scale (PACES). The summative score ranges from 18 to 126 with higher scores indicating higher levels of enjoyment

  6 weeks

• Acceptability of HIIT

  Measured using the scores on one question on the Exercise Evaluation Form: "Rate your overall experience with the exercise intervention". Scores ranged from 5 (Very Satisfied) to 1 (Very Dissatisfied).

  6 weeks

• Percentage of Participants Completing All Supervised Training Sessions

  The number of participants who completed all the supervised training sessions (12 sessions over 6 weeks) as a percentage of the total number of participants who completed the 6 week study. The HIIT program was considered feasible if a majority of participants (80% or more) were able to complete all 12 supervised training sessions in the 6 week study time frame.

  To be recorded throughout study completion (6 weeks)

Secondary Outcomes (3)

• Perceived Exertion

  Recorded during each training session (3x/week for 6 weeks)

• Perceived Exertion (Adapted)

  To be recorded during each training session (3x/week for 6 weeks)

• Feelings During HIIT

  Recorded during each training session (3x/week for 6 weeks)

Study Arms (1)

HIIT

EXPERIMENTAL

Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.

Other: HIIT

Interventions

HIIT OTHER

A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed during the previous supervised session. The bike computer automatically stores HR and PPO.

HIIT

Eligibility Criteria

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

You may qualify if:

• SCI/D which occurred at least 6 months prior to the start of the study
• uses a manual wheelchair as primary means of mobility (30+ hours per week)
• is between 18 and 65 years of age
• Weighs less than 250lbs
• lives within one hour driving time from the research center
• is able to perform a transfer independently to and from a wheelchair
• has adequate strength and upper extremity function to operate a handcycle or arm ergometer
• has adequate space in a safe location (i.e., home, work) to accommodate a handcycle or tabletop ergometer
• Receipt of a signed physicians medical release form

You may not qualify if:

• History of fractures or dislocations in the upper extremity from which the participant has not fully recovered
• Upper limb pain or injury that interferes with the ability to perform aerobic exercise
• No current or recent (last 6 months) participation in a structured fitness program
• Recent hospitalization for any reason (within the past three months)
• Pregnant women
• History of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
• Likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to vigorous exercise
• Any other conditions that the persons primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or vigorous exercise

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Alabama at Birmingham: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Results Point of Contact

• Title: Alicia Koontz
• Organization: University of Pittsburgh

akoontz@pitt.edu

412-822-3700

Study Officials

• Alicia Koontz, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: January 2, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)