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Trial record 3 of 9 for:    spinal cord injury AND cycling | Open Studies

HIIT in Spinal Cord Injury (HIIT-SCI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by Alicia Koontz, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Alicia Koontz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03152110
First received: May 9, 2017
Last updated: May 11, 2017
Last verified: May 2017
  Purpose

Objectives: Spinal cord injury (SCI) is debilitating to an individual's health and functional capacity and can significantly reduce quality of life. Specifically, SCI contributes to a sedentary lifestyle and a subsequent elevated risk for preventable cardiometabolic and hypokinetic diseases. While physical activity is strongly promoted in persons with SCI as a means to reduce the incidence and development of secondary disabling conditions, a majority of individuals with SCI are inactive and have low levels of fitness. High intensity interval training (HIIT) is a form of exercise that is characterized by brief, intermittent bouts of intense exercise, separated by periods of lower intensity exercise for recovery. The magnitude of improvements in aerobic exercise capacity and other key cardiometabolic risk factors following HIIT are similar to moderate-intensity continuous training, but only require a fraction of the total energy expenditure and a vastly reduced time commitment. Little research has been conducted on HIIT in persons with SCI, who are unique from other special population groups due to their inability to carry out conventional lower limb HIIT exercises. An upper extremity form of HIIT that is effective, safe, quick and has acceptable positive affect could be an attractive option for persons with SCI who are not presently exercising and have low fitness levels. The study will look at feasibility and acceptability of a 6-week HIIT program for persons with a spinal cord injury who are untrained.

Methods: Investigators aim to test 10 individuals with spinal cord injury/dysfunction who are untrained and use a manual wheelchair full time for mobility. Prior to starting any testing or exercising, participants will be screened and will need to obtain a signed medical release form from their physician. The screening procedure will include asking the participant the inclusion/exclusion criteria and administering two short questionnaires related to physical activity that will determine eligibility for the study. After obtaining the release form, participants will be scheduled for their first visit. During Visit 1, participants will complete baseline exercise testing and questionnaires. The study questionnaires will include questionnaires related to sociodemographics, pain and health measures, general health and function, 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 the six week time period, participants will be scheduled for Visit 2 and will complete the same evaluations as Visit 1. Additionally, participants will complete evaluations measuring the level of satisfaction of the training program and their likelihood of continuing the program.


Condition Intervention
Spinal Cord Injuries
Spinal Cord Diseases
Other: HIIT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Feasibility and Acceptability of Six-weeks of High Intensity Interval Training in Wheelchair Users With SCI

Resource links provided by NLM:


Further study details as provided by Alicia Koontz, University of Pittsburgh:

Primary Outcome Measures:
  • HIIT Times [ Time Frame: To be recorded weekly, throughout study completion (3x/week for 6 weeks) ]
    Work/rest times (minutes)

  • Power [ Time Frame: To be completed at baseline, at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]
    Peak/average power (watts)

  • Cardiopulmonary Measures [ Time Frame: To be completed at baseline and at 6 weeks post-study completion ]
    VO2, CO2, VE, VE/CO2 and VE/VCO2 (all measured in L/min)

  • Cardiopulmonary Measures [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]
    Heart rate (bpm)

  • Enjoyment of HIIT [ Time Frame: To be completed at 6 weeks post-study completion ]
    Physical Activity Enjoyment Scale (PACES)

  • Acceptability of HIIT [ Time Frame: To be completed at 6 weeks post-study completion ]
    Exercise Evaluation Form

  • Feasibility of HIIT [ Time Frame: To be recorded throughout study completion (6 weeks) ]
    Total days of exercise completed


Secondary Outcome Measures:
  • Physical Activity Status [ Time Frame: To be completed at baseline ]
    The physical activity scale for individuals with physical disabilities (PASIPD)

  • Perceived Exertion [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]
    Borg Scale (6-20)

  • Perceived Exertion (Adapted) [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]
    Wheel Scale (1-10)

  • Feelings During HIIT [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion; throughout each training session (3x/week for 6 weeks) ]
    Feeling Scale (-6 to +6)

  • Wrist, Elbow, Shoulder Pain [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]
    Numerical Rating Scale

  • Shoulder Pain [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]
    Wheelchair Users Shoulder Pain Index

  • General Health & Function [ Time Frame: To be recorded at baseline, and at 6 weeks post-study completion ]
    SF-36 WW


Estimated Enrollment: 10
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIIT
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

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of fractures or dislocations in the upper extremity from which the participant has not fully recovered
  2. Upper limb pain or injury that interferes with the ability to perform aerobic exercise
  3. No current or recent (last 6 months) participation in a structured fitness program
  4. Recent hospitalization for any reason (within the past three months)
  5. Pregnant women
  6. History of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
  7. Likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to vigorous exercise
  8. Any other conditions that the persons primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or vigorous exercise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03152110

Contacts
Contact: Khara James 412-822-3700 kharajames@pitt.edu
Contact: Stacy Eckstein 412-822-3700 seckstein@pitt.edu

Sponsors and Collaborators
University of Pittsburgh
  More Information

Responsible Party: Alicia Koontz, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03152110     History of Changes
Other Study ID Numbers: PRO17020277
Study First Received: May 9, 2017
Last Updated: May 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alicia Koontz, University of Pittsburgh:
High Intensity Interval Training
HIIT
Physical Activity

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 25, 2017