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Circuit Training Program for Persons With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper Body Circuit Training Program
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Endocrine-Metabolic health, Cardio-Metabolic health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Community:

  • Chronic traumatic or non-traumatic SCI between level C6 and T10 >18 months post injury
  • manual wheelchair as the primary mode of mobility
  • no existing conditions that would make it unsafe to participate in an exercise program (e.g., fractures).
  • Ability to understand and communicate in English.
  • 18 years or older.

Inpatients:

  • Chronic traumatic or non-traumatic SCI between level C6 and T10
  • manual wheelchair as primary mode of mobility
  • no existing conditions that would make it unsafe to participate in an exercise program (e.g., fractures).
  • Ability to understand and communicate in English.
  • 18 years or older.

Exclusion Criteria:

  • Power wheelchair users (Non manual wheelchairs)
  • Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Upper Body Exercise

    Arm Description

    Seated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week.

    Outcomes

    Primary Outcome Measures

    Feasibility survey
    Feasibility question options range from -3 to +3 on a likert scale, higher scores indicated a greater level of feasibility.
    Injury Characteristics Survey
    Date of injury (DD/MM/YYYY)
    Injury Characteristics Survey
    Diagnosis - Traumatic SCI or Non-Traumatic SCI
    Injury Characteristics Survey
    Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E
    Injury Characteristics Survey
    Neurological Level or Injury (NLI)
    Change in Spinal Cord Injury Independence Measure - Mobility
    Assessment of degree to which participant can independently preform mobility tasks, such as transfers, and the ue of mobility aids.
    Change in Upper and Lower Extremity Strength by a manual muscle test (MMT)
    Assessment of joint (Shoulder, elbow, wrist, hip, knee and ankle) muscle strength using a Manual muscle test.
    Change in Upper and Lower Extremity Range of Motion
    Assessment of joint range of motion in the upper and lower extremities (Shoulder, elbow, wrist, hip, knee and ankle)
    Change in Spasticity in upper and lower extremities using the Modified Ashworth Scale
    Assessment of muscle tone through range of motion, on a scale of 0-4 (0= no increase in muscle tone; 4 = rigidity in flexion or extension)
    Change in Maximal Safe Wheel chair speed measured using the Propulsion Speed Test
    20 meter straight line wheel chair speed test. 3 trails were be preformed at a comfortable speed and 3 trials will be preformed at a maximal but safe speed.
    Change in Ability to safety navigate wheel chair using the Slalmon Speed test
    Objective is to weave between a set of cones without touching them as fast as safely possible. 3 attempts will be given.
    Demographics and Lifestyle Questionnaires
    Age in years
    Demographics and Lifestyle Questionnaires
    Gender (Women, Man or Other)
    Demographics and Lifestyle Questionnaires
    Marital Status
    Demographics and Lifestyle Questionnaires
    Ethnicity
    Demographics and Lifestyle Questionnaires
    Highest Education Level completed
    Demographics and Lifestyle Questionnaires
    Currently Employment situation
    Demographics and Lifestyle Questionnaires
    Family income ($ in last year)
    Demographics and Lifestyle Questionnaires
    List of Medical/health problems
    Demographics and Lifestyle Questionnaires
    Smoking levels (yes/no and how many years)
    Demographics and Lifestyle Questionnaires
    Cannabis Use (yes/no, frequency, types of products)
    Demographics and Lifestyle Questionnaires
    Vaping (Yes/no, frequency)
    Demographics and Lifestyle Questionnaires
    Alcohol consumption (frequency and beverages consumed when drinking)
    Demographics and Lifestyle Questionnaires
    Physical Activity levels (minutes/week)
    Change in Medications
    List of medication and supplements currently being taken.
    Change in Experienced Pain
    The international Spinal Cord Injury Pain Data Set will be used to evaluate the presence and severity of pain. Description of 3 main pain concerns and there intensity. Intensity ranges from 0 = no pain to 10 = worst possible pain.
    Change in Wheel Chair skills ability using the Wheel Chair skills Test Questionnaire
    Questionnaire assesses the ability and confidence in preforming numerous wheel chair skills (ex: turning the wheelchair around a small space) Questions answers include 'No' 'partially' 'yes' 'very well'.
    Change in Well Being measured by the General Wellbeing Index
    Assessment of emotional wellbeing, on a scale of 0-5.
    Change in Quality of life and health measured by the WHOQOL-BREF
    Self reported questionnaire assessing quality of life (physical, social, environment and psychological health) on a scale of 1 - 4 (1=poor/not al all; 5= very good/extreme amount)
    Change in aerobic capacity (VO2max) measured by 6-min wheelchair propulsion test
    Objective is to get the largest total distance. Pylons are placed 25meters apart, participants starts in the middle go around the first cone to the let return to the middle and make a full stop, then continue to the right of second cone, go around it and back to the middle, making a figure 8. Continue that pattern for 6 minutes.
    Blood Test
    Measurement of metabolic profile (ex: glucose, insulin, triglyceride)
    Blood Test
    Measurement of bone markers (ex: osteocalcin)
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Measurement of bone mineral density of the full body (reported using a T score)
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Measurement of bone mineral density of the femoral head (reported using a T score)
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Measurement of bone mineral density of the lumbar spine (reported using a T score)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2019
    Last Updated
    February 7, 2020
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04263272
    Brief Title
    Circuit Training Program for Persons With Spinal Cord Injury
    Official Title
    Circuit Training Program Tom Improve Endocrine-Metabolic Function in Persons With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute

    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
    This initiative represents development and pilot testing of a circuit training exercise program for persons with spinal cord injury (SCI) to be implemented within a rehabilitation centre. The program will integrate members of the community who are > 18 months post-injury with those currently participating in SCI rehabilitation as inpatient.
    Detailed Description
    This initiative represents development and pilot testing of a 16 week circuit training exercise program for persons with spinal cord injury (SCI) to be implemented within a rehabilitation centre (Parkwood Institute, London, ON). The primary purpose of this trial is one of feasibility - i.e., testing out several aspects of the trial for the purposes of determining what features of the exercise intervention and the various outcome measurements might be a part of subsequent trials. In addition, a subset of this data will serve as preliminary comparison information for Dr. Dany Gagnon's study at the University of Montreal. In this way, this is not a true multi-centre trial in that we are not conducting an identical protocol to a study he is conducting. Rather, we are using some of the same outcome measures and an exercise intervention that has some similar parameters to one that he is implementing in Montreal - with a view to providing a preliminary comparison of outcomes of a subset of participants in our study so as to inform the development of future studies. For this reason, the group of community-dwelling persons with SCI will have more cardio-metabolic outcome measurements taken, as they represent the primary group of interest to Dr. Gagnon. Overall, the program will integrate members of the community who are > 18 months post-injury (n=8) with those currently participating in SCI rehabilitation as inpatients (n=8). Outcomes will be collected to test the effects of the program on an array of cardio-metabolic measures in those participants with chronic SCI, as well as the feasibility of the program for all participants (N=16). Note: although a participant can decline to continue participation at any time, it is likely that many inpatient participants will choose to not continue participation if this proves logistically difficult (if they move back to their home community away from London).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries
    Keywords
    Endocrine-Metabolic health, Cardio-Metabolic health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Upper Body Exercise
    Arm Type
    Experimental
    Arm Description
    Seated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week.
    Intervention Type
    Other
    Intervention Name(s)
    Upper Body Circuit Training Program
    Intervention Description
    16 week seated upper body exercise for persons with Spinal Cord Injuries. Participants will attend 2-3 exercise sessions a week, sessions have a mix of SCI community members and inpatients.
    Primary Outcome Measure Information:
    Title
    Feasibility survey
    Description
    Feasibility question options range from -3 to +3 on a likert scale, higher scores indicated a greater level of feasibility.
    Time Frame
    After Study Completion (16 weeks)
    Title
    Injury Characteristics Survey
    Description
    Date of injury (DD/MM/YYYY)
    Time Frame
    Baseline
    Title
    Injury Characteristics Survey
    Description
    Diagnosis - Traumatic SCI or Non-Traumatic SCI
    Time Frame
    Baseline
    Title
    Injury Characteristics Survey
    Description
    Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E
    Time Frame
    Baseline
    Title
    Injury Characteristics Survey
    Description
    Neurological Level or Injury (NLI)
    Time Frame
    Baseline
    Title
    Change in Spinal Cord Injury Independence Measure - Mobility
    Description
    Assessment of degree to which participant can independently preform mobility tasks, such as transfers, and the ue of mobility aids.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Upper and Lower Extremity Strength by a manual muscle test (MMT)
    Description
    Assessment of joint (Shoulder, elbow, wrist, hip, knee and ankle) muscle strength using a Manual muscle test.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Upper and Lower Extremity Range of Motion
    Description
    Assessment of joint range of motion in the upper and lower extremities (Shoulder, elbow, wrist, hip, knee and ankle)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Spasticity in upper and lower extremities using the Modified Ashworth Scale
    Description
    Assessment of muscle tone through range of motion, on a scale of 0-4 (0= no increase in muscle tone; 4 = rigidity in flexion or extension)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Maximal Safe Wheel chair speed measured using the Propulsion Speed Test
    Description
    20 meter straight line wheel chair speed test. 3 trails were be preformed at a comfortable speed and 3 trials will be preformed at a maximal but safe speed.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Ability to safety navigate wheel chair using the Slalmon Speed test
    Description
    Objective is to weave between a set of cones without touching them as fast as safely possible. 3 attempts will be given.
    Time Frame
    Baseline and 16 weeks
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Age in years
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Gender (Women, Man or Other)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Marital Status
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Ethnicity
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Highest Education Level completed
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Currently Employment situation
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Family income ($ in last year)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    List of Medical/health problems
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Smoking levels (yes/no and how many years)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Cannabis Use (yes/no, frequency, types of products)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Vaping (Yes/no, frequency)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Alcohol consumption (frequency and beverages consumed when drinking)
    Time Frame
    Baseline
    Title
    Demographics and Lifestyle Questionnaires
    Description
    Physical Activity levels (minutes/week)
    Time Frame
    Baseline
    Title
    Change in Medications
    Description
    List of medication and supplements currently being taken.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Experienced Pain
    Description
    The international Spinal Cord Injury Pain Data Set will be used to evaluate the presence and severity of pain. Description of 3 main pain concerns and there intensity. Intensity ranges from 0 = no pain to 10 = worst possible pain.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Wheel Chair skills ability using the Wheel Chair skills Test Questionnaire
    Description
    Questionnaire assesses the ability and confidence in preforming numerous wheel chair skills (ex: turning the wheelchair around a small space) Questions answers include 'No' 'partially' 'yes' 'very well'.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Well Being measured by the General Wellbeing Index
    Description
    Assessment of emotional wellbeing, on a scale of 0-5.
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Quality of life and health measured by the WHOQOL-BREF
    Description
    Self reported questionnaire assessing quality of life (physical, social, environment and psychological health) on a scale of 1 - 4 (1=poor/not al all; 5= very good/extreme amount)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in aerobic capacity (VO2max) measured by 6-min wheelchair propulsion test
    Description
    Objective is to get the largest total distance. Pylons are placed 25meters apart, participants starts in the middle go around the first cone to the let return to the middle and make a full stop, then continue to the right of second cone, go around it and back to the middle, making a figure 8. Continue that pattern for 6 minutes.
    Time Frame
    Baseline and 16 weeks
    Title
    Blood Test
    Description
    Measurement of metabolic profile (ex: glucose, insulin, triglyceride)
    Time Frame
    Baseline and 16 weeks
    Title
    Blood Test
    Description
    Measurement of bone markers (ex: osteocalcin)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Description
    Measurement of bone mineral density of the full body (reported using a T score)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Description
    Measurement of bone mineral density of the femoral head (reported using a T score)
    Time Frame
    Baseline and 16 weeks
    Title
    Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
    Description
    Measurement of bone mineral density of the lumbar spine (reported using a T score)
    Time Frame
    Baseline and 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Community: Chronic traumatic or non-traumatic SCI between level C6 and T10 >18 months post injury manual wheelchair as the primary mode of mobility no existing conditions that would make it unsafe to participate in an exercise program (e.g., fractures). Ability to understand and communicate in English. 18 years or older. Inpatients: Chronic traumatic or non-traumatic SCI between level C6 and T10 manual wheelchair as primary mode of mobility no existing conditions that would make it unsafe to participate in an exercise program (e.g., fractures). Ability to understand and communicate in English. 18 years or older. Exclusion Criteria: Power wheelchair users (Non manual wheelchairs) Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalton Wolfe, PhD
    Phone
    5196854292
    Ext
    42957
    Email
    dwolfe@uwo.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Marrocco, MSc
    Phone
    5196854292
    Ext
    42631
    Email
    stephanie.marrocco@sjhc.london.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dalton Wolfe, PhD
    Organizational Affiliation
    Lawson Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Circuit Training Program for Persons With Spinal Cord Injury

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