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
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
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
NCT ID
NCT04263272
First Posted
December 5, 2019
Last Updated
February 7, 2020
Sponsor
Lawson Health Research Institute
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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