Spinal Cord InjuriesNCT04263272
Circuit Training Program for Persons With Spinal Cord Injury
A study testing Upper Body Circuit Training Program in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Upper Body Circuit Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Power wheelchair users (Non manual wheelchairs)
- Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Circuit Training Program Tom Improve Endocrine-Metabolic Function in Persons With Spinal Cord Injury
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.
Read the 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).
- Conditions
- Spinal Cord Injuries
- Being tested
- Upper Body Circuit Training Program
- Keywords
- Endocrine-Metabolic health, Cardio-Metabolic health
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Body Circuit Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Body Exercise | Experimental | Seated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week. Receives: Other: Upper Body Circuit Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility survey
Feasibility question options range from -3 to +3 on a likert scale, higher scores indicated a greater level of feasibility.
Measured: After Study Completion (16 weeks)
Injury Characteristics Survey
Date of injury (DD/MM/YYYY)
Measured: Baseline
Injury Characteristics Survey
Diagnosis - Traumatic SCI or Non-Traumatic SCI
Measured: Baseline
Injury Characteristics Survey
Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E
Measured: Baseline
Injury Characteristics Survey
Neurological Level or Injury (NLI)
Measured: Baseline
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.
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 weeks
Demographics and Lifestyle Questionnaires
Age in years
Measured: Baseline
Demographics and Lifestyle Questionnaires
Gender (Women, Man or Other)
Measured: Baseline
Demographics and Lifestyle Questionnaires
Marital Status
Measured: Baseline
Demographics and Lifestyle Questionnaires
Ethnicity
Measured: Baseline
Demographics and Lifestyle Questionnaires
Highest Education Level completed
Measured: Baseline
Demographics and Lifestyle Questionnaires
Currently Employment situation
Measured: Baseline
Demographics and Lifestyle Questionnaires
Family income ($ in last year)
Measured: Baseline
Demographics and Lifestyle Questionnaires
List of Medical/health problems
Measured: Baseline
Demographics and Lifestyle Questionnaires
Smoking levels (yes/no and how many years)
Measured: Baseline
Demographics and Lifestyle Questionnaires
Cannabis Use (yes/no, frequency, types of products)
Measured: Baseline
Demographics and Lifestyle Questionnaires
Vaping (Yes/no, frequency)
Measured: Baseline
Demographics and Lifestyle Questionnaires
Alcohol consumption (frequency and beverages consumed when drinking)
Measured: Baseline
Demographics and Lifestyle Questionnaires
Physical Activity levels (minutes/week)
Measured: Baseline
Change in Medications
List of medication and supplements currently being taken.
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 weeks
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'.
Measured: Baseline and 16 weeks
Change in Well Being measured by the General Wellbeing Index
Assessment of emotional wellbeing, on a scale of 0-5.
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
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.
Measured: Baseline and 16 weeks
Blood Test
Measurement of metabolic profile (ex: glucose, insulin, triglyceride)
Measured: Baseline and 16 weeks
Blood Test
Measurement of bone markers (ex: osteocalcin)
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
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)
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalton Wolfe, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Dalton Wolfe, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263272
- Sponsor's protocol ID
- 113642
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit Training Program Tom Improve Endocrine-Metabolic Function in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04263272
- Acronym / sponsor ID
- 113642
- Conditions
- Spinal Cord Injuries
- Keywords
- Endocrine-Metabolic health, Cardio-Metabolic health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper Body Exercise | Experimental | Other: Upper Body Circuit Training ProgramSeated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- Power wheelchair users (Non manual wheelchairs)
- Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Body Circuit Training Program16 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. | Other | Upper Body Exercise |
Primary outcome
Feasibility survey
Time frame: After Study Completion (16 weeks)
Feasibility question options range from -3 to +3 on a likert scale, higher scores indicated a greater level of feasibility.
Injury Characteristics Survey
Time frame: Baseline
Date of injury (DD/MM/YYYY)
Injury Characteristics Survey
Time frame: Baseline
Diagnosis - Traumatic SCI or Non-Traumatic SCI
Injury Characteristics Survey
Time frame: Baseline
Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E
Injury Characteristics Survey
Time frame: Baseline
Neurological Level or Injury (NLI)
Change in Spinal Cord Injury Independence Measure - Mobility
Time frame: Baseline and 16 weeks
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)
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline
Age in years
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Gender (Women, Man or Other)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Marital Status
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Ethnicity
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Highest Education Level completed
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Currently Employment situation
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Family income ($ in last year)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
List of Medical/health problems
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Smoking levels (yes/no and how many years)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Cannabis Use (yes/no, frequency, types of products)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Vaping (Yes/no, frequency)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Alcohol consumption (frequency and beverages consumed when drinking)
Demographics and Lifestyle Questionnaires
Time frame: Baseline
Physical Activity levels (minutes/week)
Change in Medications
Time frame: Baseline and 16 weeks
List of medication and supplements currently being taken.
Change in Experienced Pain
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
Assessment of emotional wellbeing, on a scale of 0-5.
Change in Quality of life and health measured by the WHOQOL-BREF
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
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
Time frame: Baseline and 16 weeks
Measurement of metabolic profile (ex: glucose, insulin, triglyceride)
Blood Test
Time frame: Baseline and 16 weeks
Measurement of bone markers (ex: osteocalcin)
Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
Time frame: Baseline and 16 weeks
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)
Time frame: Baseline and 16 weeks
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)
Time frame: Baseline and 16 weeks
Measurement of bone mineral density of the lumbar spine (reported using a T score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalton Wolfe, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A study testing Upper Body Circuit Training Program in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalton Wolfe, PhD (5196854292 ext. 42957, dwolfe@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility survey (time frame: After Study Completion (16 weeks)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.