Circuit Training Program for Persons With Spinal Cord Injury

Not Applicable

• Conditions: Spinal Cord Injuries
• Interventions: Other: Upper Body Circuit Training Program

• Registration Number: NCT04263272
• Lead Sponsor: Lawson Health Research Institute

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).

Study Timeline

• Study First Submitted: 2019-12-05
• Status Verified: 2020-02
• Study Start: 2020-02
• Study First Submitted QC: 2020-02-07
• Last Update Submitted: 2020-02-07
• Study First Posted: 2020-02-10
• Last Update Posted: 2020-02-10
• Primary Completion: 2020-05
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper Body Exercise	Upper Body Circuit Training Program	Seated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week.

Primary Outcome Measures

Name	Time	Method
Change in Spinal Cord Injury Independence Measure - Mobility	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)	Baseline and 16 weeks	Assessment of joint (Shoulder, elbow, wrist, hip, knee and ankle) muscle strength using a Manual muscle test.
Change in Spasticity in upper and lower extremities using the Modified Ashworth Scale	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 Ability to safety navigate wheel chair using the Slalmon Speed test	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.
Feasibility survey	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.
Change in Wheel Chair skills ability using the Wheel Chair skills Test Questionnaire	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 Quality of life and health measured by the WHOQOL-BREF	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)
Injury Characteristics Survey	Baseline	Neurological Level or Injury (NLI)
Change in Upper and Lower Extremity Range of Motion	Baseline and 16 weeks	Assessment of joint range of motion in the upper and lower extremities (Shoulder, elbow, wrist, hip, knee and ankle)
Demographics and Lifestyle Questionnaires	Baseline	Physical Activity levels (minutes/week)
Change in Experienced Pain	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 Well Being measured by the General Wellbeing Index	Baseline and 16 weeks	Assessment of emotional wellbeing, on a scale of 0-5.
Change in Medications	Baseline and 16 weeks	List of medication and supplements currently being taken.
Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)	Baseline and 16 weeks	Measurement of bone mineral density of the lumbar spine (reported using a T score)
Change in Maximal Safe Wheel chair speed measured using the Propulsion Speed Test	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 aerobic capacity (VO2max) measured by 6-min wheelchair propulsion test	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	Baseline and 16 weeks	Measurement of bone markers (ex: osteocalcin)