Clinical trial NCT04263272: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Endocrine-Metabolic health
Cardio-Metabolic health
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: Feasibility survey
timeFrame: After Study Completion (16 weeks)
measure: Injury Characteristics Survey
timeFrame: Baseline
measure: Injury Characteristics Survey
timeFrame: Baseline
measure: Injury Characteristics Survey
timeFrame: Baseline
measure: Injury Characteristics Survey
timeFrame: Baseline
measure: Change in Spinal Cord Injury Independence Measure - Mobility
timeFrame: Baseline and 16 weeks
measure: Change in Upper and Lower Extremity Strength by a manual muscle test (MMT)
timeFrame: Baseline and 16 weeks
measure: Change in Upper and Lower Extremity Range of Motion
timeFrame: Baseline and 16 weeks
measure: Change in Spasticity in upper and lower extremities using the Modified Ashworth Scale
timeFrame: Baseline and 16 weeks
measure: Change in Maximal Safe Wheel chair speed measured using the Propulsion Speed Test
timeFrame: Baseline and 16 weeks
measure: Change in Ability to safety navigate wheel chair using the Slalmon Speed test
timeFrame: Baseline and 16 weeks
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Demographics and Lifestyle Questionnaires
timeFrame: Baseline
measure: Change in Medications
timeFrame: Baseline and 16 weeks
measure: Change in Experienced Pain
timeFrame: Baseline and 16 weeks
measure: Change in Wheel Chair skills ability using the Wheel Chair skills Test Questionnaire
timeFrame: Baseline and 16 weeks
measure: Change in Well Being measured by the General Wellbeing Index
timeFrame: Baseline and 16 weeks
measure: Change in Quality of life and health measured by the WHOQOL-BREF
timeFrame: Baseline and 16 weeks
measure: Change in aerobic capacity (VO2max) measured by 6-min wheelchair propulsion test
timeFrame: Baseline and 16 weeks
measure: Blood Test
timeFrame: Baseline and 16 weeks
measure: Blood Test
timeFrame: Baseline and 16 weeks
measure: Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
timeFrame: Baseline and 16 weeks
measure: Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
timeFrame: Baseline and 16 weeks
measure: Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
timeFrame: Baseline and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Dalton Wolfe, PhD
role: PRINCIPAL_INVESTIGATOR
References: