Circuit Training Program for Persons With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Circuit Training Program Tom Improve Endocrine-Metabolic Function in Persons With Spinal Cord Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04263272
• Other study ID #: 113642
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Lawson Health Research Institute
• Contact: Dalton Wolfe, PhD
• Phone: 5196854292
• Email: dwolfe[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The program will integrate members of the community who are > 18 months post-injury with those currently participating in SCI rehabilitation as inpatient.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Upper Body Circuit Training Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility survey	Feasibility question options range from -3 to +3 on a likert scale, higher scores indicated a greater level of feasibility.	After Study Completion (16 weeks)
Primary	Injury Characteristics Survey	Date of injury (DD/MM/YYYY)	Baseline
Primary	Injury Characteristics Survey	Diagnosis - Traumatic SCI or Non-Traumatic SCI	Baseline
Primary	Injury Characteristics Survey	Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E	Baseline
Primary	Injury Characteristics Survey	Neurological Level or Injury (NLI)	Baseline
Primary	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.	Baseline and 16 weeks
Primary	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.	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks
Primary	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.	Baseline and 16 weeks
Primary	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.	Baseline and 16 weeks
Primary	Demographics and Lifestyle Questionnaires	Age in years	Baseline
Primary	Demographics and Lifestyle Questionnaires	Gender (Women, Man or Other)	Baseline
Primary	Demographics and Lifestyle Questionnaires	Marital Status	Baseline
Primary	Demographics and Lifestyle Questionnaires	Ethnicity	Baseline
Primary	Demographics and Lifestyle Questionnaires	Highest Education Level completed	Baseline
Primary	Demographics and Lifestyle Questionnaires	Currently Employment situation	Baseline
Primary	Demographics and Lifestyle Questionnaires	Family income ($ in last year)	Baseline
Primary	Demographics and Lifestyle Questionnaires	List of Medical/health problems	Baseline
Primary	Demographics and Lifestyle Questionnaires	Smoking levels (yes/no and how many years)	Baseline
Primary	Demographics and Lifestyle Questionnaires	Cannabis Use (yes/no, frequency, types of products)	Baseline
Primary	Demographics and Lifestyle Questionnaires	Vaping (Yes/no, frequency)	Baseline
Primary	Demographics and Lifestyle Questionnaires	Alcohol consumption (frequency and beverages consumed when drinking)	Baseline
Primary	Demographics and Lifestyle Questionnaires	Physical Activity levels (minutes/week)	Baseline
Primary	Change in Medications	List of medication and supplements currently being taken.	Baseline and 16 weeks
Primary	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.	Baseline and 16 weeks
Primary	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'.	Baseline and 16 weeks
Primary	Change in Well Being measured by the General Wellbeing Index	Assessment of emotional wellbeing, on a scale of 0-5.	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks
Primary	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.	Baseline and 16 weeks
Primary	Blood Test	Measurement of metabolic profile (ex: glucose, insulin, triglyceride)	Baseline and 16 weeks
Primary	Blood Test	Measurement of bone markers (ex: osteocalcin)	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks
Primary	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)	Baseline and 16 weeks