Circuit Training Program for Persons With Spinal Cord Injury

NCT04263272 | Unknown

• 1 other identifier: 113642
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Keywords

Endocrine-Metabolic health; Cardio-Metabolic health

Outcome Measures

Primary Outcomes (35)

• 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)

• Injury Characteristics Survey

  Date of injury (DD/MM/YYYY)

  Baseline

• Injury Characteristics Survey

  Diagnosis - Traumatic SCI or Non-Traumatic SCI

  Baseline

• Injury Characteristics Survey

  Classification of SCI using the AIS (ASIA Impairment Scale) - A, B, C, D or E

  Baseline

• Injury Characteristics Survey

  Neurological Level or Injury (NLI)

  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.

  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.

  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)

  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)

  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.

  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.

  Baseline and 16 weeks

• Demographics and Lifestyle Questionnaires

  Age in years

  Baseline

• Demographics and Lifestyle Questionnaires

  Gender (Women, Man or Other)

  Baseline

• Demographics and Lifestyle Questionnaires

  Marital Status

  Baseline

• Demographics and Lifestyle Questionnaires

  Ethnicity

  Baseline

• Demographics and Lifestyle Questionnaires

  Highest Education Level completed

  Baseline

• Demographics and Lifestyle Questionnaires

  Currently Employment situation

  Baseline

• Demographics and Lifestyle Questionnaires

  Family income ($ in last year)

  Baseline

• Demographics and Lifestyle Questionnaires

  List of Medical/health problems

  Baseline

• Demographics and Lifestyle Questionnaires

  Smoking levels (yes/no and how many years)

  Baseline

• Demographics and Lifestyle Questionnaires

  Cannabis Use (yes/no, frequency, types of products)

  Baseline

• Demographics and Lifestyle Questionnaires

  Vaping (Yes/no, frequency)

  Baseline

• Demographics and Lifestyle Questionnaires

  Alcohol consumption (frequency and beverages consumed when drinking)

  Baseline

• Demographics and Lifestyle Questionnaires

  Physical Activity levels (minutes/week)

  Baseline

• Change in Medications

  List of medication and supplements currently being taken.

  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.

  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'.

  Baseline and 16 weeks

• Change in Well Being measured by the General Wellbeing Index

  Assessment of emotional wellbeing, on a scale of 0-5.

  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)

  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.

  Baseline and 16 weeks

• Blood Test

  Measurement of metabolic profile (ex: glucose, insulin, triglyceride)

  Baseline and 16 weeks

• Blood Test

  Measurement of bone markers (ex: osteocalcin)

  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)

  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)

  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)

  Baseline and 16 weeks

Study Arms (1)

Upper Body Exercise

EXPERIMENTAL

Seated upper body circuit training program for 16-weeks. Frequency - 1 to 3 one-hour sessions per week.

Other: Upper Body Circuit Training Program

Interventions

Upper Body Circuit Training Program OTHER

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.

Upper Body Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• years or older.

You may not qualify if:

• Power wheelchair users (Non manual wheelchairs)
• Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dalton Wolfe, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalton Wolfe, PhD

CONTACT

5196854292; dwolfe@uwo.ca

Stephanie Marrocco, MSc

CONTACT

5196854292; stephanie.marrocco@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: February 10, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02