Circuit Training Program Tom Improve Endocrine-Metabolic Function in Persons With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 主要终点
- Change in Spinal Cord Injury Independence Measure - Mobility
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Power wheelchair users (Non manual wheelchairs)
- •Have an existing condition that would make it unsafe to participate in an exercise program (e.g., fracture)
结局指标
主要结局
Change in Spinal Cord Injury Independence Measure - Mobility
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 Upper and Lower Extremity Range of Motion
时间窗: 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 Experienced Pain
时间窗: 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
时间窗: Baseline and 16 weeks
Assessment of emotional wellbeing, on a scale of 0-5.
Change in Medications
时间窗: Baseline and 16 weeks
List of medication and supplements currently being taken.
Change in Maximal Safe Wheel chair speed measured using the Propulsion Speed Test
时间窗: 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
时间窗: 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.
Injury Characteristics Survey
时间窗: Baseline
Date of injury (DD/MM/YYYY)
Demographics and Lifestyle Questionnaires
时间窗: Baseline
Age in years
Blood Test
时间窗: Baseline and 16 weeks
Measurement of metabolic profile (ex: glucose, insulin, triglyceride)
Change in Body composition measured by DEXA (Dual energy x-ray absorptiometry)
时间窗: Baseline and 16 weeks
Measurement of bone mineral density of the full body (reported using a T score)
次要结局
未报告次要终点
研究者
Dalton Wolfe
Principal Investigator
Lawson Health Research Institute