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临床试验/NCT03420170
NCT03420170Unknown不适用

The Effects of Graded Exercise Integrated Education on Physical Fitness, Exercise Self-efficacy, and Physical Activity Level in People With Spinal Cord Injury

Universiti Teknologi Mara0 个研究点目标入组 40 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Exercise self-efficacy

研究概览

简要总结

This is a single blind randomized controlled trial study which will conducted on people with paraplegia wheelchair users. The objectives of this study is to investigates the effects of 16 weeks of 'Graded Exercise Integrated Education' over conventional physical therapy on physical fitness, exercise self-efficacy and the level of physical activity. There will be a significant difference between the experimental and control group.

详细描述

A study protocol will be a single blinded randomised controlled trial. 40 subjects with diagnosed of paraplegia (T1 and below) and dependent with wheelchair will be randomly assigned into 2 groups, Graded exercise (n=20) or Conventional Physical Therapy (n=20). In 8 weeks, the graded exercise group will receive strengthening and aerobic exercise for 2 times a week, and the controlled group will continue their normal routine. The strengthening exercise will consist of strength training for major upper limb muscles in the multigym station and free weights dumbbell whereas the aerobic exercise will perform by using arm ergometry, boxing and wheelchair wheeling. The exercise will be graded and progressed for each week in 8 weeks. The graded exercise group also will receive educational intervention to increase the exercise self-efficacy and physical activity level which will conduct in face to face for 2 times a week in 8 weeks during in-rehabilitation program and once on every 4 weeks in 8 weeks after discharge from in-rehabilitation program. The outcomes are the strength and endurance of upper limb which will be measure by using a BIODEX® Isokinetic Machine and hand grip strength by JAMAR® Hand-held dynamometry. The cardiovascular endurance will be measure by using 6 minute wheelchair push test (6MWPT). The exercise self-efficacy and physical activity level will be measure by using 'Exercise Self-Efficacy Scale (ESES)' and 'Physical Activity Scale for Individual with Disability (PASIPD)'. The outcome measure will be evaluated at the baseline level, week 4th, week 8th, week 12th, and 16th. Statistical analysis will be carried out using the SPSS 21.0 program for Windows and a significant level of p ≤ 0.05 will be used for all tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Traumatic and Non-traumatic paraplegia
  • •Wheelchair dependent
  • •Age range between 18 and 65 years old

排除标准

  • •Pregnancy
  • •Individual who suffered from progressive neurological diseases, depression and mental disorder
  • •Individual with frequent autonomic dysreflexia and hypotension
  • •Individual with comorbid recent fracture
  • •Individual with severe heart diseases and pain
  • •Individual who not understand Malay and English
  • •Individual who not understand instructions and obey commands
  • •Individual who difficult to reach via telephone, email or social media

研究组 & 干预措施

Graded Exercise Integrated Education

Experimental

The graded exercise (8 weeks)

  1. Strengthening exercise
  2. Aerobic Exercise

Educational session to increase exercise self-efficacy and physical activity level (16 weeks)

干预措施: Graded Exercise Integrated Education (Other)

Conventional physical therapy

Active Comparator

Normal routine of physical therapy (8 weeks)

干预措施: Conventional Physical Therapy (Other)

结局指标

主要结局

Exercise self-efficacy

时间窗: Change from baseline of exercise self-efficacy at 4 months

The Spinal Cord Injury Exercise Self-Efficacy (ESES)

Cardiovascular fitness

时间窗: Change from baseline of cardiovascular endurance at 4 months

6-Minute Wheelchair Push Test (6-MWPT)

Muscle strength

时间窗: Change from baseline of upper limbs strength at 4 months

The upper limb strength measure by using BIODEX ® Isokinetic machine

Muscle strength normalize with body weight

时间窗: Change from baseline of upper limbs strength normalize body weight at 4 months

The upper limb strength normalize with body weight measure by using BIODEX ® Isokinetic machine

Muscle endurance

时间窗: Change from baseline of upper limbs endurance at 4 months

The upper limb endurance measure by using BIODEX ® Isokinetic machine

Grip strength

时间窗: Change from baseline of grip strength at 4 months

The JAMAR ® hand held dynamometer

Physical activity level

时间窗: Change from baseline of physical activity level at 4 months

The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noor Hafifi Noor Hisham

Principal Investigator

Universiti Teknologi Mara

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