An interventional study of Graded Exercise Integrated Education and Conventional Physical Therapy in Spinal Cord Injuries and Physical Disability, sponsored by Universiti Teknologi Mara. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Universiti Teknologi Mara · Not applicable, Interventional, and Treatment
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.
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Universiti Teknologi Mara is the lead sponsor of 26 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The graded exercise (8 weeks) 1. Strengthening exercise 2. Aerobic Exercise Educational session to increase exercise self-efficacy and physical activity level (16 weeks)
Other: Graded Exercise Integrated Education
Normal routine of physical therapy (8 weeks)
Other: Conventional Physical Therapy
Aerobic exercise Wheelchair propelling, boxing, hand cycling (2 rounds) 1. 3 mins. exercise and 2 mins. rest 2. Increased to 4.5 mins. and 30 sec. rest Strengthening exercise: Vertical chest press, butterfly press; vertical row and wide lattissimus pull down 3 sets, 10 reps. and 2 min rest between sets, moderate to vigorous intensity (50% of 1 RM) Educational intervention: The educational intervention for exercise self-efficacy and physical activity level (2 hours a week for 8 weeks during in rehabilitation and once a month for 8 weeks after discharge from rehabilitation)
Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise
Cardiovascular fitness
6-Minute Wheelchair Push Test (6-MWPT)
Time frame: Change from baseline of cardiovascular endurance at 4 months
Muscle strength
The upper limb strength measure by using BIODEX ® Isokinetic machine
Time frame: Change from baseline of upper limbs strength at 4 months
Muscle strength normalize with body weight
The upper limb strength normalize with body weight measure by using BIODEX ® Isokinetic machine
Time frame: Change from baseline of upper limbs strength normalize body weight at 4 months
Muscle endurance
The upper limb endurance measure by using BIODEX ® Isokinetic machine
Time frame: Change from baseline of upper limbs endurance at 4 months
Grip strength
The JAMAR ® hand held dynamometer
Time frame: Change from baseline of grip strength at 4 months
Exercise self-efficacy
The Spinal Cord Injury Exercise Self-Efficacy (ESES)
Time frame: Change from baseline of exercise self-efficacy at 4 months
Physical activity level
The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time frame: Change from baseline of physical activity level at 4 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Apr 2018; primary completion for Apr 2019, 12 months later.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 12 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Universiti Teknologi Mara