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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graded Exercise Integrated Education | Experimental | The graded exercise (8 weeks)
Educational session to increase exercise self-efficacy and physical activity level (16 weeks) |
|
| Conventional physical therapy | Active Comparator | Normal routine of physical therapy (8 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graded Exercise Integrated Education | Other | Aerobic exercise Wheelchair propelling, boxing, hand cycling (2 rounds)
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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular fitness | 6-Minute Wheelchair Push Test (6-MWPT) | Change from baseline of cardiovascular endurance at 4 months |
| Muscle strength | The upper limb strength measure by using BIODEX ® Isokinetic machine | 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 | 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 | Change from baseline of upper limbs endurance at 4 months |
| Grip strength | The JAMAR ® hand held dynamometer | Change from baseline of grip strength at 4 months |
| Exercise self-efficacy | The Spinal Cord Injury Exercise Self-Efficacy (ESES) | Change from baseline of exercise self-efficacy at 4 months |
| Physical activity level | The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) | Change from baseline of physical activity level at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hafifi Hisham | Contact | +6011-21215931 | hafifi.hisham@rehabmalaysia.com | |
| Haidzir Manaf | Contact | +6012-6615246 | haidzir5894@puncakalam.uitm.edu.my |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30866621 | Derived | Hisham H, Justine M, Hussain H, Hasnan N, Manaf H. Effects of Graded Exercises Integrated with Education on Physical Fitness, Exercise SelfEfficacy, and Activity Levels in People with Spinal Cord Injury: A Quasi-Experimental Study Protocol. Asian Spine J. 2019 Mar 15;13(4):577-583. doi: 10.31616/asj.2018.0172. Print 2019 Aug. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Conventional Physical Therapy | Other | Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise |
|
| D014947 | Wounds and Injuries |
| D001519 | Behavior |