Clinical trial NCT03420170: Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)
Official title: The Effects of Graded Exercise Integrated Education on Physical Fitness, Exercise Self-efficacy, and Physical Activity Level in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Physical Disability
Keywords: Spinal Cord Injuries
Physical Fitness
Exercise Self-Efficacy
Physical Activity
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cardiovascular fitness
timeFrame: Change from baseline of cardiovascular endurance at 4 months
measure: Muscle strength
timeFrame: Change from baseline of upper limbs strength at 4 months
measure: Muscle strength normalize with body weight
timeFrame: Change from baseline of upper limbs strength normalize body weight at 4 months
measure: Muscle endurance
timeFrame: Change from baseline of upper limbs endurance at 4 months
measure: Grip strength
timeFrame: Change from baseline of grip strength at 4 months
measure: Exercise self-efficacy
timeFrame: Change from baseline of exercise self-efficacy at 4 months
measure: Physical activity level
timeFrame: Change from baseline of physical activity level at 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.