Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03420170
• Other study ID #: Universiti Teknologi MARA
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2018
• Last updated: February 1, 2018
• Start date: April 2018
• Est. completion date: April 2019

Study information

• Verified date: January 2018
• Source: Universiti Teknologi Mara
• Contact: Hafifi Hisham
• Phone: +6011-21215931
• Email: hafifi.hisham[@]rehabmalaysia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Disability
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Graded Exercise Integrated Education
Aerobic exercise Wheelchair propelling, boxing, hand cycling (2 rounds) 3 mins. exercise and 2 mins. rest 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)
• Conventional Physical Therapy
Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Teknologi Mara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular fitness	6-Minute Wheelchair Push Test (6-MWPT)	Change from baseline of cardiovascular endurance at 4 months
Primary	Muscle strength	The upper limb strength measure by using BIODEX ® Isokinetic machine	Change from baseline of upper limbs strength at 4 months
Primary	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
Primary	Muscle endurance	The upper limb endurance measure by using BIODEX ® Isokinetic machine	Change from baseline of upper limbs endurance at 4 months
Primary	Grip strength	The JAMAR ® hand held dynamometer	Change from baseline of grip strength at 4 months
Primary	Exercise self-efficacy	The Spinal Cord Injury Exercise Self-Efficacy (ESES)	Change from baseline of exercise self-efficacy at 4 months
Primary	Physical activity level	The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)	Change from baseline of physical activity level at 4 months