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

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Physical Disability
• Intervention / Treatment: Other: Graded Exercise Integrated Education; Other: Conventional Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafifi Hisham; Phone Number: +6011-21215931; Email: hafifi.hisham@rehabmalaysia.com
• Study Contact Backup: Name: Haidzir Manaf; Phone Number: +6012-6615246; Email: haidzir5894@puncakalam.uitm.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graded Exercise Integrated Education; The graded exercise (8 weeks); Strengthening exercise; Aerobic Exercise Educational session to increase exercise self-efficacy and physical activity level (16 weeks)	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)
Active Comparator: Conventional physical therapy; Normal routine of physical therapy (8 weeks)	Other: Conventional Physical Therapy; Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; Physical Fitness; Spinal Cord Injuries; Exercise Self-Efficacy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: Universiti Teknologi MARA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No