Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)
Primary Purpose
Spinal Cord Injuries, Physical Disability
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Graded Exercise Integrated Education
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Physical Fitness, Exercise Self-Efficacy, Physical Activity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Graded Exercise Integrated Education
Conventional physical therapy
Arm Description
The graded exercise (8 weeks) Strengthening exercise Aerobic Exercise Educational session to increase exercise self-efficacy and physical activity level (16 weeks)
Normal routine of physical therapy (8 weeks)
Outcomes
Primary Outcome Measures
Cardiovascular fitness
6-Minute Wheelchair Push Test (6-MWPT)
Muscle strength
The upper limb strength measure by using BIODEX ® Isokinetic machine
Muscle strength normalize with body weight
The upper limb strength normalize with body weight measure by using BIODEX ® Isokinetic machine
Muscle endurance
The upper limb endurance measure by using BIODEX ® Isokinetic machine
Grip strength
The JAMAR ® hand held dynamometer
Exercise self-efficacy
The Spinal Cord Injury Exercise Self-Efficacy (ESES)
Physical activity level
The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Secondary Outcome Measures
Full Information
NCT ID
NCT03420170
First Posted
January 19, 2018
Last Updated
February 1, 2018
Sponsor
Universiti Teknologi Mara
1. Study Identification
Unique Protocol Identification Number
NCT03420170
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Physical Disability
Keywords
Spinal Cord Injuries, Physical Fitness, Exercise Self-Efficacy, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graded Exercise Integrated Education
Arm Type
Experimental
Arm Description
The graded exercise (8 weeks)
Strengthening exercise
Aerobic Exercise
Educational session to increase exercise self-efficacy and physical activity level (16 weeks)
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Normal routine of physical therapy (8 weeks)
Intervention Type
Other
Intervention Name(s)
Graded Exercise Integrated Education
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise
Primary Outcome Measure Information:
Title
Cardiovascular fitness
Description
6-Minute Wheelchair Push Test (6-MWPT)
Time Frame
Change from baseline of cardiovascular endurance at 4 months
Title
Muscle strength
Description
The upper limb strength measure by using BIODEX ® Isokinetic machine
Time Frame
Change from baseline of upper limbs strength at 4 months
Title
Muscle strength normalize with body weight
Description
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
Title
Muscle endurance
Description
The upper limb endurance measure by using BIODEX ® Isokinetic machine
Time Frame
Change from baseline of upper limbs endurance at 4 months
Title
Grip strength
Description
The JAMAR ® hand held dynamometer
Time Frame
Change from baseline of grip strength at 4 months
Title
Exercise self-efficacy
Description
The Spinal Cord Injury Exercise Self-Efficacy (ESES)
Time Frame
Change from baseline of exercise self-efficacy at 4 months
Title
Physical activity level
Description
The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time Frame
Change from baseline of physical activity level at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafifi Hisham
Phone
+6011-21215931
Email
hafifi.hisham@rehabmalaysia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haidzir Manaf
Phone
+6012-6615246
Email
haidzir5894@puncakalam.uitm.edu.my
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30866621
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.
Results Reference
derived
Learn more about this trial
Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)
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