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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
Universiti Teknologi Mara
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 19, 2018
    Last Updated
    February 1, 2018
    Sponsor
    Universiti Teknologi Mara
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    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

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

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