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

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ClinicalTrials.gov Identifier: NCT03420170
Recruitment Status : Not yet recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Noor Hafifi Noor Hisham, Universiti Teknologi Mara

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Physical Disability Other: Graded Exercise Integrated Education Other: Conventional Physical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Graded Exercise Integrated Education

The graded exercise (8 weeks)

  1. Strengthening exercise
  2. 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)

  1. 3 mins. exercise and 2 mins. rest
  2. 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




Primary Outcome Measures :
  1. Cardiovascular fitness [ Time Frame: Change from baseline of cardiovascular endurance at 4 months ]
    6-Minute Wheelchair Push Test (6-MWPT)

  2. Muscle strength [ Time Frame: Change from baseline of upper limbs strength at 4 months ]
    The upper limb strength measure by using BIODEX ® Isokinetic machine

  3. Muscle strength normalize with body weight [ Time Frame: Change from baseline of upper limbs strength normalize body weight at 4 months ]
    The upper limb strength normalize with body weight measure by using BIODEX ® Isokinetic machine

  4. Muscle endurance [ Time Frame: Change from baseline of upper limbs endurance at 4 months ]
    The upper limb endurance measure by using BIODEX ® Isokinetic machine

  5. Grip strength [ Time Frame: Change from baseline of grip strength at 4 months ]
    The JAMAR ® hand held dynamometer

  6. Exercise self-efficacy [ Time Frame: Change from baseline of exercise self-efficacy at 4 months ]
    The Spinal Cord Injury Exercise Self-Efficacy (ESES)

  7. Physical activity level [ Time Frame: Change from baseline of physical activity level at 4 months ]
    The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420170


Contacts
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Contact: Hafifi Hisham +6011-21215931 hafifi.hisham@rehabmalaysia.com
Contact: Haidzir Manaf +6012-6615246 haidzir5894@puncakalam.uitm.edu.my

Sponsors and Collaborators
Universiti Teknologi Mara

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Noor Hafifi Noor Hisham, Principal Investigator, Universiti Teknologi Mara
ClinicalTrials.gov Identifier: NCT03420170     History of Changes
Other Study ID Numbers: Universiti Teknologi MARA
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noor Hafifi Noor Hisham, Universiti Teknologi Mara:
Spinal Cord Injuries
Physical Fitness
Exercise Self-Efficacy
Physical Activity

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System