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

NCT03420170 | Unknown

• 1 other identifier: Universiti Teknologi MARA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Physical Disability

Keywords

Spinal Cord Injuries; Physical Fitness; Exercise Self-Efficacy; Physical Activity

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Graded Exercise Integrated Education

EXPERIMENTAL

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

Conventional physical therapy

ACTIVE COMPARATOR

Normal routine of physical therapy (8 weeks)

Other: Conventional Physical Therapy

Interventions

Graded Exercise Integrated Education OTHER

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)

Graded Exercise Integrated Education

Conventional Physical Therapy OTHER

Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise

Conventional physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic and Non-traumatic paraplegia
• Wheelchair dependent
• Age range between 18 and 65 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Related Publications (1)

• 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.

  PMID: 30866621 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Central Study Contacts

Hafifi Hisham

CONTACT

+6011-21215931; hafifi.hisham@rehabmalaysia.com

Haidzir Manaf

CONTACT

+6012-6615246; haidzir5894@puncakalam.uitm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share