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

NCT ID: NCT03420170

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Spinal Cord Injuries; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Graded Exercise Integrated Education

Intervention Type: 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)

Conventional physical therapy

Normal routine of physical therapy (8 weeks)

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Conventional Physical Therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Teknologi Mara

OTHER

Sponsor Role: lead

Responsible Party

Noor Hafifi Noor Hisham

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hafifi Hisham

Role: CONTACT

hafifi.hisham@rehabmalaysia.com

+6011-21215931

Haidzir Manaf

Role: CONTACT

haidzir5894@puncakalam.uitm.edu.my

+6012-6615246

References

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.

Reference Type: DERIVED

PMID: 30866621 (View on PubMed)

Other Identifiers

Universiti Teknologi MARA

Identifier Type: -

Identifier Source: org_study_id