Spinal Cord InjuriesNCT03420170
Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)
A study testing Graded Exercise Integrated Education and Conventional Physical Therapy in people with Spinal Cord Injuries and Physical Disability, run by Universiti Teknologi Mara.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Physical Disability
- What is being tested?
- Graded Exercise Integrated Education and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic and Non-traumatic paraplegia
- Wheelchair dependent
- Age range between 18 and 65 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Graded Exercise Integrated Education, Conventional Physical Therapy
- Keywords
- Spinal Cord Injuries, Physical Fitness, Exercise Self-Efficacy, Physical Activity
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Exercise Integrated EducationOther
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)
Conventional Physical TherapyOther
Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Graded Exercise Integrated Education |
| Conventional physical therapy | Active comparator | Normal routine of physical therapy (8 weeks) Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular fitness
6-Minute Wheelchair Push Test (6-MWPT)
Measured: Change from baseline of cardiovascular endurance at 4 months
Muscle strength
The upper limb strength measure by using BIODEX ® Isokinetic machine
Measured: 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
Measured: 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
Measured: Change from baseline of upper limbs endurance at 4 months
Grip strength
The JAMAR ® hand held dynamometer
Measured: Change from baseline of grip strength at 4 months
Exercise self-efficacy
The Spinal Cord Injury Exercise Self-Efficacy (ESES)
Measured: Change from baseline of exercise self-efficacy at 4 months
Physical activity level
The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Measured: Change from baseline of physical activity level at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Hafifi Noor Hisham, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420170
- Sponsor's protocol ID
- Universiti Teknologi MARA
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30866621
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03420170
- Acronym / sponsor ID
- Universiti Teknologi MARA
- Conditions
- Spinal Cord Injuries, Physical Disability
- Keywords
- Spinal Cord Injuries, Physical Fitness, Exercise Self-Efficacy, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Exercise Integrated Education | Experimental | Other: Graded Exercise Integrated EducationThe graded exercise (8 weeks) 1. Strengthening exercise 2. Aerobic Exercise Educational session to increase exercise self-efficacy and physical activity level (16 weeks) |
| Conventional physical therapy | Active comparator | Other: Conventional Physical TherapyNormal routine of physical therapy (8 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic and Non-traumatic paraplegia
- Wheelchair dependent
- Age range between 18 and 65 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Exercise Integrated EducationAerobic 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) | Other | Graded Exercise Integrated Education |
| Conventional Physical TherapyNormal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise | Other | Conventional physical therapy |
Primary outcome
Cardiovascular fitness
Time frame: Change from baseline of cardiovascular endurance at 4 months
6-Minute Wheelchair Push Test (6-MWPT)
Muscle strength
Time frame: Change from baseline of upper limbs strength at 4 months
The upper limb strength measure by using BIODEX ® Isokinetic machine
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
Muscle endurance
Time frame: Change from baseline of upper limbs endurance at 4 months
The upper limb endurance measure by using BIODEX ® Isokinetic machine
Grip strength
Time frame: Change from baseline of grip strength at 4 months
The JAMAR ® hand held dynamometer
Exercise self-efficacy
Time frame: Change from baseline of exercise self-efficacy at 4 months
The Spinal Cord Injury Exercise Self-Efficacy (ESES)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 30866621Hisham 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Exercise Integrated Education and Conventional Physical Therapy in people with Spinal Cord Injuries and Physical Disability, run by Universiti Teknologi Mara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hafifi Hisham (+6011-21215931, hafifi.hisham@rehabmalaysia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular fitness (time frame: Change from baseline of cardiovascular endurance at 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.