Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000498099
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
17/06/2010
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
SCIPA (Spinal Cord Injury and Physical Activity) Full-On: Intensive Exercise Program After Spinal Cord Injury
Scientific title
Intensive Exercise Program After Spinal Cord Injury: Effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement in people at least 6 months post spinal cord injury
Secondary ID [1] 251885 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCIPA Full-On
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 257479 0
Condition category
Condition code
Injuries and Accidents 257631 257631 0 0
Other injuries and accidents
Neurological 257746 257746 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A - Experimental Group - comprehensive exercise program: Body weight supported treadmill training (Therastride System, Food and Drug Administration (FDA) registration number 890.5380) allows spinal cord injured patients to stand suspended in a harness by an overhead pulley on a specially designed treadmill for locomotor training. Functional Electrical Stimulation-assisted cycling (RT-300 cycle ergometer) allows spinal cord injured patients to actively exercise using coordinated electrically evoked/enhanced muscle contractions while remaining seated in their wheelchair (fully compliant with 21 Code of Federal Regulations (CFR) Part 820, United States of America (US) FDA Quality Systems Regulations). Trunk and lower extremity exercises will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality. These may be provided in lying (e.g. supine, prone) and in weight-bearing positions (e.g. kneeling, standing). Task specific practice of functional tasks, involving moving the upper body over and outside the base of support, will also be undertaken. This comprehensive exercise program will be conducted 2-3 hours per day, 3 times per week for 12 weeks. Every session will contain all exercises where possible; the amount of time devoted to each component will vary according to a participant's ability and endurance. The aim is to build up the amount of exercise to three hours per session in total. The exercise program will be supervised by a physiotherapist with assistance from an exercise physiologist and/or physiotherapy assistants. The amount of supervision will vary according to the activity, e.g. one-on-one supervision for the trunk and limb exercises, four-on-one for treadmill training.
Intervention code [1] 256575 0
Treatment: Devices
Intervention code [2] 256577 0
Rehabilitation
Comparator / control treatment
Group B - Control Group - upper body exercise program: Upper body circuit-based exercise program incorporating resistance and cardiovascular training, focusing on health and wellbeing. Participants will use standard gym equipment to complete a circuit of exercises as part of a group of 3-4 participants supervised by a physiotherapist or trained exercise instructor. The program will be conducted 3 times per week for 12 weeks. The amount of time devoted to each exercise will vary according to the participant's ability and endurance. The aim is to build up the amount of exercise to three hours per session in total.
Control group
Active

Outcomes
Primary outcome [1] 258541 0
The primary endpoint is the change in American Spinal Injury Association classification (ASIA) Motor Score at 12 weeks (Post Intervention Assessment) compared to baseline
Timepoint [1] 258541 0
Following 12 weeks of treatment compared to baseline
Secondary outcome [1] 264380 0
Change in ASIA Motor Score at 6 and 12 months compared to baseline
Timepoint [1] 264380 0
6 months and 12 months post randomisation compared to baseline
Secondary outcome [2] 264381 0
Change in SCIPA Aerobic Fitness Test at 12 weeks, 6 months and 12 months compared to baseline
Timepoint [2] 264381 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [3] 264382 0
Changes in Spinal Cord Independence Measure (SCIM) and measure of trunk function post intervention (12 weeks), 6 months and 12 months compared to baseline
Timepoint [3] 264382 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [4] 264383 0
Changes in anthropometry measured using Body Mass Index (BMI), skinfolds and abdominal, chest and leg circumferences post intervention, 6 months and 12 months compared to baseline
Timepoint [4] 264383 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [5] 264384 0
Changes in Quality of Life Measures post intervention (Assessment of Quality of Life, Health Utilities Index Mark III and World Health Organisation Quality of Life Questionnaire, brief version (WHOQoL-bref)), 6 months and 12 months compared to baseline
Timepoint [5] 264384 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [6] 264507 0
Changes in spasticity (measured using the the Penn Spasm Frequency Scale) post intervention, 6 months and 12 months compared to baseline
Timepoint [6] 264507 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [7] 264508 0
Changes in pain (measured using the Spinal Cord Injury version of the Multidimensional Pain inventory) post intervention, 6 months and 12 months compared to baseline
Timepoint [7] 264508 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [8] 264509 0
Changes in diurnal blood pressure pattern measured using non-invasive ambulatory blood pressure and pulse rate monitoring post intervention, 6 months and 12 months compared to baseline
Timepoint [8] 264509 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline
Secondary outcome [9] 264510 0
Changes in psychological measures (measured using questionnaires: stress - Perceived Stress Scale, depression - Hospital Depression and Anxiety, health locus of control - Multidimensional Health Locus of Control Scale, self efficacy - Moorong Self-Efficacy Scale, self esteem - Rosenberg Self-Esteem Scale) post intervention, 6 months and 12 months compared to baseline
Timepoint [9] 264510 0
12 weeks (Post Intervention), 6 months and 12 months compared to baseline

Eligibility
Key inclusion criteria
Participants will be included if they:
1. Have sustained a traumatic spinal cord injury (SCI) a minimum of 6 months prior to consent and have completed their primary rehabilitation
2. Are 18 years or older and able to give informed consent
3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
4. Are able and willing to attend an exercise program 3 times per week for 12 weeks
5. Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by the medical consultant is required).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be included if they:
1. Have brachial plexus, cauda equina, or peripheral nerve injury
2. Have had recent major trauma or surgery within the last 6 months
3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
4. Are post-menopausal at time of injury (females)
5. Have Body Mass Index (BMI) at injury falling below lower threshold of healthy adult reference range
6. Have endocrinopathy or metabolic disorders of bone, such as Paget’s disease, lytic or renal bone disease and senile osteoporosis
7. have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
8. Have chronic systemic diseases, e.g. Hepatitis C (Hep C), Human Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDs)
9. Have significant impairment or disability, including physical, neurological or psychological impairments
10. Have a history of long bone fracture, or family history of fragility fracture
11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
12. Have extensive fixed contractures in upper or lower limbs
13. Have severe spasticity
14. Have uncontrolled neuropathic pain
15. Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
17. Have any contraindications to Functional Electrical Stimulation (FES) such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
18. Have intracranial metal implants (for Transcranial Magnetic Stimulation (TMS) only)
19. Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the Protocol.
20. Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will participate in pre-screening, then screening and baseline visits prior to randomisation. Eligible participants will be randomised to one of two groups: 1. Group A - Experimental Group - comprehensive exercise program or 2. Group B - Control Group - upper body exercise program. Randomisation will be stratified by site and injury status (complete/incomplete) and co-ordinated by a central randomisation unit. Upon completion of all screening and baseline assessments and suitability checks, a participant eligibility checklist will be completed by the Site Coordinator and signed by the Principal Investigator. This checklist will be sent to the central randomisation unit who will notify the Site Coordinator of treatment assignment. This will not be disclosed to the Blinded Assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2010
Actual
7/02/2011
Date of last participant enrolment
Anticipated
Actual
30/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
188
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 2672 0
New Zealand
State/province [1] 2672 0
Christchurch

Funding & Sponsors
Funding source category [1] 257073 0
Other Collaborative groups
Name [1] 257073 0
Victorian Neurotrauma Intiative
Country [1] 257073 0
Australia
Funding source category [2] 293811 0
Government body
Name [2] 293811 0
Lifetime Care and Support Authority
Country [2] 293811 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Parkville, VIC 3101
Country
Australia
Secondary sponsor category [1] 256329 0
None
Name [1] 256329 0
Address [1] 256329 0
Country [1] 256329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259094 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 259094 0
Ethics committee country [1] 259094 0
Australia
Date submitted for ethics approval [1] 259094 0
31/05/2010
Approval date [1] 259094 0
18/08/2010
Ethics approval number [1] 259094 0
H2010/03976
Ethics committee name [2] 286408 0
Clinical Trials business Unit Royal Perth Hospital
Ethics committee address [2] 286408 0
Ethics committee country [2] 286408 0
Australia
Date submitted for ethics approval [2] 286408 0
06/10/2010
Approval date [2] 286408 0
05/05/2011
Ethics approval number [2] 286408 0
2010/115
Ethics committee name [3] 286409 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [3] 286409 0
Ethics committee country [3] 286409 0
Australia
Date submitted for ethics approval [3] 286409 0
06/10/2010
Approval date [3] 286409 0
06/12/2010
Ethics approval number [3] 286409 0
101014
Ethics committee name [4] 286410 0
Multi-regional Ethics Commitee New Zealand
Ethics committee address [4] 286410 0
Ethics committee country [4] 286410 0
New Zealand
Date submitted for ethics approval [4] 286410 0
27/09/2010
Approval date [4] 286410 0
23/12/2010
Ethics approval number [4] 286410 0
MEC/10/10/101
Ethics committee name [5] 286411 0
Northern Sydney Central Coast Ethics Committee
Ethics committee address [5] 286411 0
Ethics committee country [5] 286411 0
Australia
Date submitted for ethics approval [5] 286411 0
04/11/2010
Approval date [5] 286411 0
14/12/2010
Ethics approval number [5] 286411 0
HREC/10/HAWKE/142

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31235 0
Prof Mary Galea
Address 31235 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Royal Park Campus
34-54 Poplar Road
Parkville, Victoria, 3052
Country 31235 0
Australia
Phone 31235 0
+61 3 8387 2017
Fax 31235 0
Email 31235 0
[email protected]
Contact person for public queries
Name 14482 0
Melanie Hurley
Address 14482 0
Neuroscience Trials Australia (SCIPA / University of Melbourne)
(a business unit within the Florey Institute of Neuroscience and Mental Health)
Melbourne Brain Centre - Austin Campus
245 Burgundy Street
Heidelberg VIC 3084
Country 14482 0
Australia
Phone 14482 0
+61 3 9035 7235
Fax 14482 0
+61 3 9496 2881
Email 14482 0
[email protected]
Contact person for scientific queries
Name 5410 0
Professor Mary Galea
Address 5410 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Royal Park Campus
34-54 Poplar Road
Parkville, Victoria, 3052
Country 5410 0
Australia
Phone 5410 0
+61 3 8387 2017
Fax 5410 0
Email 5410 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIIntensive exercise program after spinal cord injury (“Full-On”): study protocol for a randomized controlled trial2013https://doi.org/10.1186/1745-6215-14-291
EmbaseSCIPA full-on: A randomized controlled trial comparing intensive whole-body exercise and upper body exercise after spinal cord injury.2018https://dx.doi.org/10.1177/1545968318771213
N.B. These documents automatically identified may not have been verified by the study sponsor.