SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
NCT ID: NCT01236976
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2010-12-31
2016-06-30
Brief Summary
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The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
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Detailed Description
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The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group
Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT) using the Therastride Treadmill System, functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower limb exercise. These interventions will be provided at the spinal unit.
Therastride Treadmill System
This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).
FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
Trunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
Control Group
Participants in Group B will receive an upper body strength and fitness program. This program may be provided at the spinal unit, or an appropriately equipped gymnasium as approved by the SCIPA Full-On Project Committee. It will be based on the Burn Rubber Burn (BRB) exercise program already established in Sydney. BRB is a circuit-based exercise program incorporating resistance and cardiovascular training. For this protocol, the circuit will comprise several stations using different pieces of equipment.
Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
Interventions
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Therastride Treadmill System
This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).
FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
Trunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
Eligibility Criteria
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Inclusion Criteria
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 medical consultant required).
Exclusion Criteria
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 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. Hep C, 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 FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
18. Have intracranial metal implants (for 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.
18 Years
ALL
No
Sponsors
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Austin Health
OTHER_GOV
Hampstead Rehabilitation Centre Adelaide
UNKNOWN
Shenton Park Rehabilitation Centre Perth
UNKNOWN
Royal Rehabilitation Centre Sydney
UNKNOWN
Prince of Wales Hospital, Sydney
OTHER_GOV
Burwood Hospital, Christchurch, New Zealand
OTHER
University of Melbourne
OTHER
Responsible Party
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Mary Galea
Professor Mary Galea
Principal Investigators
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Prof Mary Galea
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Prof Glen Davis
Role: PRINCIPAL_INVESTIGATOR
University of Sydney
Prof Sarah Dunlop
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Dr Andrew Nunn
Role: PRINCIPAL_INVESTIGATOR
Austin Health
Dr Tim Geraghty
Role: PRINCIPAL_INVESTIGATOR
Princess Alexandra Hospital Brisbane
Locations
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Spinal Unit, Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Rehabilitation Centre Sydney
Sydney, New South Wales, Australia
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
Northfield, South Australia, Australia
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
Kew, Victoria, Australia
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
Shenton Park, Western Australia, Australia
Burwood Academy
Christchurch, , New Zealand
Countries
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References
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Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291.
Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A, Olenko L; SCIPA Switch-On Trial Collaborators<xref ref-type="fn" rid="fn1-1545968318771213" ptype="f1545968318771213" citart="citart1">*</xref>. SCIPA Full-On: A Randomized Controlled Trial Comparing Intensive Whole-Body Exercise and Upper Body Exercise After Spinal Cord Injury. Neurorehabil Neural Repair. 2018 Jun;32(6-7):557-567. doi: 10.1177/1545968318771213. Epub 2018 May 7.
Other Identifiers
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SCIPA Full-On
Identifier Type: -
Identifier Source: org_study_id
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