Clinical trial NCT01236976: SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
Official title: SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injury
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Austin Health
name: Hampstead Rehabilitation Centre Adelaide
name: Shenton Park Rehabilitation Centre Perth
name: Royal Rehabilitation Centre Sydney
name: Prince of Wales Hospital, Sydney
name: Burwood Hospital, Christchurch, New Zealand
First posted: 2010-11-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.

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.

Detailed description: The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group articipants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.

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.

Eligibility criteria: Inclusion Criteria:

1. Have sustained a traumatic spinal cord injury 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 medical consultant required).

Exclusion Criteria:

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 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.

Primary outcomes:
measure: To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Spinal Unit, Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Rehabilitation Centre Sydney
state: New South Wales
city: Northfield
country: Australia
facility: South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
state: South Australia
city: Kew
country: Australia
facility: Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
state: Victoria
city: Shenton Park
country: Australia
facility: Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
state: Western Australia
city: Christchurch
country: New Zealand
facility: Burwood Academy
Study officials:
affiliation: University of Melbourne
name: Prof Mary Galea
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Prof Glen Davis
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Prof Sarah Dunlop
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Health
name: Dr Andrew Nunn
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Alexandra Hospital Brisbane
name: Dr Tim Geraghty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.