SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury

NCT01236976 | Completed Phase 3 DMC

• 1 other identifier: SCIPA Full-On
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 6

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: Therastride Treadmill System; Device: FES-assisted cycling; Other: Trunk and upper and lower limb exercises

Control Group

OTHER

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.

Other: Upper body strength and fitness program

Interventions

Therastride Treadmill System DEVICE

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).

Intervention Group

FES-assisted cycling DEVICE

This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).

Intervention Group

Trunk and upper and lower limb exercises OTHER

This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.

Intervention Group

Upper body strength and fitness program OTHER

This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation
• Are 18 years or older and able to give informed consent
• Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
• Are able and willing to attend an exercise program 3 times per week for 12 weeks
• Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).

You may not qualify if:

• Have brachial plexus, cauda equina, or peripheral nerve injury
• Have had recent major trauma or surgery within the last 6 months
• Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
• Are post-menopausal at time of injury (females)
• Have BMI at injury falling below lower threshold of healthy adult reference range
• Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis
• have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
• Have chronic systemic diseases, e.g. Hep C, HIV-AIDs
• Have significant impairment or disability, including physical, neurological or psychological impairments
• Have a history of long bone fracture, or family history of fragility fracture
• Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
• Have extensive fixed contractures in upper or lower limbs
• Have severe spasticity
• Have uncontrolled neuropathic pain
• Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture

Sponsors & Collaborators

• University of Melbourne: lead
• Austin Health: collaborator
• Hampstead Rehabilitation Centre Adelaide: collaborator
• Shenton Park Rehabilitation Centre Perth: collaborator
• Royal Rehabilitation Centre Sydney: collaborator
• Prince of Wales Hospital, Sydney: collaborator
• Burwood Hospital, Christchurch, New Zealand: collaborator

Study Sites (6)

Spinal Unit, Prince of Wales Hospital

Randwick, New South Wales, Australia

Location

Royal Rehabilitation Centre Sydney

Sydney, New South Wales, Australia

Location

South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre

Northfield, South Australia, Australia

Location

Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre

Kew, Victoria, 3101, Australia

Location

Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital

Shenton Park, Western Australia, Australia

Location

Burwood Academy

Christchurch, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 24025260 BACKGROUND

• 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.

  PMID: 35545824 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Prof Mary Galea

  University of Melbourne

  PRINCIPAL INVESTIGATOR

• Prof Glen Davis

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Prof Sarah Dunlop

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

• Dr Andrew Nunn

  Austin Health

  PRINCIPAL INVESTIGATOR

• Dr Tim Geraghty

  Princess Alexandra Hospital Brisbane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Mary Galea

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2016
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (1)