Intensive exercise program after spinal cord injury (“Full-On”): study protocol for a randomized controlled trial
1 Department of Medicine (Royal Melbourne Hospital), The University of Melbourne, Parkville, VIC 3010, Australia
2 School of Animal Biology (M317), The University of Western Australia, Crawley, WA 6009, Australia
3 Discipline of Exercise and Sports Science, The University of Sydney, Lidcombe, NSW 1825, Australia
4 Victorian Spinal Cord Service, Austin Health, Heidelberg, VIC 3084, Australia
5 Queensland Spinal Cord Injuries Service, Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia
6 Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3010, Australia
7 Florey Institute of Neurosciences and Mental Health, Melbourne Brain Centre (Austin Campus), Heidelberg, VIC 3084, Australia
Trials 2013, 14:291 doi:10.1186/1745-6215-14-291Published: 11 September 2013
Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise.
A multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011.
The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury.