Intensive exercise program after spinal cord injury (“Full-On”): study protocol for a randomized controlled trial

Trials

Leonid Churilov⁶  Ya-seng (Arthur) Hsueh⁴  Timothy Geraghty³  Andrew Nunn⁵  Glen M Davis⁷  Sarah A Dunlop¹  Mary P Galea² 

[1] School of Animal Biology (M317), The University of Western Australia, Crawley, WA 6009, Australia;Department of Medicine (Royal Melbourne Hospital), The University of Melbourne, Parkville, VIC 3010, Australia;Queensland Spinal Cord Injuries Service, Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia;Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3010, Australia;Victorian Spinal Cord Service, Austin Health, Heidelberg, VIC 3084, Australia;Florey Institute of Neurosciences and Mental Health, Melbourne Brain Centre (Austin Campus), Heidelberg, VIC 3084, Australia;Discipline of Exercise and Sports Science, The University of Sydney, Lidcombe, NSW 1825, Australia

关键词: FES;    Locomotor training;    Exercise;    Randomized controlled trial;    Spinal cord injury;   

Others  :  1093079
DOI  :  10.1186/1745-6215-14-291

 received in 2013-07-13, accepted in 2013-08-27,  发布年份 2013

【 摘 要 】

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

NCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).

【 授权许可】

   
2013 Galea et al.; licensee BioMed Central Ltd.

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