Early exercise after spinal cord injury (‘Switch-On’): study protocol for a randomised controlled trial

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist: schedule of enrolment, interventions, and assessments

	Enrolment	Allocation	Intervention	Post-intervention
TIMEPOINT	-t ₁	0	12 weeks	12 weeks
ENROLMENT:
Eligibility screen	X
Informed consent	X
Medical clearance	X
Allocation		X
INTERVENTIONS:
*FES-assisted cycling*
*Passive cycling*
*ASSESSMENTS:**
*Muscle cross-sectional area of thigh and calf (1° outcome measure)*	X			X
*Serum sclerostin*	X			X
*Other serum biomarkers*	X			X
*Muscle mass*	X			X
*ISNCSCI Motor and Sensory Scores*	X			X
*Depression (HADS)*	X			X
*Quality of Life*	X			X
*(HUI3, AQoL, WHOQoL-Bref)*

*1-week window allowed for assessments.
FES = functional electrical stimulation; ISNCSCI = International Standard for Neurological Classification of Spinal Cord Injury; HADS = Hospital Anxiety and Depression Scale; HUI3 = Health Utilities Index Mark 3; AQoL = Assessment of Quality of Life; WHOQoL-Bref = WHO Quality of Life-Bref.

ISSN: 1745-6215