Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.
BACKGROUND
After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke.


METHODS
This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained.


CONCLUSIONS
Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events.


BACKGROUND
This trial is registered with the Clinical Trials.gov Registry (NCT01679600).
Department of Health Sciences and Technology, Institute of Human Movement Sciences and Sport, ETH Zurich, Wolfgang-Pauli-Strasse 27, 8093, Zurich, Switzerland. eling.debruin@hest.ethz.ch.
Oliver
O
Stoller
Eling D
ED
de Bruin
Corina
C
Schuster-Amft
Matthias
M
Schindelholz
Rob A
RA
de Bie
Kenneth J
KJ
Hunt
D002985:Clinical Protocols; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods*; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005246:Feedback; D006801:Humans; D007297:Inpatients; D009043:Motor Activity; D010865:Pilot Projects; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012371:Robotics; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D013557:Switzerland; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking