Pilot randomised controlled trial of a novel form of exercise on parkinsonism symptoms

Objective Exercise-assistance strategies are useful in allowing mobility-impaired patients to access the benefits of exercise. This trial is the first of the Reviver device, which facilitates exercise via a novel strength and balance training mechanism. The objective was to examine the effect of a 12-week Reviver intervention on symptoms of Parkinsonism, and to pilot the randomised controlled trial design, including randomisation and acceptance of the exercise intervention. Methods This was a pilot, parallel-arm randomised controlled trial with assessor blinding. Participants (n=30: 22 with Parkinson’s disease (PD) and 8 with atypical Parkinsonism conditions (AP)) were allocated to either experimental or control group. The experimental group received 24 sessions of 30 min on the Reviver over 12 weeks, the control group received their standard care. The Movement Disorders Society Unified Parkinson’s Disease Rating Scale, and secondary outcomes (balance, gait, mobility, lower-body strength/coordination, tremor and grip strength) were acquired at endpoints the week prior to intervention commencement and the week after intervention termination. Recruitment progress, adherence to intervention, acceptability of intervention and adverse effects were also recorded. Results For the PD cohort, lower-body strength/coordination (5× Sit-To-Stand; b(95% CI)=−3.02 (−5.16 to –0.89), p=0.013), gait (self-selected walking speed; b=12.48 (2.18 to 22.78), p=0.029, stride length; b=9.75 (0.99 to 18.52), p=0.043) and backward walking speed (b=14.25 (1.93 to 26.57), p=0.038) were improved by the intervention. No significant effect of intervention on the outcome variables was found in the AP cohort. No serious adverse events were recorded. Median adherence to treatment was 95.8%. Interpretation This pilot trial indicates that the Reviver is a safe and well-tolerated exercise-assistance intervention. The Reviver showed some indications of benefit in our secondary measures for PD participants, but not in our primary outcome. This was a small sample, short duration pilot study, and further studies with larger samples and higher exercise volume are warranted to fully assess the safety and efficacy of the device.