The Cued Up! Study. A randomised controlled trial and feasibility study of a cueing exercise programme for the prevention of falls in persons with Parkinsons disease and freezing of gait

Objective The primary objectives of this study were to evaluate the Cued Up! programme, a six month, standardised, but individually prescribed, home based, progressive cueing exercise programme developed to address freezing of gait (FOG) and reduce falls in Parkinson’s disease (PD), and to determine the feasibility of the programme for future use in a randomised controlled trial (RCT). Secondary objectives of the research were to evaluate the utility and patient acceptability of the programme. Background Falls are common in PD and FOG increases this risk. Cueing training improves gait parameters associated with FOG and may reduce falls in persons with PD. Improvements with cueing are short-lived and wear off when treatment stops. Other studies suggest cueing programmes should be prolonged to sustain improvement. Methods A parallel group, with randomised delayed treatment, design compared falls between an immediate start group (IS) and a delayed start group (DS). Each group received a period of falls monitoring before treatment, followed by the six month Cued Up! exercise programme. The baseline rate of falls was determined by weekly falls diaries one month from study entry. Falls diary recording continued for the one year study duration for all subjects and baseline fall rates were compared for mid and end of active intervention periods. Subjective severity of FOG was measured with the New Freezing of Gait Questionnaire (NFOGQ) before and after intervention. Compliance with and participant rated value and utility of the exercise programme were evaluated by a satisfaction survey at treatment end. Results Consistent with previous research, the Cued Up! study confirms that people with PD and FOG fall frequently with mean (SD) baseline weekly fall rate for all participants of 3.45 (6.5). The range in individual mean baseline fall rates was wide (0 to 40) even with an outlier removed. The estimate of falls rate comparison between IS and DS, calculated using a negative binomial model, was 1.22 (95% CI 0.45 to 3.26, P=0.70). The point estimate is consistent with IS having a higher rate of falls, but the confidence intervals are wide with no evidence of statistical significance. Whilst mean fall rates for all participants appeared to decline during the intervention period, this was not statistically significant. NFOGQ scores were high for participants in general and this is consistent with the participants’ moderate to high disease severity rating and long disease duration. There was no difference in the point estimate of the NFOGQ between the randomised groups (IS and DS), with an estimated difference of -0.95 (95% CI, -7.87 to 5.97), P=0.78. Change from baseline differences in NFOGQ scores were 0.8 (5.0) in the IS group and 1.9 (5.4) in the DS group. The ratio of the change in mean score to its SD for the IS group was 0.8/5.0 = 0.16; and for the DS group 1.9/5.4 = 1.9/5.4 = 0.35. The Cued Up! satisfaction survey indicated the format and content of the programme was acceptable to participants and of value in managing their FOG. Compliance with the programme was high, with 83% of participants indicating they were still doing the exercises at least two to three times per week at the end of the programme. Participants also reported an overall benefit from the programme (89%), improvements in their walking (78%), a reduction in their perceived rate of falling (73%), and improved self-management of their FOG (61%). Conclusions This study provides support for the evidence based Cued Up! exercise programme as a useful and acceptable therapy for the management FOG in PD. Although this study lacked statistical power to detect important changes that may have been a result of the programme, it does provide some useful insights for future research. A larger randomised control trial comparing the Cued Up! programme with another validated falls prevention programme would contribute to the current findings