The Home-based Older People's Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty.

BACKGROUND frailty is a state of vulnerability to stressor events. There is uncertainty about the beneficial effects of exercise interventions for older people with frailty. The Home-based Older People's Exercise (HOPE) programme is a 12-week-exercise intervention for older people with frailty designed to improve mobility and function. METHODS we tested feasibility of the HOPE programme in a two arm, assessor blind pilot randomised controlled trial (RCT). Eligibility criteria included living at home and receiving case manager care, being housebound or attending day centres in Bradford, UK. Intervention participants received the HOPE programme; control participants received usual care. Objectives were to gather process, resource, management and scientific data to inform the design of a definitive trial. Primary outcome was mobility, measured using the timed-up-and-go test (TUGT). Secondary outcomes were activities of daily living, health-related quality of life and depression. Participants were stratified by the baseline TUGT score. Randomisation was by the University of Leeds Clinical Trials Research Unit. RESULTS eighty-four participants were recruited. Forty-five were randomised to intervention and 39 to control. Forty intervention participants and 30 control participants were included in the intention-to-treat analysis. There was a non-significant trend towards a clinically important improved outcome in the intervention group (mean adjusted between-group difference in the TUGT 28.6 s, 95% CI -8.5, 65.9 s). There were no differences in secondary outcomes. CONCLUSION the HOPE trial has provided preliminary evidence that the deterioration in mobility experienced by older people with frailty may be reduced through a 12-week-exercise intervention. The pilot trial has provided the necessary data to design a future definitive RCT.Trial registration and date of first participant randomisation.Current Controlled Trials: International Standard Randomised Controlled Trial Number ISRCTN57066881. Date of trial registration 19/05/2010. Date of first participant randomisation 15/07/2010.