A randomized controlled feasibility study to evaluate the effects of a goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people at risk of falls (SMART-MOVE): a study protocol.

BACKGROUND

Sedentary behaviour and falls are important interrelated health issues in older people. One in three people aged 65 years and above fall at least once a year and sedentary behaviour has been identified as one of the risk factors for falls. Studies have shown that the duration of sedentary time increases with age. These dual problems need to be addressed effectively as the ageing population grows. Accelerometers enable accurate measurement of sedentary time. This study aims to establish the feasibility and effect of an individualized goal-setting health coaching intervention using feedback initially from an accelerometer and then pedometer over a period of 12 weeks (intervention) compared with providing a one-off advice through a brochure (control), on sedentary time in older people with a recent fall or at risk of one.

METHODS

A single-blinded randomized controlled feasibility trial involving 80 community-dwelling people aged 65 years and above will be conducted with 40 randomized to the intervention and another 40 to control. Primary outcomes will be the feasibility of the intervention and change in total sedentary time at 12 and 24 weeks. Secondary outcomes include a change in fear of falling based on the falls efficacy scale, gait speed, self-reported sedentary time, the proportion of fallers and number of falls. Four focus groups (two from each arm) will be conducted at the end of the study to evaluate the feasibility and effectiveness of this intervention. Feasibility findings will be primarily descriptive. Mean group differences will be examined using independent samples test for normally distributed data and nonparametric tests (Kruskal-Wallis and Mann-Whitney ) for non-normally distributed data. Differences in frequency of variables will be compared using chi-square test. Analysis of variance (ANOVA) will be used to test the post-intervention difference between the two groups at 12 and 24 weeks.

DISCUSSION

The trial will address a key gap in evidence about sedentary behaviour and falls amongst older people and will evaluate the feasibility of an intervention that could be implemented within the primary health care settings.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry 12617001186347, Registered 11 August 2017.