Abstract
Background: Previous research has demonstrated effectiveness of a podiatry intervention in reducing falls among community dwelling older people. The purpose of this project was to (i) establish the feasibility of implementing and testing this existing podiatry intervention in the CH setting, (ii) remodel the intervention and subsequent trial in light of the feasibility findings to suit the CH context, and (iii) estimate the effect size of the remodelled intervention on falls in a pilot rando- mised controlled trial (RCT). Here, we report the findings from the pilot RCT.
Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.
Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2
groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 % CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 % CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 % CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 % of participants attempting the exercises 3 times per week.
Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.
Methods: The pre-RCT feasibility work has been reported elsewhere. The re- modelled multifaceted podiatry intervention (MPI) consists of: foot orthoses provision (Formthotics™, Christchurch, New Zealand), foot-wear assessment and provision, ankle dorsiflexion/plantarflexion exercises, and toe flexor exercises. We subsequently conducted a two armed, rater blinded, pilot randomised controlled trial of the MPI with outcome assessment at 3, 6 and 9 months.
Results: Forty-three CH residents were randomly allocated to receive either the MPI or usual care. Median time to first fall (days) was longer in the MPI group compared to the control group (91 + 5.9 vs. 64 + 27.1), however this did not reach significance (Log Rank test, p = .41). A significant difference in the number of falls was found between the 2
groups, groups, favouring the MPI, directly after the 3 month intervention (p = .05, 95 % CI −1.59 to .36; mean falls MPI group 0.62 + 1.1 vs. mean falls control group 1.24 + 1.8) which translated to a medium effect size on the number of falls (Cohen’sd= .43). This significance disappeared following multiple imputation for missing data (p = .08, 95 % CI −1.39 to .31). There was no significant difference between the groups in the number of falls at the end of the 6-month follow up (p = .89, 95 % CI −1.26 to 1.22; mean falls MPI group 0.77 + 1.6 vs. mean falls control group 0.83 + 1.6). This translated to a small effect size (Cohen’s d = 0.06). Documented adherence to the exercise component of the MPI was poor, with 35 % of participants attempting the exercises 3 times per week.
Conclusion: Despite poor documented adherence, this work demonstrates a beneficial effect of the MPI on the time to first fall, and a beneficial effect size at the end of the intervention period. Our results suggest that participants adhering and completing the intervention protocol will benefit most from the intervention. If documented adherence can be improved the MPI has the potential to reduce falls in the CH setting. Based on these findings, a definitive multicentre RCT using the intervention and methods developed in this study is feasible and warranted.
Original language | English |
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Article number | B7.6 |
Pages (from-to) | 11 |
Number of pages | 1 |
Journal | Journal of Foot and Ankle Research |
Volume | 9 |
Issue number | Suppl 1 |
DOIs | |
Publication status | Published - 27 Apr 2016 |
Event | The College of Podiatry Annual Conference 2015 - Harrogate, United Kingdom Duration: 19 Nov 2015 → 21 Nov 2015 |