The primary outcomes were measured changes in HRQoL, secondary outcomes were related to functional activities. The latter were timed up-and-go [TUG] (>stand> walk > return), five times sit-to-stand [FTSTS], functional reach, static balance, ankle muscle strength and knee range of motion) and balance confidence. The control arm received no interventions except standard medical diabetes care. Outcomes measures were obtained over a 6-month period at baseline, 2 and 6 months by an independent, thus blinded, trained assessor. The exercise programme was taught by a physiotherapist on a 1-1 basis with subjects encouraged to perform the exercises daily or at least three times weekly. At each assessment, HRQoL (including PCS and EQ5-5L index scores) questionnaires were completed, functional measures including body sway, joint range of movement, muscle strength etc were objectively recorded by a trained independent assessor blinded to randomisation. Mean differences in scores between groups were compared using mixed models. Of the 143 participants randomised (intervention, n=70; control n=73), 67 participants were included in each arm for the final intention-to-treat analysis as nine subjects were lost to follow-up.
The mean subject age was 62 years, 56% (n=80) were women and 77% were of South Asian ethnicity. Mean diabetes duration was 15.3 years (SD 10.7) with a mean HbA1c of 8.5% and BMI of 28.4 (SD 5.7). Both groups were demographically and clinically comparable except more women were in the control group. The intervention group completed a reported a median of 25 days (range 0–49 days) of completed home exercises. There were no significant differences between groups on the primary outcomes of PCS score (mean difference [MD] 1.56 [95% CI −1.75, 4.87]; P=0.355) and EQ5D-5L index score (MD 0.02 [95% CI−0.01, 0.06]; P=0.175). However, there were significant improvements in TUG test performance (MD−1.14[95% CI−2.18,−0.1] s;P=0.032), FTSTS test performance (MD−1.31 [95% CI−2.12,−0.51] s;P=0.001), ankle muscle strength (MD 4.18 [95% CI 0.4, 7.92] N; P=0.031), knee range of motion (MD 6.82 [95% CI 2.87, 10.78]°; P=0.001) and balance confidence score (MD 6.17 [95% CI 1.89, 10.44]; P=0.005).
This study demonstrated that short-term structured strength and balance training resulted in sustained improvements in functional status at 6 months in individuals with DPN. However, these did not appear to have to impact on HRQoL. The principal limitations of this study include: no measure of severity of DPN, the study numbers and duration of follow-up were too low to demonstrate long term effects. The body pain component of HRQoL does not account for painful neuropathy. It would be interesting to repeat this study in other ethnic groups as the joint range of motion, lifestyles maybe significantly different in other regions of the world.
Despite this, for me, it stimulates several thoughts; we should consider more active physiotherapy involvement — can we preserve functional status, improve balance confidence and reduce the likelihood of falls and injuries in individuals with DPN?
