Effects of a Home-Based Foot-Ankle Exercise Program with Educational Booklet for Foot Dysfunctions in People with Diabetic Neuropathy: Results of the FOCA-II Randomized Controlled Clinical Trial

Exercise rehabilitation and education are important strategies for preventing the progression of diabetic neuropathy-related musculoskeletal deficits. The purpose of this randomized controlled trial was to investigate the effect of an 8-week home-based foot-ankle exercise program using an educational booklet on clinical outcomes (foot muscle strength and functionality; functional balance; diabetic neuropathy symptoms and severity; tactile and vibratory sensitivities; plantar pressure distribution; and foot-ankle, knee, and hip biomechanics during gait). Fifty participants with neuropathy were randomly allocated into an intervention group (59.1 +/- 6.4 years, 23.5 +/- 4.8 kg/m(2), males = 6, females = 19) that performed the exercises for 8 weeks and a control group (56.5 +/- 9.4 years, 22.9 +/- 3.6 kg/m(2), males = 5, females = 20) that received usual care recommendations. Generalized estimating equation method and intention-to-treat approaches were adopted. No significant differences were found for any clinical outcome after 8 weeks. Heel contact area increased in the intervention group compared to controls (p = 0.043, mean difference = 2.7 cm) and heel peak pressure was increased in controls compared to intervention (group effect p = 0.020, mean difference = -64.16 kPa) at 8 weeks. Controls showed increased joint moments for the hip at heel strike (p = 0.007) and for the knee and hip at push off over 8 and 16 weeks (p < 0.001 and p = 0.009, respectively). Although the intervention is easy to perform and showed a good adherence (72%), home-based foot-ankle exercise programs are unlikely to sufficiently modify the main risk factors related to foot ulcers and to change foot-ankle kinematics and kinetics.

Automated summary

Exercise rehabilitation and education are important for preventing the progression of diabetic neuropathy-related deficits. This study investigated the effect of an 8-week home-based exercise program on various clinical outcomes in 50 participants with neuropathy. The results showed no significant differences in clinical outcomes after 8 weeks, but certain differences in foot-ankle biomechanics and joint moments were observed between the intervention and control groups.