## 4 Discussion  
The objective of FOCA-II trial was to examine the effectiveness of a 8-week home-based foot-ankle exercise program based on an educational booklet. Overall, 8 weeks of intervention compared to the usual care did not result in any improvement in the primary outcomes (DPN severity and symptoms). Concerning the secondary outcomes, after 8 weeks, the IG participants compared to the control group showed an increase in the heel contact area, in the control group participants compared to IG were observed an increase in the peak pressure at the heel and in the hip flexor moment, and there were important changes in the hip extensor and knee flexor moments during gait in the control group between weeks 8 and 16. Although the DPN-related outcomes' changes to the participants post-intervention were disappointing, a recent randomized trial that investigated the effect of a 12-week group-based foot-ankle exercise program did not find any changes in DPN symptoms but observed changes in vibration sensitivity [25]. Two trials using a home-based foot-ankle and lower limb exercise program found significant improvements in DPN symptoms [16; 42], but others did not show improvements in vibration sensitivity [19]. Therefore, the evidence for the effectiveness of home-based foot-related exercises in clinical DPN-related parameters remains unclear, even with this new evidence provided by our study. Thus, further studies using different training modalities (group-based, face-to-face, home-based, and one-on-one training) are warranted to determine if exercises targeting DPN musculoskeletal deficits could favorably change clinical outcomes (symptoms and sensitivity). Our intervention failed to prove its effectiveness for increasing foot strength. Other trials developed using home-based foot-ankle exercises did not assess foot strength [16; 21; 42; 43], making it difficult to conclude if the modality of the intervention is the reason for the lack of effect, especially considering [PERSON] et al. 's (2022) [25] results, which used group face-to-face training and no differences were reported. Changes in foot strength following different modalities were found for a 12-week face-to-face program [18], 12-week group-based program focusing on balance training [29], and 12-week mixed (face-to-face and home-based) intervention [23]. Thus, the shorter duration of our program (8 weeks) and modality of the intervention (home-based) might be explaining the lack of effect. Further studies are required to improve the body of evidence for foot-strengthening programs. Plantar pressure during gait did not change over time. It is well established that plantar pressure monitoring is of paramount importance in people with DPN because high peak pressure is a well-established risk factor for ulcers [44]. Our study revealed a positive outcome in the IG participants after the intervention, showing a significant between-group increase in the contact area during gait; whereas there was a negative outcome for the  
Figure 2: (**A**) Mean time series of the hip flexor moment during gait of the intervention group at baseline (T00) and 8 weeks (T08). (**B**) Mean time series of the hip flexor moment during gait of the control group at baseline (T00) and 8 weeks (T08). The dotted lines correspond to end of the propulsion phase/beginning of the swing phase of gait. control group participants, in which the peak pressure at the heel increased after 8 weeks. [PERSON] et al. (2016) [22] found an increase in the heel contact area as a result of an 8-week face-to-face program of lower limb and foot-ankle exercises in persons with DPN. This finding might support the hypothesis of an improved foot rollover in the IG participants in our study, as the exercises may have interfered with the subtalar motion that influences the progression of the contact of the sole of the foot to the floor during stance, thus changing the contact area [7].