Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II

Abstract

This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. In the IG, we assessed preliminary changes in DPN symptoms, DPN severity (classified by a fuzzy model) and foot-ankle range of motion between baseline and Week 8. In the first 20 weeks, 1310 individuals were screened for eligibility by phone contact. Contact rate was 89% (contacted participants/20w), preliminary screening success 28% (participants underwent screening/20w), and recruitment rate 1.0 participants/week (eligible participants/20w). The recruitment rate was less than the ideal rate of 5 participants/week. The adherence to the exercises programme was 77%, and the dropout was 11% and 9% for the IG and CG, respectively. In the IG, participants' median level of satisfaction was 4 (IQR: 4-5) and perceived safety was 3 (IQR: 3-5). IG significantly decreased the DPN severity (p = 0.020), increased hallux relative to forefoot (first metatarsal) range of motion (ROM) (p < 0.001) and decreased maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait (p = 0.029). The home-based programme was feasible, satisfactory, safe and showed preliminary positive changes in DPN severity and foot motion during gait.Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745 .

Figure 1

Flow chart of the feasibility study explaining reasons for inclusion and exclusion. T8 evaluation at 8 weeks, DM diabetes mellitus, DPN diabetic peripheral neuropathy.

Figure 2

Exercise dose. The general exercise progression from all IG participants from each session (columns) and the volume (repetitions) (blue line) of total workout exercises.

Figure 3

Ensemble averaged kinematics of the hallux (HXFFA), forefoot (FFHFA) and hindfoot (HFTBA) joints in degrees (deg) relative to the proximal segment from de IG participants. Royal blue color indicates baseline assessment (T00), dark blue color indicates Week 8 assessment (T08). Error bars represent standard error. FS indicates foot strike, vertical lines (FO) indicate foot off event in the gait cycle.

Figure 4

A sample of pages from the booklet. (A) exercise programme, (B) level of difficulty and (C) monthly-calendar. The booklet was created using Adobe Photoshop cs5 Windows (https://www.adobe.com/br/products/photoshop.html) and Microsoft PowerPoint to Microsoft 365 version 2104 and the pictures that make up the figure are from the authors' personal collection.