1. Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II
- Author
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Danilo Pereira dos Santos, Asha Donini, Isabel C. N. Sacco, Érica Q. Silva, Raquel I. Beteli, Jane S. S. P. Ferreira, Jady L. Verissímo, Ronaldo H. Cruvinel-Júnior, Renan L. Monteiro, and Eneida Yuri Suda
- Subjects
Quality of life ,medicine.medical_specialty ,Disease prevention ,Science ,030209 endocrinology & metabolism ,Article ,03 medical and health sciences ,0302 clinical medicine ,Diabetic Neuropathies ,Diabetes mellitus ,Medicine ,Humans ,Single-Blind Method ,Musculoskeletal Diseases ,Exercise ,Gait ,Physical Therapy Modalities ,Multidisciplinary ,business.industry ,Foot ,Forefoot ,Endocrine system and metabolic diseases ,Patient education ,medicine.disease ,Home based ,Home Care Services ,Biomechanical Phenomena ,medicine.anatomical_structure ,Peripheral neuropathy ,Neurological manifestations ,Physical therapy ,Feasibility Studies ,Patient Compliance ,Ankle ,business ,Range of motion ,030217 neurology & neurosurgery ,Foot (unit) - 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 Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745.
- Published
- 2021