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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Author(s):
Silva, Erica Q. [1] ; Santos, Danilo P. [1] ; Beteli, Raquel I. [1] ; Monteiro, Renan L. [2, 1] ; Ferreira, Jane S. S. P. [1] ; Cruvinel-Junior, Ronaldo H. [1] ; Donini, Asha [1] ; Verissimo, Jady L. [1] ; Suda, Eneida Y. [3, 1] ; Sacco, Isabel C. N. [1]
Total Authors: 10
Affiliation:
[1] Univ Sao Paulo, Dept Phys Therapy Speech & Occupat Therapy, Fac Med, Rua Cipotanea 51, Cidade Univ, BR-05360160 Sao Paulo, SP - Brazil
[2] Univ Fed Amapa, Dept Phys Therapy, Amapa - Brazil
[3] Univ Ibirapuera, Dept Phys Therapy, Sao Paulo, SP - Brazil
Total Affiliations: 3
Document type: Journal article
Source: SCIENTIFIC REPORTS; v. 11, n. 1 JUN 11 2021.
Web of Science Citations: 0
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. (AU)

FAPESP's process: 19/02624-8 - Effect of the use of a rehabilitation technology tool for self-care, prevention and treatment of the foot of people with diabetes mellitus: randomized controlled trial
Grantee:Danilo Pereira dos Santos
Support type: Scholarships in Brazil - Scientific Initiation
FAPESP's process: 17/15449-4 - Biomechanical and functional aspects of the musculoskeletal system of runners: chronic effects of therapeutic exercise and aging
Grantee:Eneida Yuri Suda
Support type: Scholarships in Brazil - Post-Doctorate
FAPESP's process: 19/02522-0 - Rehabilitation technology for prevention of musculoskeletal and foot dysfunctions of people with Diabetes Mellitus: FootCAre (FoCa) prevention randomized controlled trial
Grantee:Jane Suelen Silva Pires Ferreira
Support type: Scholarships in Brazil - Doctorate
FAPESP's process: 17/17848-3 - Effects of foot muscle strengthening in daily activity and functionality of foot and ankle in diabetic polyneuropathy patients: a randomized controlled trial
Grantee:Renan Lima Monteiro
Support type: Scholarships in Brazil - Doctorate
FAPESP's process: 19/06405-9 - Rehabilitation technology for prevention of musculoskeletal dysfunctions and treatment of people's feet with diabetes mellitus: study FOotCAre (FOCA) proof of concept
Grantee:Ronaldo Henrique Cruvinel Júnior
Support type: Scholarships in Brazil - Master