Effects of foot muscle strengthening in daily activity and functionality of foot and ankle in diabetic polyneuropathy patients: a randomized controlled trial

• Grant number: 17/17848-3
• Support Opportunities: Scholarships in Brazil - Doctorate
• Effective date (Start): June 01, 2018
• Effective date (End): May 31, 2021
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Isabel de Camargo Neves Sacco
• Grantee: Renan Lima Monteiro
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Considering the several alterations of the feet and ankles present in patients with diabetic polyneuropathy (DPN) and that such changes directly affect the reduction of daily physical activity, the inclusion of a protocol to strengthen the muscles of the feet can be presented as an efficient method to physical therapy treatment, since such exercises aim specifically to strengthen the muscles compromised by DPN. Thus, the inclusion of an exercise protocol for the strengthening of the intrinsic and extrinsic musculature of the feet may add additional effects to the physiotherapeutic interventions. The aim of the present study was to investigate the effects of foot muscle strengthening on daily physical activity levels and walking speed at the end of 12 weeks of study and after one year of follow-up of patients with DPN. A prospective, parallel controlled, randomized trial and blinding of the evaluators will be conducted with 77 patients with DPN up to 75 years old who will be randomly divided into the control or intervention groups, and the latter will receive physical therapy intervention in person 2 times a week for 12 weeks and via Software de orientação ao pé diabético (SOPED) 2 times a week during one year of study. The subjects will be evaluated in 5 moments regarding daily physical activity level, self-selected and rapid gait speed, incidence of foot ulcers, risk of developing ulcer, symptoms, tactile and vibratory feet sensitivity, range of passive movement and foot muscle strength. The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion and increased isometric strength of the feet compared to the control group after 12 weeks of intervention and follow-up year. (AU)

Scientific publications

(12)

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

ZIPPENFENNIG, CLAUDIO; DRECHSEL, TINA J.; MONTEIRO, RENAN L.; SACCO, ISABEL C. N.; MILANI, THOMAS L.. The Mechanoreceptor's Role in Plantar Skin Changes in Individuals with Diabetes Mellitus. JOURNAL OF CLINICAL MEDICINE, v. 10, n. 12, JUN 2021. (17/17848-3)

MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; CRUVINEL-JUNIOR, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. SCIENTIFIC REPORTS, v. 12, n. 1, p. 12-pg., 2022-05-09. (17/17848-3, 19/06405-9, 19/02522-0)

DRECHSEL, TINA J.; MONTEIRO, RENAN L.; ZIPPENFENNIG, CLAUDIO; FERREIRA, JANE S. S. P.; MILANI, THOMAS L.; SACCO, ISABEL C. N.. Low and High Frequency Vibration Perception Thresholds Can Improve the Diagnosis of Diabetic Neuropathy. JOURNAL OF CLINICAL MEDICINE, v. 10, n. 14, JUL 2021. (17/17848-3)

MONTEIRO, RENAN L.; SARTOR, CRISTINA D.; FERREIRA, JANE S. S. P.; DANTAS, MILLA G. B.; BUS, SICCO A.; SACCO, ISABEL C. N.. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC MUSCULOSKELETAL DISORDERS, v. 19, NOV 14 2018. (17/17848-3)

SILVA, ERICA Q.; SANTOS, DANILO P.; BETELI, RAQUEL I.; MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; CRUVINEL-JUNIOR, RONALDO H.; DONINI, ASHA; VERISSIMO, JADY L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. SCIENTIFIC REPORTS, v. 11, n. 1, JUN 11 2021. (19/02624-8, 17/15449-4, 19/02522-0, 17/17848-3, 19/06405-9)

CRUVINEL-JUNIOR, RONALDO H. H.; FERREIRA, JANE S. S. P.; VERISSIMO, JADY L.; MONTEIRO, RENAN L. L.; SUDA, ENEIDA Y. Y.; SILVA, ERICA Q.; SACCO, ISABEL C. N.. Could an Internet-Based Foot-Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study. SENSORS, v. 22, n. 24, p. 17-pg., 2022-12-01. (19/02522-0, 21/00807-8, 17/17848-3, 17/15449-4)

FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; SILVA, E. Q.; VERISSIMO, J. L.; MONTEIRO, R. L.; PEREIRA, D. S.; SUDA, E. Y.; SARTOR, C. D.; SACCO, I. C. N.. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials, v. 21, n. 1, JAN 13 2020. (19/02624-8, 17/17848-3, 17/15449-4, 19/02522-0)

SILVA, E. Q.; SUDA, E. Y.; SANTOS, D. P.; VERISSIMO, J. L.; FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; MONTEIRO, R. L.; SARTOR, C. D.; SACCO, I. C. N.. Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial. Trials, v. 21, n. 1, FEB 13 2020. (19/02624-8, 19/06405-9, 17/15449-4, 17/17848-3, 19/02522-0)

MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; CRUVINEL, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial. BRAZILIAN JOURNAL OF PHYSICAL THERAPY, v. 27, n. 3, p. 11-pg., 2023-05-01. (19/02522-0, 21/00807-8, 17/17848-3)

MONTEIRO, RENAN L.; FERREIRA, JANE S. S. P.; SILVA, ERICA Q.; DONINI, ASHA; CRUVINEL-JUNIOR, RONALDO H.; VERISSIMO, JADY L.; BUS, SICCO A.; SACCO, ISABEL C. N.. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. SENSORS, v. 20, n. 18, p. 18-pg., 2020-09-01. (19/06405-9, 17/17848-3, 19/02522-0)

CRUVINEL JUNIOR, RONALDO H.; FERREIRA, JANE S. S. P.; BETELI, I, RAQUEL; SILVA, ERICA Q.; VERISSIMO, JADY L.; MONTEIRO, RENAN L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I. PILOT AND FEASIBILITY STUDIES, v. 7, n. 1, MAR 26 2021. (17/15449-4, 19/06405-9, 19/02522-0, 17/17848-3)

SILVA, ERICA Q.; VERISSIMO, JADY L.; FERREIRA, JANE S. S. P.; CRUVINEL-JUNIOR, RONALDO H.; MONTEIRO, RENAN L.; SUDA, ENEIDA Y.; SACCO, ISABEL C. N.. 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. APPLIED SCIENCES-BASEL, v. 13, n. 3, p. 15-pg., 2023-02-01. (19/02522-0, 21/00807-8, 17/17848-3)

Academic Publications

(References retrieved automatically from State of São Paulo Research Institutions)

MONTEIRO, Renan Lima. Effects of foot muscle strengthening on physical activity of daily living and ankle and foot functionality in people with diabetic polyneuropathy: a randomized controlled clinical trial. 2021. Doctoral Thesis - Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD) São Paulo.