Ronaldo H Cruvinel Júnior1, Jane S S P Ferreira1, Raquel I Beteli1, Érica Q Silva1, Jady L Veríssimo1, Renan L Monteiro1,2, Eneida Y Suda1,3, Isabel C N Sacco4. 1. Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil. 2. Department of Physical Therapy, Federal University of Amapá, Amapá, Brazil. 3. Department of Physical Therapy, Ibirapuera University, São Paulo, SP, Brazil. 4. Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil. icnsacco@usp.br.
Abstract
BACKGROUND: Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD). METHODS:Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group. RESULTS: In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0). CONCLUSION: The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04011267 . Registered on 8 July 2019.
RCT Entities:
BACKGROUND:Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD). METHODS: Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group. RESULTS: In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0). CONCLUSION: The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04011267 . Registered on 8 July 2019.
Authors: Aline A Gomes; Andrea N Onodera; Mitie E I Otuzi; Denise Pripas; Rinaldo André Mezzarane; Isabel C N Sacco Journal: Muscle Nerve Date: 2011-08 Impact factor: 3.217
Authors: R Mahieu; M N O Coenen; T van Bemmel; H J van der Zaag-Loonen; W J Theuvenet Journal: Diabetes Res Clin Pract Date: 2016-07-28 Impact factor: 5.602
Authors: Plaiwan Suttanon; Keith D Hill; Catherine M Said; Susan B Williams; Karin N Byrne; Dina LoGiudice; Nicola T Lautenschlager; Karen J Dodd Journal: Clin Rehabil Date: 2012-11-01 Impact factor: 3.477
Authors: Emma Appleby; Sophie Taylor Gill; Lucinda Kate Hayes; Tessa Lauren Walker; Matt Walsh; Saravana Kumar Journal: PLoS One Date: 2019-11-12 Impact factor: 3.240