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...
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2021
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oai:doaj.org-article:65b2387a2b6b48eaadfbdcb7a8b3c49b2021-12-02T17:47:18ZFeasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II10.1038/s41598-021-91901-02045-2322https://doaj.org/article/65b2387a2b6b48eaadfbdcb7a8b3c49b2021-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-91901-0https://doaj.org/toc/2045-2322Abstract 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 .Érica Q. SilvaDanilo P. SantosRaquel I. BeteliRenan L. MonteiroJane S. S. P. FerreiraRonaldo H. Cruvinel-JuniorAsha DoniniJady L. VerissímoEneida Y. SudaIsabel C. N. SaccoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021) |
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Medicine R Science Q Érica Q. Silva Danilo P. Santos Raquel I. Beteli Renan L. Monteiro Jane S. S. P. Ferreira Ronaldo H. Cruvinel-Junior Asha Donini Jady L. Verissímo Eneida Y. Suda Isabel C. N. Sacco Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| description |
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 . |
| format |
article |
| author |
Érica Q. Silva Danilo P. Santos Raquel I. Beteli Renan L. Monteiro Jane S. S. P. Ferreira Ronaldo H. Cruvinel-Junior Asha Donini Jady L. Verissímo Eneida Y. Suda Isabel C. N. Sacco |
| author_facet |
Érica Q. Silva Danilo P. Santos Raquel I. Beteli Renan L. Monteiro Jane S. S. P. Ferreira Ronaldo H. Cruvinel-Junior Asha Donini Jady L. Verissímo Eneida Y. Suda Isabel C. N. Sacco |
| author_sort |
Érica Q. Silva |
| title |
Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| title_short |
Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| title_full |
Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| title_fullStr |
Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| title_full_unstemmed |
Feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II |
| title_sort |
feasibility of a home-based foot–ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled footcare (foca) trial ii |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/65b2387a2b6b48eaadfbdcb7a8b3c49b |
| work_keys_str_mv |
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1718379470859010048 |