The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial.

BACKGROUND: Stroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that inspiratory and expiratory respiratory muscle training (IEMT) can improve swallowing efficacy and may reduce aspiration events. The main purpose of this study is to examine whether an 8-week IEMT programme can improve respiratory muscle strength and swallow dysfunction severity in subacute stroke patients with dysphagia. METHODS: Retornus-2 is a two-arm, prospectively registered, randomized controlled study with blinded assessors and the participation of fifty individuals who have suffered a stroke. The intervention group undergoes IEMT training consisting of 5 sets of 10 repetitions, three times a day for 8 weeks. Training loads increase weekly. The control group undergoes a sham-IEMT protocol. The primary outcome examines the efficacy of the IEMT protocol to increase respiratory muscle strength and reduce dysphagia severity. The secondary outcome assesses the longitudinal impact of dysphagia on body composition and nutritional assessment over a 6-month follow-up. DISCUSSION: IEMT induces an improvement in respiratory muscle strength and might be associated with relevant benefits in dysphagia patterns, as well as a reduction in the number of aspiration events confirmed by videofluoroscopy or fiberoptic endoscopic evaluation of swallowing. The description of the impact of swallowing impairment on nutritional status will help develop new strategies to face this known side-effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT03021252. Registered on 10 January 2017. https://clinicaltrials.gov/ct2/results?cond=retornus+2&term=&cntry=ES&state=&city=&dist= WHO trial Registration data set: Due to heavy traffic generated by the COVID-19 outbreak, the ICTRP Search Portal does not respond. The portal recommends other registries such as clinicaltrials.gov. Protocol version: RETORNUS 2_ PROTOCOL_2.

Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People.

OBJECTIVES: The revised European consensus on sarcopenia definition and diagnosis (EWGSOP2) includes the SARC-F questionnaire, the most valid and consistent sarcopenia screening tool, as the mandatory first step. Our aim was the translation, cross-cultural adaptation, and validation of the SARC-F questionnaire as a culturally-responsive Spanish-language version for the European population. STUDY DESIGN: Cross-sectional descriptive study, applying the two-step WHO methodology for translation and cross-cultural adaptation of health questionnaires, and harmonization with the Mexican-Spanish version. European Union Geriatric Medicine Society recommendations for SARC-F validation in European languages were considered. PARTICIPANTS: Outpatient clinics of a university hospital. INCLUSION CRITERIA: stable, ambulatory (including aids), community-dwelling population ≥65 years old. MAIN OUTCOME MEASURES: The self-reported 5-item SARC-F questionnaire was administered; scores ≥4 indicated sarcopenia. Sensitivity, specificity, accuracy-likelihood ratios, predictive values, and kappa statistics were calculated and consecutively compared with European Working Group on Sarcopenia in Older People (EWGSOP) and EWGSOP2 criteria. RESULTS: This Spanish version, administered in an average 70s, has adequate internal consistency (Cronbach alpha=0.779). For the validation study, 90 (43.3%) of 208 potentially eligible subjects (81.4 ± 5.9 years old, 75.6% women) were included. SARC-F identified 51 (56.7%) subjects with sarcopenia and 39 (43.3%) without the disease. Prevalence was 17.8% per EWGSOP and 25.6% per EWGSOP2 (58% accuracy and fair agreement: sensitivity, 78.3%; specificity, 50.8%). CONCLUSIONS: SARC-F is a feasible tool, suitable for bedside assessment in community-dwelling older patients. Wide diffusion of this culturally-responsible SARC-F Spanish version is expected as EWGSOP2 is adopted and sarcopenia assessment is broadly implemented in Spain.