protocolSection identificationModule nctId: NCT06352749, orgStudyIdInfo id: BasqueCU2024, briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH), acronym: ExerMOT-NH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of the Basque Country (UPV/EHU), class: OTHER, collaborators name: Fundación Miranda, collaborators name: Residencia Albiz Santiago Llanos, collaborators name: Aspaldiko, collaborators name: Residencia Nuestra Señora de Begoña, Santurtzi, descriptionModule briefSummary: The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active., conditionsModule conditions: Physical Function, conditions: Cognitive Decline, conditions: Psychological Well-Being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Advice to increase physical activity and reduce sedentary behavior, interventions name: Online Physical Exercise, interventions name: Face-to-Face Exercise, outcomesModule primaryOutcomes measure: Trail Making Test (TMT), primaryOutcomes measure: Spanish Version of the Yesavage Depression Scale, primaryOutcomes measure: 30-seconds Chair Sit to Stand test, secondaryOutcomes measure: MoCA (Montreal Cognitive Assessment), secondaryOutcomes measure: Wechsler Adult Intelligence Scale III (WAIS-III), secondaryOutcomes measure: EuroQol-5 dimensions (EQ-5D-5L), secondaryOutcomes measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008), secondaryOutcomes measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008), secondaryOutcomes measure: Satisfaction with Life Scale, secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: The Biceps Curl Test, secondaryOutcomes measure: The 2-minute Walk Test (2-MWT), secondaryOutcomes measure: The 8 Feet Up-and-Go test, secondaryOutcomes measure: Handgrip strength test, secondaryOutcomes measure: Serum Brain Derived Neurotrophic Factor (BDNF), secondaryOutcomes measure: Serum Klotho, secondaryOutcomes measure: Serum Glucose, secondaryOutcomes measure: Serum Urea, secondaryOutcomes measure: Serum Creatinine, secondaryOutcomes measure: Serum Uric Acid, secondaryOutcomes measure: Serum Cholesterol, secondaryOutcomes measure: Serum Triglycerides, secondaryOutcomes measure: Serum HDL-Cholesterol, secondaryOutcomes measure: Serum LDL-Cholesterol, secondaryOutcomes measure: Serum Glutamate Pyruvate Transaminase, secondaryOutcomes measure: Serum Glutamate Oxaloacetate Transaminase, secondaryOutcomes measure: Serum gamma glutamyl transferase, secondaryOutcomes measure: Serum Alkaline Phosphatase, secondaryOutcomes measure: Serum Creatin Kinase, secondaryOutcomes measure: Serum Lactate Dehydrogenase, secondaryOutcomes measure: Serum Bilirubin, secondaryOutcomes measure: Serum Sodium, secondaryOutcomes measure: Serum Potassium, secondaryOutcomes measure: Serum Chloride, secondaryOutcomes measure: Serum C Reactive Protein, secondaryOutcomes measure: Serum Albumin, secondaryOutcomes measure: Serum Total Protein, secondaryOutcomes measure: Serum Calcium, secondaryOutcomes measure: Serum Phosphorus, secondaryOutcomes measure: Serum D Vitamin, secondaryOutcomes measure: Erythrocyte count, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Mean Corpuscular Volume (MCV), secondaryOutcomes measure: Mean Corpuscular Hemoglobin (MCH), secondaryOutcomes measure: Mean Corpuscular Hemoglobin Concentration (MCHC), secondaryOutcomes measure: Red Cell Distribution Width (RDW), secondaryOutcomes measure: Leucocyte Count, secondaryOutcomes measure: Neutrophil Count and Percentage, secondaryOutcomes measure: Lymphocyte Count and Percentage, secondaryOutcomes measure: Monocyte Count and Percentage, secondaryOutcomes measure: Eosinophil Count and Percentage, secondaryOutcomes measure: Basophil Count and Percentage, secondaryOutcomes measure: Platelet Count, secondaryOutcomes measure: Platelet Mean Volumen, secondaryOutcomes measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry, secondaryOutcomes measure: Fried's frailty phenotype score, secondaryOutcomes measure: Frail-NH frailty scale, secondaryOutcomes measure: The Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Attendance rate, secondaryOutcomes measure: Dose modification, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Residencia Aspaldiko, status: RECRUITING, city: Portugalete, state: Bizkaia, zip: 48920, country: Spain, contacts name: Alvaro Mosquera, role: CONTACT, phone: 34-946250000, email: amosquera@aspaldiko.org, geoPoint lat: 43.32099, lon: -3.02064, locations facility: Residencia Nuestra Señora de Begoña, status: NOT_YET_RECRUITING, city: Santurtzi, state: Bizkaia, zip: 48980, country: Spain, contacts name: Janire R Ochoa, role: CONTACT, phone: 944836875, email: psicologa@residencia-santurtzi.com, geoPoint lat: 43.32842, lon: -3.03248, locations facility: Residencia Albiz Santiago LLanos, status: NOT_YET_RECRUITING, city: Sestao, state: Bizkaia, zip: 48910, country: Spain, contacts name: Olatz Larrinaga, role: CONTACT, phone: 946572220, email: direccion@residenciaalbiz.eus, geoPoint lat: 43.30975, lon: -3.00716, locations facility: Fundación Miranda, status: NOT_YET_RECRUITING, city: Barakaldo, state: Vizcaya, zip: 48902, country: Spain, contacts name: Celia Gómez, role: CONTACT, phone: 944382675, email: innovación@fundaciónmiranda.org, geoPoint lat: 43.29639, lon: -2.98813, hasResults: False