nctId: NCT06352749 id: BasqueCU2024 briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH) acronym: ExerMOT-NH overallStatus: RECRUITING date: 2024-03-18 date: 2025-11-30 date: 2025-11-30 date: 2024-04-08 date: 2024-04-08 name: University of the Basque Country (UPV/EHU) class: OTHER name: Fundación Miranda name: Residencia Albiz Santiago Llanos name: Aspaldiko name: Residencia Nuestra Señora de Begoña, Santurtzi 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. conditions: Physical Function conditions: Cognitive Decline conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention primaryPurpose: SUPPORTIVE_CARE 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 count: 120 type: ESTIMATED name: Advice to increase physical activity and reduce sedentary behavior name: Online Physical Exercise name: Face-to-Face Exercise measure: Trail Making Test (TMT) measure: Spanish Version of the Yesavage Depression Scale measure: 30-seconds Chair Sit to Stand test measure: MoCA (Montreal Cognitive Assessment) measure: Wechsler Adult Intelligence Scale III (WAIS-III) measure: EuroQol-5 dimensions (EQ-5D-5L) measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008) measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008) measure: Satisfaction with Life Scale measure: Short Physical Performance Battery (SPPB) measure: The Biceps Curl Test measure: The 2-minute Walk Test (2-MWT) measure: The 8 Feet Up-and-Go test measure: Handgrip strength test measure: Serum Brain Derived Neurotrophic Factor (BDNF) measure: Serum Klotho measure: Serum Glucose measure: Serum Urea measure: Serum Creatinine measure: Serum Uric Acid measure: Serum Cholesterol measure: Serum Triglycerides measure: Serum HDL-Cholesterol measure: Serum LDL-Cholesterol measure: Serum Glutamate Pyruvate Transaminase measure: Serum Glutamate Oxaloacetate Transaminase measure: Serum gamma glutamyl transferase measure: Serum Alkaline Phosphatase measure: Serum Creatin Kinase measure: Serum Lactate Dehydrogenase measure: Serum Bilirubin measure: Serum Sodium measure: Serum Potassium measure: Serum Chloride measure: Serum C Reactive Protein measure: Serum Albumin measure: Serum Total Protein measure: Serum Calcium measure: Serum Phosphorus measure: Serum D Vitamin measure: Erythrocyte count measure: Hemoglobin measure: Hematocrit measure: Mean Corpuscular Volume (MCV) measure: Mean Corpuscular Hemoglobin (MCH) measure: Mean Corpuscular Hemoglobin Concentration (MCHC) measure: Red Cell Distribution Width (RDW) measure: Leucocyte Count measure: Neutrophil Count and Percentage measure: Lymphocyte Count and Percentage measure: Monocyte Count and Percentage measure: Eosinophil Count and Percentage measure: Basophil Count and Percentage measure: Platelet Count measure: Platelet Mean Volumen measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry measure: Fried's frailty phenotype score measure: Frail-NH frailty scale measure: The Pittsburgh Sleep Quality Index measure: Attendance rate measure: Dose modification measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Residencia Aspaldiko status: RECRUITING city: Portugalete state: Bizkaia zip: 48920 country: Spain name: Alvaro Mosquera role: CONTACT phone: 34-946250000 email: amosquera@aspaldiko.org lat: 43.32099 lon: -3.02064 facility: Residencia Nuestra Señora de Begoña status: NOT_YET_RECRUITING city: Santurtzi state: Bizkaia zip: 48980 country: Spain name: Janire R Ochoa role: CONTACT phone: 944836875 email: psicologa@residencia-santurtzi.com lat: 43.32842 lon: -3.03248 facility: Residencia Albiz Santiago LLanos status: NOT_YET_RECRUITING city: Sestao state: Bizkaia zip: 48910 country: Spain name: Olatz Larrinaga role: CONTACT phone: 946572220 email: direccion@residenciaalbiz.eus lat: 43.30975 lon: -3.00716 facility: Fundación Miranda status: NOT_YET_RECRUITING city: Barakaldo state: Vizcaya zip: 48902 country: Spain name: Celia Gómez role: CONTACT phone: 944382675 email: innovación@fundaciónmiranda.org lat: 43.29639 lon: -2.98813 hasResults: False