Clinical trial NCT06352749: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH)
Official title: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes: Randomized Controlled Trial on Its Effects on Health and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Function
Cognitive Decline
Psychological Well-Being
Keywords: physical exercise
online
nursing homes
older adults
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: Fundación Miranda
name: Residencia Albiz Santiago Llanos
name: Aspaldiko
name: Residencia Nuestra Señora de Begoña, Santurtzi
First posted: 2024-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group will be assigned to control, online intervention or face-to-face intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Older than 65 years
* A score equal to or higher than 15 out of 35 in the MEC-35 (Miniexamen Cognoscitivo) cognitive test
* A score equal to or higher than 50 out of 100 in the Barthel Index
* Able to stand-up and walk for 10 meters

Exclusion Criteria:

* Unstable Clinical Situation
* When the potential harms outweigh the benefits, according to the judgment of the healthcare personnel at the NHs

Primary outcomes:
measure: Trail Making Test (TMT)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Spanish Version of the Yesavage Depression Scale
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: 30-seconds Chair Sit to Stand test
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
Secondary outcomes:
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Wechsler Adult Intelligence Scale III (WAIS-III)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: EuroQol-5 dimensions (EQ-5D-5L)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Satisfaction with Life Scale
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Short Physical Performance Battery (SPPB)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: The Biceps Curl Test
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: The 2-minute Walk Test (2-MWT)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: The 8 Feet Up-and-Go test
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Handgrip strength test
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Brain Derived Neurotrophic Factor (BDNF)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Klotho
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Glucose
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Urea
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Creatinine
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Uric Acid
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Cholesterol
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Triglycerides
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum HDL-Cholesterol
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum LDL-Cholesterol
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Glutamate Pyruvate Transaminase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Glutamate Oxaloacetate Transaminase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum gamma glutamyl transferase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Alkaline Phosphatase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Creatin Kinase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Lactate Dehydrogenase
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Bilirubin
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Sodium
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Potassium
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Chloride
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum C Reactive Protein
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Albumin
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Total Protein
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Calcium
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum Phosphorus
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Serum D Vitamin
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Erythrocyte count
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Hemoglobin
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Hematocrit
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Mean Corpuscular Volume (MCV)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Mean Corpuscular Hemoglobin (MCH)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Mean Corpuscular Hemoglobin Concentration (MCHC)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Red Cell Distribution Width (RDW)
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Leucocyte Count
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Neutrophil Count and Percentage
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Lymphocyte Count and Percentage
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Monocyte Count and Percentage
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Eosinophil Count and Percentage
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Basophil Count and Percentage
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Platelet Count
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Platelet Mean Volumen
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Fried's frailty phenotype score
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Frail-NH frailty scale
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: The Pittsburgh Sleep Quality Index
timeFrame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
measure: Attendance rate
timeFrame: During 24 weeks of intervention
measure: Dose modification
timeFrame: During 24 weeks of intervention
measure: Adverse Events
timeFrame: During 24 weeks of intervention
Other outcomes:
Locations:
city: Portugalete
country: Spain
facility: Residencia Aspaldiko
state: Bizkaia
city: Santurtzi
country: Spain
facility: Residencia Nuestra Señora de Begoña
state: Bizkaia
city: Sestao
country: Spain
facility: Residencia Albiz Santiago LLanos
state: Bizkaia
city: Barakaldo
country: Spain
facility: Fundación Miranda
state: Vizcaya
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Jon Irazusta, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llinas-Regla J, Vilalta-Franch J, Lopez-Pousa S, Calvo-Perxas L, Torrents Rodas D, Garre-Olmo J. The Trail Making Test. Assessment. 2017 Mar;24(2):183-196. doi: 10.1177/1073191115602552. Epub 2016 Jul 28.
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citation: Moreno, J. A., González-Cutre, D., Chillón, M., y Parra, N. (2008). Adaptación a la educación física de la escala de las necesidades psicológicas básicas en el ejercicio. Revista Mexicana de Psicología, 25(2), 295-303
citation: Hernández-Pozo, M., Macías, D., Calleja, N., Cerezo, S., & del Valle Chauvet, C. (2008). Propiedades psicometricas del inventario Zung del estado de ansiedad con mexicanos. Psychologia. Avances de la disciplina, 2(2), 19-46.
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citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
citation: Kaehr E, Visvanathan R, Malmstrom TK, Morley JE. Frailty in nursing homes: the FRAIL-NH Scale. J Am Med Dir Assoc. 2015 Feb;16(2):87-9. doi: 10.1016/j.jamda.2014.12.002. Epub 2014 Dec 31. No abstract available.
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