Clinical trial NCT06974006: Life Monitoring for Rural Older Adults
Official title: Integrated Monitoring for Independent Living in Rural Settings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aged 60 Years or Older
Keywords: Older adults
Frailty
Physical fitness
Prevention
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults (≥60 years old) with or without chronic diseases living in rural areas of Valladolid

Brief summary: Aging is a biological process that is accompanied by a progressive deterioration of physical and mental abilities and leads to an increased risk of disease. In 2023, Spain will reach an all-time high aging rate of 137.7% due to the low birth rate and increasing life expectancy. In Castilla y León, 47.57% of the population lives in municipalities with fewer than 20,000 inhabitants. This percentage has decreased over the last 10 years, reflecting a clear trend towards rural exodus, and this population loss requires the development of specific measures. Spanish Law 45/2007 includes as one of its objectives the promotion of quality social services and the guarantee of access to public services for older adults. However, geographical dispersion limits the effective implementation of these services. Although Castilla y León has a good network of local clinics, medical care in many municipalities is outpatient and limited to a weekly consultation. This low frequency of face-to-face care hinders the early detection of diseases, leads to a greater number of avoidable hospitalizations and contributes to older adults isolation. Faced with this reality, the VIVIR (Integrated Monitoring for Independent Living in Rural Settings) project proposes the implementation of an innovative system for the continuous monitoring of the health status of the elderly through an advanced comprehensive assessment kit. This kit will include instruments such as electrocardiogram, blood pressure measurement, manual grip strength, assessment of physical and emotional functions, spirometry, body composition and nutritional assessment.

Detailed description: Advances in disease prevention and treatment as well as social changes have led to an increase in life expectancy of around 10-20 years in various regions of the world since the 1950s. However, population growth and aging have led to a sharp increase in the number of older people with physical disabilities, i.e. with difficulties in performing activities of daily living. Aging is defined as a biological process characterized by an increasing accumulation of cellular and molecular damage that leads to a decrease in physical and mental abilities and thus to an increased risk of disease. Currently, more than half of the population in the European Union is 65 years old or older. Furthermore, projections for 2050 indicate a decrease in the ratio of working-age people to older people, reflecting the increasing aging of the European population. In 2023, Spain will reach the historical peak of aging with 137.7% of the population. These demographic changes are also expected to increase the number of age-related diseases and conditions, including frailty. Frailty can be defined as a syndrome caused by the combined effect of multiple age-related and associated changes. Specifically, phenotypic frailty is a validated clinical presentation that marks a distinct clinical syndrome and pathophysiology. Furthermore, the 'Frailty Index' calculates the percentage of clinically identified conditions or impairments in relation to the number of measured diseases, symptoms, signs, impairments, disabilities and functional limitations, social environment, physical activity, mental health, cognitive status, self-assessed health and, in some cases, laboratory findings. A preventive assessment together with the implementation of a care and follow-up plan can have benefits for the well-being and independence of older adults, including reduced hospital admissions, falls and long-term mortality.

Eligibility criteria: Inclusion Criteria:

* People living in rural areas of less than 20,000 inhabitants belonging to the Diputación de Valladolid.
* People aged 60 years or older.

Exclusion Criteria:

* People with cognitive impairment and difficulty in understanding and responding to verbal commands.
* People who have been admitted to hospital for more than or equal to one week in the last month prior to inclusion in the study.

Primary outcomes:
measure: Electrocardiogram (ECG)
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Blood pressure
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Oxygen saturation
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Spirometry
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Bioimpedance
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Nutritional assessment
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Handgrip strength
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Short Physical Performance Battery (SPPB)
timeFrame: Visits 1, 2, 3 and 4
Secondary outcomes:
measure: Frailty phenotype
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
measure: Sarcopenia detection
timeFrame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
Other outcomes:
measure: Telephone follow-up
timeFrame: Phone calls every two weeks during the seven months of study
Locations:
city: Valladolid
country: Spain
facility: Miguel de Cervantes European University
city: Valladolid
country: Spain
facility: Miguel de Cervantes European University
Study officials:
affiliation: Miguel de Cervanyes European University
name: Susana López Ortiz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
citation: Roman Vinas B, Ribas Barba L, Ngo J, Serra Majem L. [Validity of the international physical activity questionnaire in the Catalan population (Spain)]. Gac Sanit. 2013 May-Jun;27(3):254-7. doi: 10.1016/j.gaceta.2012.05.013. Epub 2012 Oct 24. Spanish.
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: Ortega Orcos R, Salinero Fort MA, Kazemzadeh Khajoui A, Vidal Aparicio S, de Dios del Valle R. [Validation of 5 and 15 items Spanish version of the geriatric depression scale in elderly subjects in primary health care setting]. Rev Clin Esp. 2007 Dec;207(11):559-62. doi: 10.1157/13111585. Spanish.
citation: Kameniar K, Mackintosh S, Van Kessel G, Kumar S. The Psychometric Properties of the Short Physical Performance Battery to Assess Physical Performance in Older Adults: A Systematic Review. J Geriatr Phys Ther. 2024 Jan-Mar 01;47(1):43-54. doi: 10.1519/JPT.0000000000000337. Epub 2022 Apr 19.
citation: Guigoz Y, Vellas B. Nutritional Assessment in Older Adults : MNA(R) 25 years of a Screening Tool and a Reference Standard for Care and Research; What Next? J Nutr Health Aging. 2021;25(4):528-583. doi: 10.1007/s12603-021-1601-y.
citation: Campa F, Bongiovanni T, Rossi A, Cerullo G, Casolo A, Martera G, Trecroci A, Moro T, Paoli A. Athletic bioimpedance-based equations underestimate fat free mass components in male elite soccer players: development and validation of new soccer-specific predictive models. J Transl Med. 2023 Dec 15;21(1):912. doi: 10.1186/s12967-023-04795-z.
citation: Magave JA, Bezerra SJS, Matos AP, Pinto ACPN, Pegorari MS, Ohara DG. Peak Expiratory Flow as an Index of Frailty Syndrome in Older Adults: A Cross-Sectional Study. J Nutr Health Aging. 2020;24(9):993-998. doi: 10.1007/s12603-020-1423-3.
citation: Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
citation: Koltowski L, Balsam P, Glowczynska R, Rokicki JK, Peller M, Maksym J, Blicharz L, Maciejewski K, Niedziela M, Opolski G, Grabowski M. Kardia Mobile applicability in clinical practice: A comparison of Kardia Mobile and standard 12-lead electrocardiogram records in 100 consecutive patients of a tertiary cardiovascular care center. Cardiol J. 2021;28(4):543-548. doi: 10.5603/CJ.a2019.0001. Epub 2019 Jan 15.
citation: Fried LP, Cohen AA, Xue QL, Walston J, Bandeen-Roche K, Varadhan R. The physical frailty syndrome as a transition from homeostatic symphony to cacophony. Nat Aging. 2021 Jan;1(1):36-46. doi: 10.1038/s43587-020-00017-z. Epub 2021 Jan 14.
citation: Camera A, Tabetah M, Castaneda V, Kim J, Galsinh AS, Haro-Vinueza A, Salinas I, Seylani A, Arif S, Das S, Mori MA, Carano A, de Oliveira LC, Muratani M, Barker R, Zaksas V, Goel C, Dimokidis E, Taylor DM, Jeong J, Overbey E, Meydan C, Porterfield DM, Diaz JE, Caicedo A, Schisler JC, Laiakis EC, Mason CE, Kim MS, Karouia F, Szewczyk NJ, Beheshti A. Aging and putative frailty biomarkers are altered by spaceflight. Sci Rep. 2024 Jun 11;14(1):13098. doi: 10.1038/s41598-024-57948-5.
citation: The Lancet Regional Health-Europe. Securing the future of Europe's ageing population by 2050. Lancet Reg Health Eur. 2023 Dec 1;35:100807. doi: 10.1016/j.lanepe.2023.100807. eCollection 2023 Dec. No abstract available.
citation: Lisko I, Kulmala J, Annetorp M, Ngandu T, Mangialasche F, Kivipelto M. How can dementia and disability be prevented in older adults: where are we today and where are we going? J Intern Med. 2021 Jun;289(6):807-830. doi: 10.1111/joim.13227. Epub 2021 Jan 10.