Frailty Clinical Trial
— Ros-ItaOfficial title:
Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study
Verified date | July 2022 |
Source | Hospital de la Ribera |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults. The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months. Information will be collected by researchers at baseline, monthly and after study finishes.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2024 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 100 Years |
Eligibility | Inclusion Criteria: - Frailty - Informed consent signature Exclusion Criteria: - Life expectancy less than 6 months - Acute Ischemic coronariopathy event during the last three months - Active cancer treatment (chemoteraphy or radiotherapy) during the last three months - Major surgery during the last six months |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de la Ribera | Alzira, | Kingdom Of Valéncia |
Lead Sponsor | Collaborator |
---|---|
Hospital de la Ribera | University of Valencia |
Spain,
Giné-Garriga M, Roqué-Fíguls M, Coll-Planas L, Sitjà-Rabert M, Salvà A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. Review. Erratum in: Arch Phys Med Rehabil. 2018 Jan;99(1):211-212. — View Citation
Martínez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Sáez de Asteasu ML, Lucia A, Galbete A, García-Baztán A, Alonso-Renedo J, González-Glaría B, Gonzalo-Lázaro M, Apezteguía Iráizoz I, Gutiérrez-Valencia M, Rodríguez-Mañas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869. Erratum in: JAMA Intern Med. 2019 Jan 1;179(1):127. — View Citation
Sanders LMJ, Hortobágyi T, la Bastide-van Gemert S, van der Zee EA, van Heuvelen MJG. Dose-response relationship between exercise and cognitive function in older adults with and without cognitive impairment: A systematic review and meta-analysis. PLoS One. 2019 Jan 10;14(1):e0210036. doi: 10.1371/journal.pone.0210036. eCollection 2019. — View Citation
Tarazona-Santabalbina FJ, Gómez-Cabrera MC, Pérez-Ros P, Martínez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Mañas L, Viña J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Network — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frailty reversion. | Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail | Six months | |
Primary | Intrinsic capacity | ICOPE questionnaire score | Six months | |
Primary | Quality of life objective and subjective | EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10. | Six months | |
Primary | Polypharmacy | Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs. | Six months | |
Primary | Cognitive state | Pfeiffer questionnaire | Six months | |
Primary | Depression | Yesavage's Geriatrics Depression Scale (15 items) | Six months | |
Primary | Nutrition state | Mini Nutritional Assessment Short Form. Score 0 to 14. | Six months | |
Primary | Falls | Number of falls during follow-up period | Six months | |
Primary | Sarcopenia | European Working Group on Sarcopenia in Older People (EWGSOP) criteria | Six months | |
Secondary | Hospital admissions | Number of hospital admissions during follow-up period | Six months | |
Secondary | Visits to General Practitioner (GP) | Number of visits to GP during follow-up period | Six months | |
Secondary | Validation of a shaking measurement tool to asses muscle strength | Gold standard Hand grip measured by dinamometry | six months | |
Secondary | Validation of a gait speed mobile phone tool | Gold standard Gait speed measurement | Six months | |
Secondary | Validation of a pulmonar capacity mobile phone tool | Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC) | six months |
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