Clinical trial NCT02300896: Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients
Official title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Impairment
Cognitive Impairment
Elderly
Keywords: exercise
physical fitness
geriatrics
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 370
Sex: ALL
Minimum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.

Detailed description: This study is a randomized clinical trial conducted in a Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. Patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the Department of Geriatrics. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 3, 6 and 12 after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Age 75 years and older
* Able to tolerate exercise
* Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
* Able to communicate
* Non-elective admission to hospital

Exclusion Criteria:

* Severe dementia (GDS 7)
* Duration of hospitalization \<72 hours
* Unwillingness to either complete the study requirements or to be randomized into control or intervention group
* Unstable cardiovascular disease or other unstable medical condition
* Terminal illness

Primary outcomes:
measure: Changes in functional status after the intervention (Barthel Index)
timeFrame: Baseline (Hospital Admiission), 1 and 3 months later
measure: Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)
timeFrame: Baseline (Hospital Admiission) and 1 and 3 months later
Secondary outcomes:
measure: Quality of life (EuroQol Scale)
timeFrame: Baseline (Hospital Admission), 1 and 3 months later
measure: delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)
timeFrame: Baseline (Hospital Admission),1 and 3 months later
measure: mortality
timeFrame: Baseline (Hospital Admission), 1 and 3 months later
measure: Use of health resources
timeFrame: Baseline (Hospital Admission), 1 and 3 months later
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra. Department of Geriatrics
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Nicolas Martínez-Velilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Velilla N, Saez de Asteasu ML, Ramirez-Velez R, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Recovery of the Decline in Activities of Daily Living After Hospitalization Through an Individualized Exercise Program: Secondary Analysis of a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):1519-1523. doi: 10.1093/gerona/glab032.
citation: Ramirez-Velez R, Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Handgrip Strength as a Complementary Test for Mobility Limitations Assessment in Acutely Hospitalized Oldest Old. Rejuvenation Res. 2021 Jun;24(3):213-219. doi: 10.1089/rej.2020.2344. Epub 2021 Jan 7.
citation: Martinez-Velilla N, Valenzuela PL, Saez de Asteasu ML, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Librero-Lopez J, Gorricho J, Perez FE, Lucia A, Izquierdo M. Effects of a Tailored Exercise Intervention in Acutely Hospitalized Oldest Old Diabetic Adults: An Ancillary Analysis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e899-e906. doi: 10.1210/clinem/dgaa809.
citation: Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Izquierdo M. Cognitive Function Improvements Mediate Exercise Intervention Effects on Physical Performance in Acutely Hospitalized Older Adults. J Am Med Dir Assoc. 2021 Apr;22(4):787-791. doi: 10.1016/j.jamda.2020.08.024. Epub 2020 Sep 30.
citation: Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Cadore EL, Casas-Herrero A, Galbete A, Izquierdo M. Changes in muscle power after usual care or early structured exercise intervention in acutely hospitalized older adults. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):997-1006. doi: 10.1002/jcsm.12564. Epub 2020 Mar 10.
citation: Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Casas-Herrero A, Cadore EL, Galbete A, Izquierdo M. Assessing the impact of physical exercise on cognitive function in older medical patients during acute hospitalization: Secondary analysis of a randomized trial. PLoS Med. 2019 Jul 5;16(7):e1002852. doi: 10.1371/journal.pmed.1002852. eCollection 2019 Jul.
citation: Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas 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.
citation: Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x.