NCT02300896

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

November 19, 2014

Last Update Submit

September 11, 2017

Conditions

Functional ImpairmentCognitive ImpairmentElderly

Keywords

exercisephysical fitnessgeriatrics

Outcome Measures

Primary Outcomes (2)

  • Changes in functional status after the intervention (Barthel Index)

    Barthel Index

    Baseline (Hospital Admiission), 1 and 3 months later

  • Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)

    Mini Mental State Evaluation, GDS Yesavage, Trail Making Test

    Baseline (Hospital Admiission) and 1 and 3 months later

Secondary Outcomes (4)

  • Quality of life (EuroQol Scale)

    Baseline (Hospital Admission), 1 and 3 months later

  • delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)

    Baseline (Hospital Admission),1 and 3 months later

  • mortality

    Baseline (Hospital Admission), 1 and 3 months later

  • Use of health resources

    Baseline (Hospital Admission), 1 and 3 months later

Study Arms (2)

Intervention

EXPERIMENTAL

Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization

Other: Group-based exercise training during hospitalization

Control

NO INTERVENTION

Usual care including rehabilitation when necessary

Interventions

Group-based exercise training during hospitalizationOTHER

Exercise training. Individual program training 5 days a week during hospitalization

Intervention

Eligibility Criteria

Age74 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario de Navarra. Department of Geriatrics

Pamplona, Navarre, 31008, Spain

Location

Related Publications (8)

  • 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.

    PMID: 33522565DERIVED

  • 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.

    PMID: 33267668DERIVED

  • 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.

    PMID: 33150389DERIVED

  • 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.

    PMID: 33011095DERIVED

  • 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.

    PMID: 32155323DERIVED

  • 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.

    PMID: 31276501DERIVED

  • 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.

    PMID: 30419096DERIVED

  • 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.

    PMID: 26374430DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Nicolas Martínez-Velilla, PhD

    Complejo Hospitalario de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 25, 2014

Study Start

March 1, 2015

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

ES(1)