Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients
Primary Purpose
Functional Impairment, Cognitive Impairment, Elderly
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group-based exercise training during hospitalization
Sponsored by
About this trial
This is an interventional prevention trial for Functional Impairment focused on measuring exercise, physical fitness, geriatrics
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
Sites / Locations
- Complejo Hospitalario de Navarra. Department of Geriatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization
Usual care including rehabilitation when necessary
Outcomes
Primary Outcome Measures
Changes in functional status after the intervention (Barthel Index)
Barthel Index
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
Secondary Outcome Measures
Quality of life (EuroQol Scale)
EuroQol Scale
delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)
Confusion Assessment Method, Delirium Rating Scale-Revised-98
mortality
Days alive since admission to hospital
Use of health resources
New admissions to Hospital, admission to nursing homes, visits to General Practitioner
Full Information
NCT ID
NCT02300896
First Posted
November 19, 2014
Last Updated
September 11, 2017
Sponsor
Fundacion Miguel Servet
1. Study Identification
Unique Protocol Identification Number
NCT02300896
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Impairment, Cognitive Impairment, Elderly
Keywords
exercise, physical fitness, geriatrics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care including rehabilitation when necessary
Intervention Type
Other
Intervention Name(s)
Group-based exercise training during hospitalization
Intervention Description
Exercise training. Individual program training 5 days a week during hospitalization
Primary Outcome Measure Information:
Title
Changes in functional status after the intervention (Barthel Index)
Description
Barthel Index
Time Frame
Baseline (Hospital Admiission), 1 and 3 months later
Title
Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)
Description
Mini Mental State Evaluation, GDS Yesavage, Trail Making Test
Time Frame
Baseline (Hospital Admiission) and 1 and 3 months later
Secondary Outcome Measure Information:
Title
Quality of life (EuroQol Scale)
Description
EuroQol Scale
Time Frame
Baseline (Hospital Admission), 1 and 3 months later
Title
delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)
Description
Confusion Assessment Method, Delirium Rating Scale-Revised-98
Time Frame
Baseline (Hospital Admission),1 and 3 months later
Title
mortality
Description
Days alive since admission to hospital
Time Frame
Baseline (Hospital Admission), 1 and 3 months later
Title
Use of health resources
Description
New admissions to Hospital, admission to nursing homes, visits to General Practitioner
Time Frame
Baseline (Hospital Admission), 1 and 3 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Martínez-Velilla, PhD
Organizational Affiliation
Complejo Hospitalario de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario de Navarra. Department of Geriatrics
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33522565
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.
Results Reference
derived
PubMed Identifier
33267668
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.
Results Reference
derived
PubMed Identifier
33150389
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.
Results Reference
derived
PubMed Identifier
33011095
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.
Results Reference
derived
PubMed Identifier
32155323
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.
Results Reference
derived
PubMed Identifier
31276501
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.
Results Reference
derived
PubMed Identifier
30419096
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. Erratum In: JAMA Intern Med. 2019 Jan 1;179(1):127.
Results Reference
derived
PubMed Identifier
26374430
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.
Results Reference
derived
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Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients
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