- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374893
Physical Training in Hospitalized Elderly (AGECAR)
Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: The main objective of this study is to assess whether an inpatient exercise program, beyond other components of interdisciplinary care, could reduce hospital associated disability (HAD) in medical patients aged 75 years and older admitted to an acute care for elders (ACE) unit.
Population: The reference population will be patients aged 75 years and older admitted to the ACE unit from the emergency department. This study will include only patients discharged alive. Exclusion criteria include patients fully dependent at baseline, unable to sign informed consent, unstable medical condition, short stay (<3 days), end stage illness.
Interventions: Patients will be randomly assigned to a control or an intervention group. Participants allocated to the control group will receive usual care in the ACE unit with actions directed to prevent delirium and functional decline. The intervention group, in addition to the usual care, will receive an exercise program. Briefly, this program consisted of strengthening of lower limbs muscles, and walking, daily from Monday to Friday.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28007
- Geriatric Department, Hospital General Universitario Gregorio Marañón
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants will include approximately 150 elderly people aged 75 years or older recruited from patients admitted into the Geriatrics Department of the Hospital General Universitario Gregorio Marañón (Madrid, Spain).
- Able to ambulate, with or without personal/technical assistance.
- Able to communicate.
- Informed consent: Must be capable and willing to provide consent.
Exclusion Criteria:
- Duration of hospitalization < 72 hours
- Any factor precluding performance of the physical training program or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
- Terminal illness.
- Myocardial infarction in the past 3 months.
- Not capable of ambulation.
- Unstable cardiovascular disease or other medical condition.
- Upper or lower extremity fracture in the past 3 months.
- Severe dementia.
- Unwillingness to either complete the study requirements or to be randomised into control or intervention group.
- Presence of neuromuscular disease or drugs affecting neuromuscular function.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise
|
The intervention group will perform the multi-session per day training program
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Placebo Comparator: Control group
Usual care
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Usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recover basal functional capacity
Time Frame: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
|
Changes in the number of Activities of daily living (ADLs) that the patients could perform independently.
The six basic ADLs include: bathing, dressing, toileting, transferring, continence, and eating.
For each ADL, a score of 0 is assigned for dependence and 1 for independence.
A summary scale is constructed by summing the individual ADLs (range of 0-6).
Recovery is defined as performance that is at least as good at discharge or 3-months postdischarge as it was at baseline.
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During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to walk independently
Time Frame: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
|
Changes in Functional Ambulation Classification (FAC) scale as one of five functional levels of ambulation (range of 0-4).
A score of 0 is assigned if the patient cannot walk, one if the patient requires continuous manual contact to support the body, 2 for light or intermittent manual contact to assist balance, 3 for independent but supervised ambulation, and 4 for independent ambulation on level surfaces or stairs.
Recovery is defined as performance that is at least as good at discharge or 3-months postdischarge as it was at baseline.
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During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose A Serra, PhD, Hospital General Universitario Gregorio Marañón
Publications and helpful links
General Publications
- Ortiz-Alonso J, Bustamante-Ara N, Valenzuela PL, Vidan-Astiz M, Rodriguez-Romo G, Mayordomo-Cava J, Javier-Gonzalez M, Hidalgo-Gamarra M, Lopez-Tatis M, Valades-Malagon MI, Santos-Lozano A, Lucia A, Serra-Rexach JA. Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Apr;21(4):531-537.e1. doi: 10.1016/j.jamda.2019.11.027. Epub 2020 Jan 20.
- Fleck SJ, Bustamante-Ara N, Ortiz J, Vidan MT, Lucia A, Serra-Rexach JA. Activity in GEriatric acute CARe (AGECAR): rationale, design and methods. BMC Geriatr. 2012 Jun 9;12:28. doi: 10.1186/1471-2318-12-28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HGUGregorioMaranon
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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