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Physical Training in Hospitalized Elderly (AGECAR)

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ClinicalTrials.gov Identifier: NCT01374893
Recruitment Status : Unknown
Verified May 2011 by Hospital General Universitario Gregorio Marañon.
Recruitment status was:  Not yet recruiting
First Posted : June 16, 2011
Last Update Posted : June 16, 2011
Information provided by:
Hospital General Universitario Gregorio Marañon

Brief Summary:

Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older.

Methods Patients aged 75 years or older admitted for a short hospital stay (≤14 days) will be randomly assigned to either a usual care (control) group or an intervention (training) group. Participants allocated in the usual care group will receive normal hospital care and participants allocated in the intervention group will perform multiple sessions per day of lower limb strength training (standing from a seated position) and walking (10 min bouts) while hospitalized. The Primary outcome to be assessed pre and post of the hospital stay will be functional capacity, using the Short Physical Performance Battery (SPPB), and time to walk 10 meters. Besides length of hospitalization, the secondary outcomes that will also be assessed at hospital admission and discharge will be pulmonary ventilation (forced expiratory volume in one second, FEV1) and peripheral oxygen saturation. The secondary outcomes that will be assessed by telephone interview three months after discharge will be mortality, number of falls since discharge, and ability to cope with activities of daily living (ADLs, using the Katz ADL score and Barthel ADL index).

Results Results will help to better understand the potential of regular physical activity during a short hospital stay for improving functional capacity in old patients.

Conclusions The increase in life expectancy has resulted in a large segment of the population being over 75 years of age and an increase in hospitalization of this same age group. This calls attention to health care systems and public health policymakers to focus on promoting methods to improve functional capacity of this population.

Condition or disease Intervention/treatment
Functional Impairment Behavioral: Exercise Behavioral: Control

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients
Study Start Date : September 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Exercise Behavioral: Exercise
The intervention group will perform the multi-session per day training program
Placebo Comparator: Control group
Usual care
Behavioral: Control
Usual care

Primary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Baseline (hospital admission) and 3 to 14 days later (i.e. at hospital discharge) ]
    This is a test of functional ability especifically designed for all people

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 3 months after hospital discharge ]
    This outcome that will be assessed by telephone interview three months after discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 hospitalizion < 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374893

Geriatric Department, Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Principal Investigator: Jose A Serra, PhD Hospital General Universitario Gregorio Marañón

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital General Universitario Gregorio Marañon, Geriatric Department
ClinicalTrials.gov Identifier: NCT01374893     History of Changes
Other Study ID Numbers: HGUGregorioMaranon
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: May 2011

Keywords provided by Hospital General Universitario Gregorio Marañon:
Function, hospitalization, elderly