Physical Training in Hospitalized Elderly (AGECAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Hospital General Universitario Gregorio Marañon.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01374893
First received: June 9, 2011
Last updated: June 15, 2011
Last verified: May 2011
  Purpose

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 Intervention
Functional Impairment
Behavioral: Exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline (hospital admission) and 3 to 14 days later (i.e. at hospital discharge) ] [ Designated as safety issue: No ]
    This is a test of functional ability especifically designed for all people


Secondary Outcome Measures:
  • Mortality [ Time Frame: 3 months after hospital discharge ] [ Designated as safety issue: No ]
    This outcome that will be assessed by telephone interview three months after discharge


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374893

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

No publications provided by Hospital General Universitario Gregorio Marañon

Additional 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
Study First Received: June 9, 2011
Last Updated: June 15, 2011
Health Authority: Spain: Ministry of Health and Consumption

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

ClinicalTrials.gov processed this record on April 17, 2014