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

June 9, 2011
June 15, 2011
September 2011
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01374893 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Physical Training in Hospitalized Elderly
Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Functional Impairment
  • Behavioral: Exercise
    The intervention group will perform the multi-session per day training program
  • Behavioral: Control
    Usual care
  • Active Comparator: Exercise
    Intervention: Behavioral: Exercise
  • Placebo Comparator: Control group
    Usual care
    Intervention: Behavioral: Control
Fleck SJ, Bustamante-Ara N, Ortiz J, Vidán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
December 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
75 Years and older
No
Spain
 
NCT01374893
HGUGregorioMaranon
No
Hospital General Universitario Gregorio Marañon, Geriatric Department
Hospital General Universitario Gregorio Marañon
Not Provided
Principal Investigator: Jose A Serra, PhD Hospital General Universitario Gregorio Marañón
Hospital General Universitario Gregorio Marañon
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP