NCT01374893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

June 9, 2011

Last Update Submit

July 13, 2018

Conditions

Functional Impairment

Keywords

Function, hospitalization, elderly

Outcome Measures

Primary Outcomes (1)

  • Recover basal functional capacity

    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.

    During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).

Secondary Outcomes (1)

  • Ability to walk independently

    During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).

Study Arms (2)

Exercise

ACTIVE COMPARATOR
Behavioral: Exercise

Control group

PLACEBO COMPARATOR

Usual care

Behavioral: Control

Interventions

ExerciseBEHAVIORAL

The intervention group will perform the multi-session per day training program

Exercise
ControlBEHAVIORAL

Usual care

Control group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department, Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (2)

  • 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.

    PMID: 31974063DERIVED

  • 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.

    PMID: 22682063DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jose A Serra, PhD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD, head of the Geriatrics Department

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 16, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

ES(1)