NCT03604640

Brief Summary

The Activity in GEriatric acute CARe (AGECAR) Plus Health Education is a randomized control trial to assess the effectiveness of an intrahospital exercise and health education 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 May 2018

Longer than P75 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

Study Start

First participant enrolled

May 3, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

4.2 years

First QC Date

June 28, 2018

Last Update Submit

August 16, 2022

Conditions

Functionally-Impaired Elderly

Keywords

Functional impairmentHospital associated disability

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.

    Three months after discharge

Secondary Outcomes (4)

  • Recover basal functional status by Barthel Index of Activities of Daily Living

    Three months after discharge

  • Ability to walk independently

    Three months after discharge

  • Physical capacity by the Short Physical Performance Battery (SPPB)

    Measurements are taken on the day of admission to the study and the day of discharge from the hospital, an average of 6 days of hospital stay.

  • Physical capacity by the Alusti test

    Measurements are taken on the day of admission to the study and the day of discharge from the hospital, an average of 6 days of hospital stay.

Study Arms (2)

standard care

NO INTERVENTION

Physical and educational program

EXPERIMENTAL
Other: Physical Training

Interventions

Physical TrainingOTHER

Physical exercise program and health education

Physical and educational program

Eligibility Criteria

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

You may qualify if:

  • Participants will include 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 is 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.
  • Not capable of ambulation.
  • Unstable cardiovascular disease or other medical condition.
  • Severe dementia.
  • Unwillingness to either complete the study requirements or to be randomized into control or intervention group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital general Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (1)

  • Rodriguez-Lopez C, Mayordomo-Cava J, Zarralanga-Lasobras T, Romero-Estarlich V, Vidan MT, Ortiz-Alonso J, Valenzuela PL, Rodriguez-Romo G, Lucia A, Serra-Rexach JA. Exercise Intervention and Hospital-Associated Disability: A Nonrandomized Controlled Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2355103. doi: 10.1001/jamanetworkopen.2023.55103.

    PMID: 38329757DERIVED

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jose A Serra, PhD

    HGU Gregorio Marañon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Of Geriatry Department

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 27, 2018

Study Start

May 3, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)