Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01374893
Other study ID # HGUGregorioMaranon
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2011
Est. completion date October 1, 2014

Study information

Verified date July 2018
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Objective: The main objective of this study is to assess whether an inpatient exercise program, beyond other components of interdisciplinary care, could reduce hospital associated disability (HAD) in medical patients aged 75 years and older admitted to an acute care for elders (ACE) unit.

Population: The reference population will be patients aged 75 years and older admitted to the ACE unit from the emergency department. This study will include only patients discharged alive. Exclusion criteria include patients fully dependent at baseline, unable to sign informed consent, unstable medical condition, short stay (<3 days), end stage illness.

Interventions: Patients will be randomly assigned to a control or an intervention group. Participants allocated to the control group will receive usual care in the ACE unit with actions directed to prevent delirium and functional decline. The intervention group, in addition to the usual care, will receive an exercise program. Briefly, this program consisted of strengthening of lower limbs muscles, and walking, daily from Monday to Friday.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date October 1, 2014
Est. primary completion date October 1, 2014
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
The intervention group will perform the multi-session per day training program
Control
Usual care

Locations

Country Name City State
Spain Geriatric Department, Hospital General Universitario Gregorio Marañón Madrid

Sponsors (2)

Lead Sponsor Collaborator
Dr. Jose Antonio SERRA-REXACH Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ability to walk independently Changes in Functional Ambulation Classification (FAC) scale as one of five functional levels of ambulation (range of 0-4). A score of 0 is assigned if the patient cannot walk, one if the patient requires continuous manual contact to support the body, 2 for light or intermittent manual contact to assist balance, 3 for independent but supervised ambulation, and 4 for independent ambulation on level surfaces or stairs. 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).
See also
  Status Clinical Trial Phase
Recruiting NCT05619068 - The Evolution and Prognosis of Moyamoya Disease
Active, not recruiting NCT05416203 - BEAST: A Pilot Trial N/A
Completed NCT03695614 - Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia N/A
Not yet recruiting NCT05490199 - Brief Enhanced Anxiety Sensitivity Treatment N/A
Not yet recruiting NCT06059092 - Evaluation of Three School-based Mental Health Preventive Interventions in France N/A
Completed NCT03145818 - Evaluation of Veteran-Directed Home and Community Based Services
Recruiting NCT03106064 - Independence in Self Care - A Program Focused on Nursing Care N/A
Active, not recruiting NCT02300896 - Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients N/A
Not yet recruiting NCT06404970 - A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings N/A
Enrolling by invitation NCT02674698 - Disseminating a Dashboard for VA Purchased Community Nursing Homes N/A
Recruiting NCT05020587 - Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events Early Phase 1
Completed NCT04795791 - Evaluation of Veteran-Directed Home and Community Based Services
Completed NCT03474380 - Optimizing Function and Independence Through iHI-FIVES N/A