Physical Training in Hospitalized Elderly

Functional Impairment Clinical Trial

— AGECAR  

Official title:

Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374893
• Other study ID #: HGUGregorioMaranon
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Functional Impairment

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).