Physical Training in Hospitalized Elderly

Not Applicable

Completed

• Conditions: Functional Impairment
• Interventions: Behavioral: Exercise; Behavioral: Control

• Registration Number: NCT01374893
• Lead Sponsor: Dr. Jose Antonio SERRA-REXACH

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2011-09-01
• Primary Completion: 2014-10-01
• Study Completion: 2014-10-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	-
Control group	Control	Usual care

Primary Outcome Measures

Name	Time	Method
Recover basal functional capacity	During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).	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.

Secondary Outcome Measures

Name	Time	Method
Ability to walk independently	During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).	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.

Trial Locations

Locations (1)

Geriatric Department, Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain