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Clinical Trials/NCT01374893
NCT01374893
Completed
Not Applicable

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

Dr. Jose Antonio SERRA-REXACH1 site in 1 country260 target enrollmentSeptember 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Impairment
Sponsor
Dr. Jose Antonio SERRA-REXACH
Enrollment
260
Locations
1
Primary Endpoint
Recover basal functional capacity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2011
End Date
October 1, 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Jose Antonio SERRA-REXACH
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Jose Antonio SERRA-REXACH

MD PhD, head of the Geriatrics Department

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Recover basal functional capacity

Time Frame: 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 Outcomes

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

Study Sites (1)

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