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Clinical Trials/NCT03604640
NCT03604640
Completed
N/A

Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients

Dr. Jose Antonio SERRA-REXACH1 site in 1 country260 target enrollmentMay 3, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Functionally-Impaired Elderly
Sponsor
Dr. Jose Antonio SERRA-REXACH
Enrollment
260
Locations
1
Primary Endpoint
Recover basal functional capacity
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

This research aims to investigate the effect of a training program using gait and muscle training and health education, over the functional capacity of elderly hospitalized patients. The Randomized controlled trial with patients hospitalized in the Acute Care Unit of the Geriatric Department. Participants aged 75 years or older admitted for a short hospital stay will be randomly assigned in a four-week block, to either usual care (control) group or an intervention (training group). Participants allocated in the control group will receive standard hospital care. Participants allocated in the intervention group will perform during hospitalization, training program (30 minutes per session, two sessions per day, lower limb strength training, balance training, walking and inspiratory muscle training) and also health education. Health education consists of several informational activities. Each activity session will teach the patient and caregiver how to perform the exercises to ensure they will continue to be performed at home and before discharge the entire session will be devoted to reviewing the entire program. The type, frequency and progression of the exercises to be carried out will be reviewed; they will be explained how to do them at home and given personalized written instructions with illustrations of the exercises. Also, after one month and two months of discharge, the professional with whom they have completed the training will call them to insist on the completion of the program or to clarify any doubts that may exist.

Registry
clinicaltrials.gov
Start Date
May 3, 2018
End Date
June 30, 2022
Last Updated
3 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

Head Of Geriatry Department

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Recover basal functional capacity

Time Frame: Three months after discharge

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(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.)
  • Recover basal functional status by Barthel Index of Activities of Daily Living(Three months after discharge)

Study Sites (1)

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