Clinical trial NCT03604640: Physical Training and Health Education in Hospitalized Elderly
Official title: Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functionally-Impaired Elderly
Keywords: Functional impairment
Hospital associated disability
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-07-27
Enrollment: 260
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Recover basal functional capacity
timeFrame: Three months after discharge
Secondary outcomes:
measure: Recover basal functional status by Barthel Index of Activities of Daily Living
timeFrame: Three months after discharge
measure: Ability to walk independently
timeFrame: Three months after discharge
measure: Physical capacity by the Short Physical Performance Battery (SPPB)
timeFrame: 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.
measure: Physical capacity by the Alusti test
timeFrame: 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.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital general Universitario Gregorio Marañón
Study officials:
affiliation: HGU Gregorio Marañon
name: Jose A Serra, PhD
role: PRINCIPAL_INVESTIGATOR
References: