Physical Training and Health Education in Hospitalized Elderly

NCT ID: NCT03604640

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Functionally-Impaired Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Physical and educational program

Group Type EXPERIMENTAL

Physical Training

Intervention Type OTHER

Physical exercise program and health education

Interventions

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Physical Training

Physical exercise program and health education

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Dr. Jose Antonio SERRA-REXACH

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jose Antonio SERRA-REXACH

Head Of Geriatry Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose A Serra, PhD

Role: PRINCIPAL_INVESTIGATOR

HGU Gregorio Marañon

Locations

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Hospital general Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Spain

References

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Rodriguez-Lopez C, Mayordomo-Cava J, Zarralanga-Lasobras T, Romero-Estarlich V, Vidan MT, Ortiz-Alonso J, Valenzuela PL, Rodriguez-Romo G, Lucia A, Serra-Rexach JA. Exercise Intervention and Hospital-Associated Disability: A Nonrandomized Controlled Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2355103. doi: 10.1001/jamanetworkopen.2023.55103.

Reference Type DERIVED
PMID: 38329757 (View on PubMed)

Other Identifiers

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AGECAR PLUS

Identifier Type: -

Identifier Source: org_study_id

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