Physical Training and Health Education in Hospitalized Elderly

• ClinicalTrials.gov Identifier: NCT03604640
• Recruitment Status: Completed
• First Posted: July 27, 2018
• Last Update Posted: August 17, 2022
• Sponsor: Dr. Jose Antonio SERRA-REXACH
• Collaborator: Instituto de Salud Carlos III
• Information provided by (Responsible Party): Dr. Jose Antonio SERRA-REXACH, Hospital General Universitario Gregorio Marañon

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Functionally-Impaired Elderly	Other: Physical Training	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients
• Actual Study Start Date: May 3, 2018
• Actual Primary Completion Date: June 30, 2022
• Actual Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: standard care
Experimental: Physical and educational program	Other: Physical Training; Physical exercise program and health education

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Recover basal functional status by Barthel Index of Activities of Daily Living [ Time Frame: Three months after discharge ]
   Change in functional status as measured by other scale of physical function: Barthel Index. This index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL). Including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. Low scores on individual items highlight areas of need. Recovery is defined as performance that is at least as good at discharge or 3-months postdischarge as it was at baseline.
2. Ability to walk independently [ Time Frame: Three months after discharge ]
   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.
3. Physical capacity by the Short Physical Performance Battery (SPPB) [ Time Frame: 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. ]
   Changes in functional status as measured by the Short Physical Performance Battery (SPPB). SPPB is measured at admission and discharge. Consists of 3 components: standing balance, gait speed, and repeated chair rise. Balance includes standing with feet side-by-side, semi-tandem, and tandem stance. Gait speed scores reflected the time needed to walk 4 m. Repeated chair rise is scored based on time to complete 5 chair rises. Each SPPB component is scored from 0 to 4, and the total sore ranged was 0-12 with higher scores indicating better function. Recovery is defined as performance that is at least as good at discharge as it was at baseline.
4. Physical capacity by the Alusti test [ Time Frame: 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. ]
   Changes in functional status as measured by the by the Alusti test. The Alusti test is built in its two versions, complete and abbreviated with below variables: 1) Passive joint mobility 2) Active muscle mobility 3) Transfer from decubitus-supine to seat 4) Sitting trunk 5) Transfer from sitting to standing 6) Standing 7) Walk 8) Operating range 9) Tandem with closed eyes 10) Monopodal support with closed eyes. Each of the variables has a score ranging from 0 to 2, 5, 7, 10 and 25 thresholds. The maximum score that can be obtained in the full Alusti test is 100 points and in the short version of 50: they correspond, respectively, to a situation of excellent/preserved mobility. The minimum score for both versions is 0 points, which would correspond to a total dependency situation. Recovery is defined as performance that is at least as good at discharge as it was at baseline.

Eligibility Criteria

• Ages Eligible for Study: 75 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Hospital general Universitario Gregorio Marañón

Madrid, Spain, 28007

Sponsors and Collaborators

Dr. Jose Antonio SERRA-REXACH

Instituto de Salud Carlos III

Investigators

• Principal Investigator: Jose A Serra, PhD; HGU Gregorio Marañon

More Information

• Responsible Party: Dr. Jose Antonio SERRA-REXACH, Head Of Geriatry Department, Hospital General Universitario Gregorio Marañon
• ClinicalTrials.gov Identifier: NCT03604640
• Other Study ID Numbers: AGECAR PLUS
• First Posted: July 27, 2018
• Last Update Posted: August 17, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Jose Antonio SERRA-REXACH, Hospital General Universitario Gregorio Marañon:

Functional impairment; Hospital associated disability