Functionally-Impaired ElderlyNCT03604640
Physical Training and Health Education in Hospitalized Elderly
A study testing Physical Training in people with Functionally-Impaired Elderly, run by Dr. Jose Antonio SERRA-REXACH at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Functionally-Impaired Elderly
- What is being tested?
- Physical Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients
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.
Read the 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.
- Conditions
- Functionally-Impaired Elderly
- Being tested
- Physical Training
- Keywords
- Functional impairment, Hospital associated disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TrainingOther
Physical exercise program and health education
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | Not described |
| Physical and educational program | Experimental | Not described Receives: Other: Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recover basal functional capacity
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.
Measured: Three months after discharge
Secondary outcomes (4)
Recover basal functional status by Barthel Index of Activities of Daily Living
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.
Measured: Three months after discharge
Ability to walk independently
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.
Measured: Three months after discharge
Physical capacity by the Short Physical Performance Battery (SPPB)
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start3 May 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functionally-Impaired ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Jose Antonio SERRA-REXACH
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Dr. Jose Antonio SERRA-REXACH, Hospital General Universitario Gregorio Marañon
- Investigators
- Jose A Serra, PhD, Principal investigator, HGU Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604640
- Sponsor's protocol ID
- AGECAR PLUS
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2018
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38329757
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients
- ClinicalTrials.gov ID
- NCT03604640
- Acronym / sponsor ID
- AGECAR PLUS
- Conditions
- Functionally-Impaired Elderly
- Keywords
- Functional impairment, Hospital associated disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Dr. Jose Antonio SERRA-REXACHUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 3 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | – |
| Physical and educational program | Experimental | Other: Physical Training |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TrainingPhysical exercise program and health education | Other | Physical and educational program |
Primary outcome
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.
4 secondary outcomes
Recover basal functional status by Barthel Index of Activities of Daily Living
Time frame: Three months after discharge
Ability to walk independently
Time frame: Three months after discharge
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 38329757Rodriguez-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Serra, PhD principal investigator
HGU Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training in people with Functionally-Impaired Elderly, run by Dr. Jose Antonio SERRA-REXACH at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recover basal functional capacity (time frame: Three months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.