Functional ImpairmentAGECARNCT01374893
Physical Training in Hospitalized Elderly
A study testing Exercise in people with Functional Impairment, run by Dr. Jose Antonio SERRA-REXACH at 1 site in Spain.
Trial summary
Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk 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
- Functional Impairment
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2011to 1 Oct 2014
- 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 approximately 150 elderly 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 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.
- Myocardial infarction in the past 3 months.
- Not capable of ambulation.
- Unstable cardiovascular disease or other medical condition.
Show all 10Show fewer
- Upper or lower extremity fracture in the past 3 months.
- Severe dementia.
- Unwillingness to either complete the study requirements or to be randomised into control or intervention group.
- Presence of neuromuscular disease or drugs affecting neuromuscular function.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Geriatric Department, Hospital General Universitario Gregorio Marañón
Madrid, 28007
About this study
Official title: Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients
Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older.
Read the detailed description
Objective: The main objective of this study is to assess whether an inpatient exercise program, beyond other components of interdisciplinary care, could reduce hospital associated disability (HAD) in medical patients aged 75 years and older admitted to an acute care for elders (ACE) unit.
Population: The reference population will be patients aged 75 years and older admitted to the ACE unit from the emergency department. This study will include only patients discharged alive. Exclusion criteria include patients fully dependent at baseline, unable to sign informed consent, unstable medical condition, short stay (<3 days), end stage illness.
Interventions: Patients will be randomly assigned to a control or an intervention group. Participants allocated to the control group will receive usual care in the ACE unit with actions directed to prevent delirium and functional decline. The intervention group, in addition to the usual care, will receive an exercise program. Briefly, this program consisted of strengthening of lower limbs muscles, and walking, daily from Monday to Friday.
- Conditions
- Functional Impairment
- Being tested
- Exercise, Control
- Keywords
- Function, hospitalization, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The intervention group will perform the multi-session per day training program
ControlBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| Control group | Placebo comparator | Usual care Receives: Behavioral: Control |
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: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
Secondary outcomes (1)
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: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study start1 Sep 2011
- Primary completion1 Oct 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional ImpairmentStudies 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
- Single blind
- Who is masked
- Participant
- 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, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374893
- Sponsor's protocol ID
- HGUGregorioMaranon
- Acronym
- AGECAR
- Status last verified
- Jul 2018
- First submitted
- 9 Jun 2011
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ortiz-Alonso J, Bustamante-Ara N, Valenzuela PL, Vidan-Astiz M, Rodriguez-Romo G, Mayordomo-Cava J, Javier-Gonzalez M, Hidalgo-Gamarra M, Lopez-Tatis M, Valades-Malagon MI, Santos-Lozano A, Lucia A, Serra-Rexach JA. Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Apr;21(4):531-537.e1. doi: 10.1016/j.jamda.2019.11.027. Epub 2020 Jan 20.
PubMed 31974063Fleck SJ, Bustamante-Ara N, Ortiz J, Vidan MT, Lucia A, Serra-Rexach JA. Activity in GEriatric acute CARe (AGECAR): rationale, design and methods. BMC Geriatr. 2012 Jun 9;12:28. doi: 10.1186/1471-2318-12-28.
PubMed 22682063
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intrahospital Exercise Program in Functional Capacity of Old Inpatients
- ClinicalTrials.gov ID
- NCT01374893
- Acronym / sponsor ID
- AGECAR / HGUGregorioMaranon
- Conditions
- Functional Impairment
- Keywords
- Function, hospitalization, elderly
- 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
- 1 Sep 2011 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 16 Jun 2011 (estimated)
- 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.
Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older.
Detailed description
Objective: The main objective of this study is to assess whether an inpatient exercise program, beyond other components of interdisciplinary care, could reduce hospital associated disability (HAD) in medical patients aged 75 years and older admitted to an acute care for elders (ACE) unit.
Population: The reference population will be patients aged 75 years and older admitted to the ACE unit from the emergency department. This study will include only patients discharged alive. Exclusion criteria include patients fully dependent at baseline, unable to sign informed consent, unstable medical condition, short stay (<3 days), end stage illness.
Interventions: Patients will be randomly assigned to a control or an intervention group. Participants allocated to the control group will receive usual care in the ACE unit with actions directed to prevent delirium and functional decline. The intervention group, in addition to the usual care, will receive an exercise program. Briefly, this program consisted of strengthening of lower limbs muscles, and walking, daily from Monday to Friday.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise |
| Control group | Placebo comparator | Behavioral: ControlUsual care |
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 approximately 150 elderly 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 (10 listed)
- Duration of hospitalization < 72 hours
- Any factor 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.
- Myocardial infarction in the past 3 months.
- Not capable of ambulation.
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 |
|---|---|---|
| ExerciseThe intervention group will perform the multi-session per day training program | Behavioural | Exercise |
| ControlUsual care | Behavioural | Control group |
Primary outcome
Recover basal functional capacity
Time frame: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
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.
1 secondary outcome
Ability to walk independently
Time frame: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).
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 Jul 2018.
- Derived from this study: PubMed 31974063Ortiz-Alonso J, Bustamante-Ara N, Valenzuela PL, Vidan-Astiz M, Rodriguez-Romo G, Mayordomo-Cava J, Javier-Gonzalez M, Hidalgo-Gamarra M, Lopez-Tatis M, Valades-Malagon MI, Santos-Lozano A, Lucia A, Serra-Rexach JA. Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Apr;21(4):531-537.e1. doi: 10.1016/j.jamda.2019.11.027. Epub 2020 Jan 20.
- Derived from this study: PubMed 22682063Fleck SJ, Bustamante-Ara N, Ortiz J, Vidan MT, Lucia A, Serra-Rexach JA. Activity in GEriatric acute CARe (AGECAR): rationale, design and methods. BMC Geriatr. 2012 Jun 9;12:28. doi: 10.1186/1471-2318-12-28.
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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
Hospital General Universitario 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 Exercise in people with Functional Impairment, 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 10 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 Jul 2018. 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. Some participants in this study may receive a placebo. 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: During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).). 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 NCT01374893, which also lists 2 linked publications.
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 Jul 2018.