Functional ImpairmentNCT02300896
Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients
A study testing Group-based exercise training during hospitalization in people with Functional Impairment and Cognitive Impairment, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Read more about this study
- Who is it for?
- Ages 74 years and older
- Conditions the study is for
- Functional Impairment, Cognitive Impairment, Elderly
- What is being tested?
- Group-based exercise training during hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jan 2018
- 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 74 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 75 years and older
- Able to tolerate exercise
- Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
- Able to communicate
- Non-elective admission to hospital
Who cannot join
- Severe dementia (GDS 7)
- Duration of hospitalization <72 hours
- Unwillingness to either complete the study requirements or to be randomized into control or intervention group
- Unstable cardiovascular disease or other unstable medical condition
- Terminal illness
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario de Navarra. Department of Geriatrics
Pamplona, Navarre, 31008
About this study
Official title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.
Read the detailed description
This study is a randomized clinical trial conducted in a Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. Patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the Department of Geriatrics. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 3, 6 and 12 after hospital discharge.
- Conditions
- Functional Impairment, Cognitive Impairment, Elderly
- Being tested
- Group-based exercise training during hospitalization
- Keywords
- exercise, physical fitness, geriatrics
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based exercise training during hospitalizationOther
Exercise training. Individual program training 5 days a week during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization Receives: Other: Group-based exercise training during hospitalization |
| Control | No intervention | Usual care including rehabilitation when necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional status after the intervention (Barthel Index)
Barthel Index
Measured: Baseline (Hospital Admiission), 1 and 3 months later
Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)
Mini Mental State Evaluation, GDS Yesavage, Trail Making Test
Measured: Baseline (Hospital Admiission) and 1 and 3 months later
Secondary outcomes (4)
Quality of life (EuroQol Scale)
EuroQol Scale
Measured: Baseline (Hospital Admission), 1 and 3 months later
delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)
Confusion Assessment Method, Delirium Rating Scale-Revised-98
Measured: Baseline (Hospital Admission),1 and 3 months later
mortality
Days alive since admission to hospital
Measured: Baseline (Hospital Admission), 1 and 3 months later
Use of health resources
New admissions to Hospital, admission to nursing homes, visits to General Practitioner
Measured: Baseline (Hospital Admission), 1 and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2017
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Martínez-Velilla, PhD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300896
- Sponsor's protocol ID
- 23/2014
- Status last verified
- Sep 2017
- First submitted
- 19 Nov 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez-Velilla N, Saez de Asteasu ML, Ramirez-Velez R, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Recovery of the Decline in Activities of Daily Living After Hospitalization Through an Individualized Exercise Program: Secondary Analysis of a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):1519-1523. doi: 10.1093/gerona/glab032.
PubMed 33522565Ramirez-Velez R, Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Handgrip Strength as a Complementary Test for Mobility Limitations Assessment in Acutely Hospitalized Oldest Old. Rejuvenation Res. 2021 Jun;24(3):213-219. doi: 10.1089/rej.2020.2344. Epub 2021 Jan 7.
PubMed 33267668Martinez-Velilla N, Valenzuela PL, Saez de Asteasu ML, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Librero-Lopez J, Gorricho J, Perez FE, Lucia A, Izquierdo M. Effects of a Tailored Exercise Intervention in Acutely Hospitalized Oldest Old Diabetic Adults: An Ancillary Analysis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e899-e906. doi: 10.1210/clinem/dgaa809.
PubMed 33150389Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Izquierdo M. Cognitive Function Improvements Mediate Exercise Intervention Effects on Physical Performance in Acutely Hospitalized Older Adults. J Am Med Dir Assoc. 2021 Apr;22(4):787-791. doi: 10.1016/j.jamda.2020.08.024. Epub 2020 Sep 30.
PubMed 33011095Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Cadore EL, Casas-Herrero A, Galbete A, Izquierdo M. Changes in muscle power after usual care or early structured exercise intervention in acutely hospitalized older adults. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):997-1006. doi: 10.1002/jcsm.12564. Epub 2020 Mar 10.
PubMed 32155323Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Casas-Herrero A, Cadore EL, Galbete A, Izquierdo M. Assessing the impact of physical exercise on cognitive function in older medical patients during acute hospitalization: Secondary analysis of a randomized trial. PLoS Med. 2019 Jul 5;16(7):e1002852. doi: 10.1371/journal.pmed.1002852. eCollection 2019 Jul.
PubMed 31276501Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
PubMed 30419096Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x.
PubMed 26374430
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02300896
- Acronym / sponsor ID
- 23/2014
- Conditions
- Functional Impairment, Cognitive Impairment, Elderly
- Keywords
- exercise, physical fitness, geriatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Nov 2014 (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.
The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.
Detailed description
This study is a randomized clinical trial conducted in a Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. Patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the Department of Geriatrics. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 3, 6 and 12 after hospital discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Group-based exercise training during hospitalizationGroup-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization |
| Control | No intervention | –Usual care including rehabilitation when necessary |
Who may qualify
- Ages
- 74 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 75 years and older
- Able to tolerate exercise
- Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
- Able to communicate
- Non-elective admission to hospital
Key exclusion criteria (5 listed)
- Severe dementia (GDS 7)
- Duration of hospitalization <72 hours
- Unwillingness to either complete the study requirements or to be randomized into control or intervention group
- Unstable cardiovascular disease or other unstable medical condition
- Terminal illness
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 |
|---|---|---|
| Group-based exercise training during hospitalizationExercise training. Individual program training 5 days a week during hospitalization | Other | Intervention |
Primary outcome
Changes in functional status after the intervention (Barthel Index)
Time frame: Baseline (Hospital Admiission), 1 and 3 months later
Barthel Index
Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)
Time frame: Baseline (Hospital Admiission) and 1 and 3 months later
Mini Mental State Evaluation, GDS Yesavage, Trail Making Test
4 secondary outcomes
Quality of life (EuroQol Scale)
Time frame: Baseline (Hospital Admission), 1 and 3 months later
delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)
Time frame: Baseline (Hospital Admission),1 and 3 months later
mortality
Time frame: Baseline (Hospital Admission), 1 and 3 months later
Use of health resources
Time frame: Baseline (Hospital Admission), 1 and 3 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Derived from this study: PubMed 33522565Martinez-Velilla N, Saez de Asteasu ML, Ramirez-Velez R, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Recovery of the Decline in Activities of Daily Living After Hospitalization Through an Individualized Exercise Program: Secondary Analysis of a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):1519-1523. doi: 10.1093/gerona/glab032.
- Derived from this study: PubMed 33267668Ramirez-Velez R, Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Garcia-Hermoso A, Izquierdo M. Handgrip Strength as a Complementary Test for Mobility Limitations Assessment in Acutely Hospitalized Oldest Old. Rejuvenation Res. 2021 Jun;24(3):213-219. doi: 10.1089/rej.2020.2344. Epub 2021 Jan 7.
- Derived from this study: PubMed 33150389Martinez-Velilla N, Valenzuela PL, Saez de Asteasu ML, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Librero-Lopez J, Gorricho J, Perez FE, Lucia A, Izquierdo M. Effects of a Tailored Exercise Intervention in Acutely Hospitalized Oldest Old Diabetic Adults: An Ancillary Analysis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e899-e906. doi: 10.1210/clinem/dgaa809.
- Derived from this study: PubMed 33011095Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Izquierdo M. Cognitive Function Improvements Mediate Exercise Intervention Effects on Physical Performance in Acutely Hospitalized Older Adults. J Am Med Dir Assoc. 2021 Apr;22(4):787-791. doi: 10.1016/j.jamda.2020.08.024. Epub 2020 Sep 30.
- Derived from this study: PubMed 32155323Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Ramirez-Velez R, Garcia-Hermoso A, Cadore EL, Casas-Herrero A, Galbete A, Izquierdo M. Changes in muscle power after usual care or early structured exercise intervention in acutely hospitalized older adults. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):997-1006. doi: 10.1002/jcsm.12564. Epub 2020 Mar 10.
- Derived from this study: PubMed 31276501Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Casas-Herrero A, Cadore EL, Galbete A, Izquierdo M. Assessing the impact of physical exercise on cognitive function in older medical patients during acute hospitalization: Secondary analysis of a randomized trial. PLoS Med. 2019 Jul 5;16(7):e1002852. doi: 10.1371/journal.pmed.1002852. eCollection 2019 Jul.
- Derived from this study: PubMed 30419096Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
- Derived from this study: PubMed 26374430Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x.
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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.
Nicolas Martínez-Velilla, PhD principal investigator
Complejo Hospitalario de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based exercise training during hospitalization in people with Functional Impairment and Cognitive Impairment, run by Fundacion Miguel Servet 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Sep 2017. 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?
Results are not available in the source record.
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?
Changes in functional status after the intervention (Barthel Index) (time frame: Baseline (Hospital Admiission), 1 and 3 months later). The study lists 2 primary outcomes in all. 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 NCT02300896, which also lists 8 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 12 Sep 2017.