Clinical DeteriorationFIS_PreventionNCT07707310
Multicomponent Exercise to Prevent Hospitalization-Associated Disability
A study testing Behavioral: Exercise in people with Clinical Deterioration, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Deterioration
- What is being tested?
- Behavioral: Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
Who cannot join
- Explicit refusal expressed verbally or refusal to sign the informed consent by the patient/main caregiver/legal guardian or inability to obtain it.
- Life expectancy of less than 3 months or terminal oncological or non -oncological disease.
- Inability to follow up.
- Inability to participate in a multicomponent exercise program.
- Medical contraindication to exercise.
- Major neurocognitive disorder at moderate to severe stage (GDS - Fast Reisberg 5-7).
- Moderate to severe disability (measured by the Barthel Index (BI <60)). Expected hospital stay of less than 6 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Nicolas Martinez-Velilla, +34 848422287, nicolas.martinez.velilla@navarra.es
About this study
Official title: Prevention of Disability in Older Adults: From the Patient to the Molecule - A Randomized Controlled Trial (RCT)
The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance.
Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge.
Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy <3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index <35).
Read the detailed description
General Objective
To determine whether an intervention consisting of a multicomponent physical exercise program based on strength, balance, and aerobic training can prevent hospitalization-associated disability in adults aged 75 years and older admitted for acute medical conditions, while improving functional and cognitive capacity.
Specific Objectives
- To analyze and identify the patient subgroups that derive the greatest benefit from the intervention in order to optimize healthcare resource allocation (e.g., frail patients, patients with cognitive impairment, malnourished patients), and to characterize these subgroups.
- To identify the sociodemographic, clinical, functional, and cognitive characteristics associated with greater responsiveness to the intervention, as well as the type of intervention that provides the greatest benefit.
- To integrate clinical and molecular approaches through the assessment of epigenetic and inflammatory biomarkers, enabling the evaluation of parameters that have not previously been incorporated into studies of this kind.
- Conditions
- Clinical Deterioration
- Being tested
- Behavioral: Exercise
- Keywords
- hospital acquired disability, exercise, function, cognition
- Medical subject headings
- Clinical Deterioration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: ExerciseOther
Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit
| Study group | Role | What they receive |
|---|---|---|
| No exercise during hospitalization | No intervention | Not described |
| Exercise during hospitalization | Experimental | Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit Receives: Other: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Short Performance Physical Battery (SPPB)
Measured: Through study completion, an average of 3 months
Secondary outcomes (14)
Barthel Index
Basic activities of daily living
Measured: Through study completion, an average of 3 months]
Mini-Mental State Examination (MMSE)
Cognition
Measured: Through study completion, an average of 3 months
Trail Making Test A
Complex attention
Measured: Through study completion, an average of 3 months
GDS Yesavage
Depression
Measured: Through study completion, an average of 3 months
EuroQol-5D-3L
Quality of life
Measured: Through study completion, an average of 3 months
Number of medications
Number of medications before and after de intervention
Measured: Through study completion, an average of 3 months
Falls
Number of falls during the study
Measured: Through study completion, an average of 3 months
Mortality
Mortality during the study
Measured: Through study completion, an average of 3 months
Hospital Readmissions
Number of Hospital Readmissions
Measured: Through study completion, an average of 3 months
Hand Grip
Maximum isometric strength
Measured: Through study completion, an average of 3 months
Length of stay
Average length of hospital stay
Measured: Through study completion, an average of 3 months
SATED scale
Changes in sleep quality
Measured: Through study completion, an average of 3 months
Changes in plasma/serum proteomic profiles.
Protein expression profiles will be assessed to identify changes in circulating proteins associated with the intervention and to explore potential biological pathways involved in the observed effects
Measured: Through study completion, an average of 3 months
Changes in DNA methylation profiles and epigenetic age
Buffy coat samples will be used for DNA extraction. Extracted DNA will be hybridized on DNA methylation arrays to assess genome-wide methylation profiles and identify differentially methylated regions/sites associated with the intervention. DNA methylation data will also be used to estimate biological age through established epigenetic clocks, allowing the evaluation of changes in epigenetic age and/or epigenetic age acceleration.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Feb 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DeteriorationStudies 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
- Single group
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Martinez-Velilla, Principal investigator, Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707310
- Sponsor's protocol ID
- FIS_PreventionDisability
- Acronym
- FIS_Prevention
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Disability in Older Adults: From the Patient to the Molecule - A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07707310
- Acronym / sponsor ID
- FIS_Prevention / FIS_PreventionDisability
- Conditions
- Clinical Deterioration
- Keywords
- hospital acquired disability, exercise, function, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Jul 2026 (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 study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance.
Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge.
Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy <3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index <35).
Detailed description
General Objective
To determine whether an intervention consisting of a multicomponent physical exercise program based on strength, balance, and aerobic training can prevent hospitalization-associated disability in adults aged 75 years and older admitted for acute medical conditions, while improving functional and cognitive capacity.
Specific Objectives
- To analyze and identify the patient subgroups that derive the greatest benefit from the intervention in order to optimize healthcare resource allocation (e.g., frail patients, patients with cognitive impairment, malnourished patients), and to characterize these subgroups.
- To identify the sociodemographic, clinical, functional, and cognitive characteristics associated with greater responsiveness to the intervention, as well as the type of intervention that provides the greatest benefit.
- To integrate clinical and molecular approaches through the assessment of epigenetic and inflammatory biomarkers, enabling the evaluation of parameters that have not previously been incorporated into studies of this kind.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| No exercise during hospitalization | No intervention | – |
| Exercise during hospitalization | Experimental | Other: Behavioral: ExerciseMulticomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
Key exclusion criteria (7 listed)
- Explicit refusal expressed verbally or refusal to sign the informed consent by the patient/main caregiver/legal guardian or inability to obtain it.
- Life expectancy of less than 3 months or terminal oncological or non -oncological disease.
- Inability to follow up.
- Inability to participate in a multicomponent exercise program.
- Medical contraindication to exercise.
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 |
|---|---|---|
| Behavioral: ExerciseMulticomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit | Other | Exercise during hospitalization |
Primary outcome
Functional status
Time frame: Through study completion, an average of 3 months
Short Performance Physical Battery (SPPB)
14 secondary outcomes
Barthel Index
Time frame: Through study completion, an average of 3 months]
Mini-Mental State Examination (MMSE)
Time frame: Through study completion, an average of 3 months
Trail Making Test A
Time frame: Through study completion, an average of 3 months
GDS Yesavage
Time frame: Through study completion, an average of 3 months
EuroQol-5D-3L
Time frame: Through study completion, an average of 3 months
Number of medications
Time frame: Through study completion, an average of 3 months
Falls
Time frame: Through study completion, an average of 3 months
Mortality
Time frame: Through study completion, an average of 3 months
Hospital Readmissions
Time frame: Through study completion, an average of 3 months
Hand Grip
Time frame: Through study completion, an average of 3 months
Length of stay
Time frame: Through study completion, an average of 3 months
SATED scale
Time frame: Through study completion, an average of 3 months
Changes in plasma/serum proteomic profiles.
Time frame: Through study completion, an average of 3 months
Changes in DNA methylation profiles and epigenetic age
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
Nicolas Martinez-Velilla principal investigator
Navarrabiomed-Fundación Miguel Servet-Hospital 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 Behavioral: Exercise in people with Clinical Deterioration, 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 1 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Martinez-Velilla (+34 848422287, nicolas.martinez.velilla@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.