HospitalizedNUTPHYSNCT07067697
Impact of Physical Exercise on Hospitalized Older Adults Malnourished or at Risk, With Oral Nutritional Support
A study testing Physical exercise in people with Hospitalized and Older Adults, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hospitalized, Older Adults, Physical Exercise
- What is being tested?
- Physical exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2025to Jul 2026
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 75 years or above
- Hospitalized in the Acute Unit of the Geriatrics Service at the University Hospital of Navarra
- 4 days or more of expected hospitalization
- Malnourished according to the GLIM criteria or at risk of malnourishment (MUST scale)
- Barthel Index ≥ 60 points
- Capable of tolerating oral intake
Show all 9Show fewer
- Able to walk (with or without assistance)
- Able to understand instructions and communicate
- Consent to participate in the study after being informed of its objectives and who sign the informed consent (the participant or their legal guardian in case of disability).
Who cannot join
- Advanced major neurocognitive disorder (GDS 6 and 7)
- Uncontrolled cardiac arrhythmia, acute pulmonary thromboembolism, acute myocardial infarction, or bone fractures within the last 3 months
- Chronic kidney disease stage 4 or 5
- Safe and effective swallowing only with pudding texture
- Inability to participate in the physical exercise program due to physical limitations
- Participate in another study that may interfere with data interpretation or have participated in another study in six months prior to their entry into the study.
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
University Hospital of Navarra
Pamplona, Navarre, 31008
Nicolás Martínez-Velilla, Doctor, +34 670900434, nicolas.martinez.velilla@navarra.es
About this study
Official title: The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation
The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity.
To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.
Read the detailed description
The main objective of the present study is to evaluate the differences in the impact of an intervention based solely on physical exercise on the functionality of hospitalized older patients, in an Acute Geriatric Unit, who are malnourished or at risk of malnutrition.
As secondary objectives:
- To assess and compare changes in body composition following the intervention during hospitalization.
- To evaluate and compare dietary intake, appetite progression, and food consumption throughout the intervention period.
- To compare in-hospital infectious complications between the two groups.
- To describe and compare changes in nutritional biochemical parameters between groups after the intervention and 30 days post-discharge.
- To study changes in other physical function measures throughout the study period and compare them.
- To describe the presence of molecular markers related to senescence and sarcopenia in patients and compare them between groups at discharge.
- To study and compare changes in participants' cognitive status.
- To evaluate and compare changes in perceived quality of life.
- To assess and compare changes in maximal dynamic strength before and after the intervention.
- To describe and compare hospital stays and 30-day readmission rates of study participants.
- To describe participants' personal satisfaction with the intervention.
- To describe the presence of potential side effects attributed to the intervention during the study period.
- Being tested
- Physical exercise, Usual Care
- Keywords
- hospital-acquired disability, older adults, physical exercise, oral nutritional supplementation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Progressive, supervised multicomponent physical exercise program, including aerobic resistance, strength, and balance training. Strength training for lower limbs (leg press and knee extension) and upper limbs (seated chest press) will be adapted to each individual's functional capacity.
Usual CareOther
- Hospital physiotherapy for preventing nosocomial disability when necessary.
- Hospital diet modifications appropriate to each participant's clinical situation.
- Oral nutritional supplementation aimed at meeting daily nutritional requirements: 30 kcal/kg body weight, 1.5-2 g protein/kg body weight, 25 g daily fiber.
- Approximate free water intake: women 1.5 L/day, men 2 L/day (unless clinically restricted).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants included in this group will perform physical exercise Receives: Other: Physical exercise |
| Control | Active comparator | Participants in this group will receive attention from a physiotherapist if needed. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
SPPB - Short Physical Performance Battery
Measured: Through study completion, an average of 4 days
Secondary outcomes (11)
Anthropometrical Measurements
Bioimpedance: PHASE ANGLE (PhA), Fat-Free Mass (FFM) and Muscle Mass (MM). Conventional and vectorial bioelectrical impedance analysis with a single-frequency bioelectrical impedance analyzer at 50 kHz (BIA 101 RJL, Akern Bioresearch, Florence, Italy)
Measured: Through study completion, an average of 4 days
Dietary intake
Semi-quantitative questionnaire and a daily appetite assessment
Measured: Through study completion, an average of 4 days
Number and type of infectious complications
Measured: Through study completion, an average of 4 days
Nutritional status biomarkers
In blood: proteins, prealbumin, albumin, transferrin, lymphocytes, 25-hydroxyvitamin D, C-reactive protein.
Measured: Through study completion, an average of 4 days, and 30 days post-discharge
Functional status
Barthel Index, Lawton Index
Measured: Through study completion, an average of 4 days, and 30 days post-discharge
Frailty status
Linda Fried's Frailty Scale, from 0 to 5 (0 robust; 1,2 pre-frail; 3 to 5 frail).
Measured: Baseline
Strength of upper and lower limbs
Leg press, chest press, knee extension, and handgrip strength
Measured: Through study completion, an average of 4 days
Cognitive status
Mini-Mental State Examination, 4AT
Measured: Through study completion, an average of 4 days
Affective status
Yesavage's 15-item Geriatric Depression Scale (GDS-15)
Measured: Through study completion, an average of 4 days
Quality of life of participants
EuroQoL-5D-3L
Measured: Through study completion, an average of 4 days
Adverse effects possibly attributed to the intervention
Measured: Through study completion, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start14 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
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 HospitalizedStudies 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
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067697
- Sponsor's protocol ID
- NUTPHYS
- Acronym
- NUTPHYS
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chenhuichen C, Cedeno Veloz BA, Zugasti Murillo A, Martinez-Velilla N. Physical exercise and oral nutritional supplementation on hospitalized malnourished or at-risk older adults: protocol for a randomized controlled trial. Rev Esp Geriatr Gerontol. 2026 Nov 2;61(6):101842. doi: 10.1016/j.regg.2026.101842. Online ahead of print.
PubMed 42971106
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation
- ClinicalTrials.gov ID
- NCT07067697
- Acronym / sponsor ID
- NUTPHYS / NUTPHYS
- Keywords
- hospital-acquired disability, older adults, physical exercise, oral nutritional supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Nestle Health Science
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Jul 2025 (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 aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity.
To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.
Detailed description
The main objective of the present study is to evaluate the differences in the impact of an intervention based solely on physical exercise on the functionality of hospitalized older patients, in an Acute Geriatric Unit, who are malnourished or at risk of malnutrition.
As secondary objectives:
- To assess and compare changes in body composition following the intervention during hospitalization.
- To evaluate and compare dietary intake, appetite progression, and food consumption throughout the intervention period.
- To compare in-hospital infectious complications between the two groups.
- To describe and compare changes in nutritional biochemical parameters between groups after the intervention and 30 days post-discharge.
- To study changes in other physical function measures throughout the study period and compare them.
- To describe the presence of molecular markers related to senescence and sarcopenia in patients and compare them between groups at discharge.
- To study and compare changes in participants' cognitive status.
- To evaluate and compare changes in perceived quality of life.
- To assess and compare changes in maximal dynamic strength before and after the intervention.
- To describe and compare hospital stays and 30-day readmission rates of study participants.
- To describe participants' personal satisfaction with the intervention.
- To describe the presence of potential side effects attributed to the intervention during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physical exerciseParticipants included in this group will perform physical exercise |
| Control | Active comparator | Other: Usual CareParticipants in this group will receive attention from a physiotherapist if needed. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Aged 75 years or above
- Hospitalized in the Acute Unit of the Geriatrics Service at the University Hospital of Navarra
- 4 days or more of expected hospitalization
- Malnourished according to the GLIM criteria or at risk of malnourishment (MUST scale)
- Barthel Index ≥ 60 points
Key exclusion criteria (6 listed)
- Advanced major neurocognitive disorder (GDS 6 and 7)
- Uncontrolled cardiac arrhythmia, acute pulmonary thromboembolism, acute myocardial infarction, or bone fractures within the last 3 months
- Chronic kidney disease stage 4 or 5
- Safe and effective swallowing only with pudding texture
- Inability to participate in the physical exercise program due to physical limitations
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 exerciseProgressive, supervised multicomponent physical exercise program, including aerobic resistance, strength, and balance training. Strength training for lower limbs (leg press and knee extension) and upper limbs (seated chest press) will be adapted to each individual's functional capacity. | Other | Intervention |
| Usual Care* Hospital physiotherapy for preventing nosocomial disability when necessary. * Hospital diet modifications appropriate to each participant's clinical situation. * Oral nutritional supplementation aimed at meeting daily nutritional requirements: 30 kcal/kg body weight, 1.5-2 g protein/kg body weight, 25 g daily fiber. * Approximate free water intake: women 1.5 L/day, men 2 L/day (unless clinically restricted). | Other | Control |
Primary outcome
Function
Time frame: Through study completion, an average of 4 days
SPPB - Short Physical Performance Battery
11 secondary outcomes
Anthropometrical Measurements
Time frame: Through study completion, an average of 4 days
Dietary intake
Time frame: Through study completion, an average of 4 days
Number and type of infectious complications
Time frame: Through study completion, an average of 4 days
Nutritional status biomarkers
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
Functional status
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
Frailty status
Time frame: Baseline
Strength of upper and lower limbs
Time frame: Through study completion, an average of 4 days
Cognitive status
Time frame: Through study completion, an average of 4 days
Affective status
Time frame: Through study completion, an average of 4 days
Quality of life of participants
Time frame: Through study completion, an average of 4 days
Adverse effects possibly attributed to the intervention
Time frame: Through study completion, an average of 4 days
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 24 Sep 2025.
- Derived from this study: PubMed 42971106Chenhuichen C, Cedeno Veloz BA, Zugasti Murillo A, Martinez-Velilla N. Physical exercise and oral nutritional supplementation on hospitalized malnourished or at-risk older adults: protocol for a randomized controlled trial. Rev Esp Geriatr Gerontol. 2026 Nov 2;61(6):101842. doi: 10.1016/j.regg.2026.101842. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
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 exercise in people with Hospitalized and Older Adults, 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 9 inclusion and 6 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 24 Sep 2025. 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 Chenhui Chen, Doctor (+34 664426191, chenhuichen253@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function (time frame: Through study completion, an average of 4 days). 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 NCT07067697, 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 24 Sep 2025.