Frail Elderly People HospitalizedNCT07429630
Predictors of Physical Improvement in Frail Hospitalized Elders After Nutrition and Exercise
A study testing Combined ONS and Resistance Training Program in people with Frail Elderly People Hospitalized, run by Zhejiang Hospital at 1 site in China.
Trial summary
This study aims to evaluate whether a 12-week program combining oral nutritional supplements (ONS) with resistance exercises can improve nutritional status, muscle strength, and physical mobility in hospitalized older adults with frailty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly People Hospitalized
- What is being tested?
- Combined ONS and Resistance Training Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 31 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age≥65 years
- Ability to understand and communicate in Chinese
- Sufficient hearing and vision to complete assessments
- Ability to walk independently or with assistive devices
Who cannot join
- Acute cardiovascular or cerebrovascular diseases
- Terminal illnesses
- Severe cognitive impairment (determined by the ward's doctor and physiotherapists).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Analysis of a Frailty Management Program: Identifying Characteristics Associated With Improved Physical Performance Following a Combined Nutrition and Exercise Intervention in Hospitalized Frail Older Adults
This study aims to evaluate whether a 12-week program combining oral nutritional supplements (ONS) with resistance exercises can improve nutritional status, muscle strength, and physical mobility in hospitalized older adults with frailty. The investigators will enroll about 120 frail older inpatients in a single-group design. All participants will receive 90 grams of ONS daily and undergo supervised resistance training five times per week for 12 weeks. Nutrition, physical function, and frailty levels will be assessed before and after the intervention. Baseline characteristics will be examined as potential predictors of intervention response.
- Conditions
- Frail Elderly People Hospitalized
- Being tested
- Combined ONS and Resistance Training Program
- Keywords
- frail older adults, oral nutritional supplementation, resistance exercise, nutrition, physical function status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ONS and Resistance Training ProgramCombination product
Standardized Combined Intervention (Nutrition + Exercise):
A 12-week integrated protocol for all participants. Oral Nutritional Supplement (ONS): Daily intake of 90g whole-protein enteral nutrition powder (450 kcal, 18g protein), dissolved in water and administered in two divided doses. This provides an estimated 30% increase in daily caloric intake.
Supervised Resistance Training: Performed 5 times/week using Thera-Band resistance bands. Each 30-minute session includes warm-up, 6 standardized exercises (e.g., front raise, squat, leg abduction) targeting major muscle groups (2-3 sets of 8-12 repetitions each), and cool-down. Exercise intensity and adherence are monitored and progressed biweekly by trained staff.
Note: This condensed version retains all critical components (dose, frequency, duration, standardization, supervision, and key exercise descriptions) for protocol replication, within a concise format suitable for study registries or summary documents.
| Study group | Role | What they receive |
|---|---|---|
| ONS & Resistance Training Group | Experimental | Not described Receives: Combination Product: Combined ONS and Resistance Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fried frailty phenotype (FP) score
Assessed using the Fried Frailty Phenotype (FP) criteria, which includes five components: (1) unintentional weight loss, (2) weakness (grip strength), (3) poor endurance and energy (self-reported exhaustion via CES-D scale), (4) slowness (walking speed), and (5) low physical activity level (MLTA questionnaire). Frailty is defined as meeting three or more criteria. The Fried Frailty Phenotype (FP) score ranges from 0 to 5, with higher scores indicating a greater severity of frailty.
Measured: Baseline; At 12 weeks post-intervention
short physical performance battery (SPPB) score
Comprises three components: balance tests (side-by-side, semi-tandem, and tandem stands), 4-meter walk speed test, and five times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12. The Short Physical Performance Battery (SPPB) score ranges from 0 to 12 and higher scores reflect better lower extremity function.
Measured: Baseline; At 12 weeks post-intervention
Secondary outcomes (9)
mini nutritional assessment-short form(MNA-SF) score
Assessed using the Mini Nutritional Assessment-Short Form. This 6-item tool screens for malnutrition risk by evaluating weight loss, food intake, mobility, psychological stress, body mass index, and disease. Total scores range from 0 to 14, with scores ≤7 indicating malnutrition, 8-11 indicating at risk of malnutrition, and ≥12 indicating normal nutritional status. The Mini Nutritional Assessment-Short Form (MNA-SF) score ranges from 0 to 14, with higher scores indicating better nutritional status.
Measured: Baseline; At 12 weeks post-intervention
body mass index (BMI)
Calculated from measured height (meters) and weight (kilograms) using the formula: weight (kg) / [height (m)]2. Unit: kg/m2.
Measured: Baseline; At 12 weeks post-intervention
activities of daily living (ADL) score
Assessed using the Barthel Index. This scale evaluates ten activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair/bed transfer, ambulation, and stair climbing. The Activities of Daily Living (ADL) scale based on the Barthel Index score ranges from 0 to 100, with higher scores indicate greater independence.
Measured: Baseline; At 12 weeks post-intervention
instrumental activities of daily living (IADL) score
This scale evaluates evaluates eight domains of function: ability to use a telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. The total score ranges from 0 (low function, dependent) to 8 (high function, independent) . A higher score on the IADL scale indicates a greater level of independence in performing these instrumental activities of daily living.
Measured: Baseline; At 12 weeks post-intervention
performance-oriented mobility assessment (POMA) score
Assessed using the Tinetti Balance and Gait Evaluation. The scale consists of a balance section (9 items, max 16 points) and a gait section (7 items, max 12 points). Total scores range from 0 to 28, with higher scores indicating better balance and gait, and lower fall risk.
Measured: Baseline; At 12 weeks post-intervention
grip strength
Measured using a handheld electronic dynamometer. The participant is seated or standing with the elbow flexed at 90°, forearm and wrist in a neutral position. Maximum force is applied with the dominant hand. The best of two attempts is recorded. Unit: kilograms (kg).
Measured: Baseline; At 12 weeks post-intervention
serum level of transferrin (TFN)
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Measured: Baseline; At 12 weeks post-intervention
serum level of prealbumin (PA)
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Measured: Baseline; At 12 weeks post-intervention
serum level of albumin (ALB)
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Measured: Baseline; At 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start21 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly People 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective, pre-post intervention study. All enrolled frail older inpatients will receive a standardized 12-week combined intervention consisting of daily oral nutritional supplements and supervised resistance training. The primary analysis will compare outcomes (e.g., physical function, nutritional status) between baseline and post-intervention assessments. Additionally, an exploratory responder analysis is planned to identify baseline predictors of functional improvement based on achieving the Minimal Clinically Important Difference in the Short Physical Performance Battery.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiufang Hong, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429630
- Sponsor's protocol ID
- Clinical Review 2023 No.21K
- Other IDs
- 2018KY198/2022ZH002/2023KY442
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including baseline characteristics, outcome measures, and analysis data sets) will be made available upon reasonable request to the corresponding author, beginning 9 months after article publication and ending 5 years thereafter. Proposals for data use will be reviewed by the study investigators. Requestors will need to sign a data access agreement specifying the intended use of the data, commitment to using it only for the agreed purpose, and agreement not to attempt to re-identify participants.
Publications
Yu P L, Wang J Y. Strengthening the research on prevention and treatment of frailty syndrome in the elderly[J]. Chinese Journal of Geriatrics, 2015, 34(12): 1281.
Hou X L, Gao J, Wu C X, et al. Frailty status and analysis among the elderly in nursing homes[J]. Chinese Journal of Nursing, 2018, 53(01): 88-93.
Liu H X, Yan A Y, Yu W J, et al. Research progress on causes and adverse health outcomes of frailty in the elderly[J]. China Journal of Modern Medicine, 2019, 29(15): 53-57.
Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.
PubMed 28648901Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.
PubMed 25468154Bock JO, Konig HH, Brenner H, Haefeli WE, Quinzler R, Matschinger H, Saum KU, Schottker B, Heider D. Associations of frailty with health care costs--results of the ESTHER cohort study. BMC Health Serv Res. 2016 Apr 14;16:128. doi: 10.1186/s12913-016-1360-3.
PubMed 27074800Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Kojima G. Frailty Defined by FRAIL Scale as a Predictor of Mortality: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2018 Jun;19(6):480-483. doi: 10.1016/j.jamda.2018.04.006.
PubMed 29793675Kojima G. Frailty as a predictor of disabilities among community-dwelling older people: a systematic review and meta-analysis. Disabil Rehabil. 2017 Sep;39(19):1897-1908. doi: 10.1080/09638288.2016.1212282. Epub 2016 Aug 24.
PubMed 27558741Kojima G. Frailty as a predictor of fractures among community-dwelling older people: A systematic review and meta-analysis. Bone. 2016 Sep;90:116-22. doi: 10.1016/j.bone.2016.06.009. Epub 2016 Jun 15.
PubMed 27321894Cheng MH, Chang SF. Frailty as a Risk Factor for Falls Among Community Dwelling People: Evidence From a Meta-Analysis. J Nurs Scholarsh. 2017 Sep;49(5):529-536. doi: 10.1111/jnu.12322. Epub 2017 Jul 29.
PubMed 28755453Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Analysis of a Frailty Management Program: Identifying Characteristics Associated With Improved Physical Performance Following a Combined Nutrition and Exercise Intervention in Hospitalized Frail Older Adults
- ClinicalTrials.gov ID
- NCT07429630
- Acronym / sponsor ID
- Clinical Review 2023 No.21K
- Conditions
- Frail Elderly People Hospitalized
- Keywords
- frail older adults, oral nutritional supplementation, resistance exercise, nutrition, physical function status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Feb 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.
This study aims to evaluate whether a 12-week program combining oral nutritional supplements (ONS) with resistance exercises can improve nutritional status, muscle strength, and physical mobility in hospitalized older adults with frailty. The investigators will enroll about 120 frail older inpatients in a single-group design. All participants will receive 90 grams of ONS daily and undergo supervised resistance training five times per week for 12 weeks. Nutrition, physical function, and frailty levels will be assessed before and after the intervention. Baseline characteristics will be examined as potential predictors of intervention response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective, pre-post intervention study. All enrolled frail older inpatients will receive a standardized 12-week combined intervention consisting of daily oral nutritional supplements and supervised resistance training. The primary analysis will compare outcomes (e.g., physical function, nutritional status) between baseline and post-intervention assessments. Additionally, an exploratory responder analysis is planned to identify baseline predictors of functional improvement based on achieving the Minimal Clinically Important Difference in the Short Physical Performance Battery.
| Arm | Type | Receives |
|---|---|---|
| ONS & Resistance Training Group | Experimental | Combination Product: Combined ONS and Resistance Training Program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age≥65 years
- Ability to understand and communicate in Chinese
- Sufficient hearing and vision to complete assessments
- Ability to walk independently or with assistive devices
Key exclusion criteria (3 listed)
- Acute cardiovascular or cerebrovascular diseases
- Terminal illnesses
- Severe cognitive impairment (determined by the ward's doctor and physiotherapists).
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 |
|---|---|---|
| Combined ONS and Resistance Training ProgramStandardized Combined Intervention (Nutrition + Exercise): A 12-week integrated protocol for all participants. Oral Nutritional Supplement (ONS): Daily intake of 90g whole-protein enteral nutrition powder (450 kcal, 18g protein), dissolved in water and administered in two divided doses. This provides an estimated 30% increase in daily caloric intake. Supervised Resistance Training: Performed 5 times/week using Thera-Band resistance bands. Each 30-minute session includes warm-up, 6 standardized exercises (e.g., front raise, squat, leg abduction) targeting major muscle groups (2-3 sets of 8-12 repetitions each), and cool-down. Exercise intensity and adherence are monitored and progressed biweekly by trained staff. Note: This condensed version retains all critical components (dose, frequency, duration, standardization, supervision, and key exercise descriptions) for protocol replication, within a concise format suitable for study registries or summary documents. | Combination product | ONS & Resistance Training Group |
Primary outcome
Fried frailty phenotype (FP) score
Time frame: Baseline; At 12 weeks post-intervention
Assessed using the Fried Frailty Phenotype (FP) criteria, which includes five components: (1) unintentional weight loss, (2) weakness (grip strength), (3) poor endurance and energy (self-reported exhaustion via CES-D scale), (4) slowness (walking speed), and (5) low physical activity level (MLTA questionnaire). Frailty is defined as meeting three or more criteria. The Fried Frailty Phenotype (FP) score ranges from 0 to 5, with higher scores indicating a greater severity of frailty.
short physical performance battery (SPPB) score
Time frame: Baseline; At 12 weeks post-intervention
Comprises three components: balance tests (side-by-side, semi-tandem, and tandem stands), 4-meter walk speed test, and five times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12. The Short Physical Performance Battery (SPPB) score ranges from 0 to 12 and higher scores reflect better lower extremity function.
9 secondary outcomes
mini nutritional assessment-short form(MNA-SF) score
Time frame: Baseline; At 12 weeks post-intervention
body mass index (BMI)
Time frame: Baseline; At 12 weeks post-intervention
activities of daily living (ADL) score
Time frame: Baseline; At 12 weeks post-intervention
instrumental activities of daily living (IADL) score
Time frame: Baseline; At 12 weeks post-intervention
performance-oriented mobility assessment (POMA) score
Time frame: Baseline; At 12 weeks post-intervention
grip strength
Time frame: Baseline; At 12 weeks post-intervention
serum level of transferrin (TFN)
Time frame: Baseline; At 12 weeks post-intervention
serum level of prealbumin (PA)
Time frame: Baseline; At 12 weeks post-intervention
serum level of albumin (ALB)
Time frame: Baseline; At 12 weeks post-intervention
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 24 Feb 2026.
- Results publicationYu P L, Wang J Y. Strengthening the research on prevention and treatment of frailty syndrome in the elderly[J]. Chinese Journal of Geriatrics, 2015, 34(12): 1281.
- Results publicationHou X L, Gao J, Wu C X, et al. Frailty status and analysis among the elderly in nursing homes[J]. Chinese Journal of Nursing, 2018, 53(01): 88-93.
- Results publicationLiu H X, Yan A Y, Yu W J, et al. Research progress on causes and adverse health outcomes of frailty in the elderly[J]. China Journal of Modern Medicine, 2019, 29(15): 53-57.
- Results publication: PubMed 28648901Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.
- Results publication: PubMed 25468154Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.
- Results publication: PubMed 27074800Bock JO, Konig HH, Brenner H, Haefeli WE, Quinzler R, Matschinger H, Saum KU, Schottker B, Heider D. Associations of frailty with health care costs--results of the ESTHER cohort study. BMC Health Serv Res. 2016 Apr 14;16:128. doi: 10.1186/s12913-016-1360-3.
- Results publication: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Results publication: PubMed 29793675Kojima G. Frailty Defined by FRAIL Scale as a Predictor of Mortality: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2018 Jun;19(6):480-483. doi: 10.1016/j.jamda.2018.04.006.
- Results publication: PubMed 27558741Kojima G. Frailty as a predictor of disabilities among community-dwelling older people: a systematic review and meta-analysis. Disabil Rehabil. 2017 Sep;39(19):1897-1908. doi: 10.1080/09638288.2016.1212282. Epub 2016 Aug 24.
- Results publication: PubMed 27321894Kojima G. Frailty as a predictor of fractures among community-dwelling older people: A systematic review and meta-analysis. Bone. 2016 Sep;90:116-22. doi: 10.1016/j.bone.2016.06.009. Epub 2016 Jun 15.
- Results publication: PubMed 28755453Cheng MH, Chang SF. Frailty as a Risk Factor for Falls Among Community Dwelling People: Evidence From a Meta-Analysis. J Nurs Scholarsh. 2017 Sep;49(5):529-536. doi: 10.1111/jnu.12322. Epub 2017 Jul 29.
- Results publication: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- The official website of Zhejiang HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including baseline characteristics, outcome measures, and analysis data sets) will be made available upon reasonable request to the corresponding author, beginning 9 months after article publication and ending 5 years thereafter. Proposals for data use will be reviewed by the study investigators. Requestors will need to sign a data access agreement specifying the intended use of the data, commitment to using it only for the agreed purpose, and agreement not to attempt to re-identify participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined ONS and Resistance Training Program in people with Frail Elderly People Hospitalized, run by Zhejiang Hospital at 1 site in China.
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 3 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 24 Feb 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 China. 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?
Fried frailty phenotype (FP) score (time frame: Baseline; At 12 weeks post-intervention). 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 NCT07429630, which also lists 12 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 24 Feb 2026.