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| ID | Type | Description | Link |
|---|---|---|---|
| 2018KY198/2022ZH002/2023KY442 | Other Grant/Funding Number | Zhejiang Provincial Medical and Health Science and Technology Program |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS & Resistance Training Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined ONS and Resistance Training Program | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline; At 12 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Hospital | Hangzhou | Zhejiang | 310013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| Result | 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. | ||
| 28648901 | Result | 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. |
| Label | URL |
|---|---|
| The official website of Zhejiang Hospital | View source |
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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.
De-identified IPD and supporting documents (study protocol, informed consent form) will become available 9 months after the publication of the primary results manuscript and will remain available for 5 years. Access will be provided upon reasonable request to the corresponding author and require a signed data use agreement.
Access will be granted to qualified researchers (affiliated with academic or healthcare institutions) who provide a methodologically sound research proposal approved by the study investigators. Requestors can access de-identified IPD, study protocol, and informed consent form for the purpose of individual participant data meta-analysis, reproducibility checks, or secondary analysis aligned with the original study ethics. Proposals should be submitted to the corresponding author [hongxf_1101@163.com] and require a signed Data Access/Use Agreement that includes commitments to: (1) use data only for the specified purpose; (2) protect data confidentiality; (3) not attempt to re-identify participants; and (4) acknowledge the data source in publications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 22, 2022 | Feb 12, 2026 | Prot_SAP_ICF_000.pdf |
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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.
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| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | Baseline; At 12 weeks post-intervention |
| 25468154 | Result | Rodriguez-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. |
| 27074800 | Result | Bock 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. |
| 23395245 | Result | Clegg 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. |
| 29793675 | Result | Kojima 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. |
| 27558741 | Result | Kojima 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. |
| 27321894 | Result | Kojima 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. |
| 28755453 | Result | Cheng 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. |
| 11253156 | Result | Fried 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. |