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| Name | Class |
|---|---|
| Nutricia, Inc. | INDUSTRY |
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The purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation
The study is a single-blind randomised study where the subjects will be randomly divided into two groups. A group that must consume nutritional drinks in connection with their rehabilitation and a group that must do nothing extra. Based on a statistical power calculation, we will include a total of 124 patients.
In connection with the experiment, different data will be collected three times, in connection with the discharge from the hospital, after 6 weeks via the telephone and after 12 weeks. During a home visit. Here, various questionnaires will have to be answered and data on muscle strength and muscle mass will be collected. Further CRP, vitamin D status and EPA/DHA content in blood will be assessed.
In addition, data is collected from the patient's medical record about e.g. readmissions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge |
|
| Control | No Intervention | the control group will receive usual care after discharge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein omega-3 | Dietary Supplement | An oral supplement with a high content of protein and with essential fatty acids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leg Muscle strength | Chair stand | change from baseline to 12 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip Muscle strength | Hand grip strength | change from baseline to 12 weeks follow-up |
| Health related quality of life | EQ5D5L questionnaire with five dimensions and five level of answers. To be converted to an index were -1 is worst and 1 is best health related quality of life |
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Inclusion Criteria:
Men and women aged ≥ 65 years old
Independent stand function
Exclusion Criteria:
Active cancer
Renal insufficiency (eGFR < 27 mL/min/1.73m2)
Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
Terminal disease
Exclusively receiving texture modified food, enteral or parenteral nutrition
Planning to lose weight/go on a special diet
Planned transfer to other hospitals/departments
Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA)
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| Name | Affiliation | Role |
|---|---|---|
| Tina Munk, PhD | Herlev and Gentofte Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte hospital | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42299674 | Result | Jensen A, Ninh ED, Knudsen AW, Munk T, Beck AM. Effect of oral nutritional supplements on mortality and hospital admissions in older hip fracture patients at nutritional risk: secondary analysis of a randomised controlled trial. Clin Rehabil. 2026 Jun 16:2692155261459227. doi: 10.1177/02692155261459227. Online ahead of print. | |
| 42383884 |
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A single-blinded randomised study
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two set of files
| Change from baseline to 6 and 12 weeks follow-up |
| Activities of daily living | Functional recovery score The eleven-item questionnaire is comprised of three main components: basic activities of daily living (BADL) assessed by four items, instrumental activities of daily living (IADL) assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent | Change from baseline to 6 and 12 weeks follow-up |
| energy and protein intake | 24 hour dietary recall | at 12 weeks follow-up |
| Appetite | Simplified Nutritional Appetite Questionnaire [SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite](streamdown:incomplete-link) | Change from baseline to 12 week follow-up |
| Muscle mass | Calf circumference assessment of muscle mass | Change from baseline to 12 week follow-up |
| Frailty | The "FRAIL" Questionnaire includes questions concerning Fatigue, Resistance (capability of stair climbing),Aerobic( walking distance), Illnesses (multi morbidity), and Loss of weight. Physical frailty, pre-frailty and non-frailty is defined as having 3 or greater; 1 or 2 or no factors respectively | Change from baseline to 12 weeks follow-up |
| initiation and completion of rehabilitation | questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending. | at 12 week follow-up |
| compliance to oral nutritional supplements | a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal | at 12 weeks follow-up |
| readmissions | number, length and percentage of readmissions after discharge will be calculated | 30 days and 38 weeks after discharge |
| mortality | number and percentage of mortality after discharge will be calculated | 30 days and 38 weeks after discharge |
| inflammation | blood measurements of CRP and omega-3 fatty acids | change from baseline to 12 weeks follow-up |
| vitamin D status | blood measurements of vitamin D | change from baseline to 12 weeks follow-up |
| Hydration status | Blood measurements and calculation of serum osmolarity | Change from Baseline to 12 weeks follow up |
| Jensen A, Ninh ED, Darlem BB, Haack LM, Moller CM, Knudsen AW, Pudselykke FE, Petersen PB, Beck AM. Effect of oral nutritional supplements on physical functional performance in older patients at nutritional risk discharged with a rehabilitation plan: A randomised controlled trial. Clin Rehabil. 2026 Jul 1:2692155261462462. doi: 10.1177/02692155261462462. Online ahead of print. |
| 41566545 | Result | Jensen A, Ninh ED, Tetens I, Beck AM. Oral nutritional supplements for older hip fracture patients at nutritional risk (NUTRI-MUSCLES)-a feasibility trial for a two-armed RCT. Pilot Feasibility Stud. 2026 Jan 21;12(1):26. doi: 10.1186/s40814-026-01763-4. |