Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan

Conditions
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Nutritional Risk, Rehabilitation, Oral Nutritional Supplements

Intervention / Treatment
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* Dietary Supplement: Protein omega-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged ≥ 65 years old Independent stand function Able to speak and understand Danish At nutritional risk according to NRS-2002 (Expected to be) discharged with a new rehabilitation plan Admitted to the medical and orthopaedic departments of Gentofte or Herlev Hospital 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) Taking fish-oil supplements as a medical prescription due to hypertriglyceridemia Taking fish-oil supplements for other reasons and do not wish to stop this during the study period

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-blinded randomised study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge | Dietary Supplement: Protein omega-3<br>* An oral supplement with a high content of protein and with essential fatty acids<br>|
| No Intervention: Control<br>the control group will receive usual care after discharge | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Muscle strength | Chair stand | change from baseline to 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 | Change from baseline 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 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 | Change from baseline to 12 week follow-up | 
| Muscle mass | Bio impedance measurement of body composition | 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 | 38 weeks after discharge | 
| mortality | number and percentage of mortality after discharge will be calculated | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle strenght, quality of life, body composition, protein intake