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

Herlev and Gentofte Hospital123 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

123

Conditions

Nutritional Risk Rehabilitation Oral Nutritional Supplements

Interventions

Protein omega-3DIETARY_SUPPLEMENT

An oral supplement with a high content of protein and with essential fatty acids

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Herlev and Gentofte hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Leg Muscle strength

Chair stand

Time frame: change from baseline to 12 weeks follow-up

Secondary Outcomes

Hand grip Muscle strength

Hand grip strength

Time frame: 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

Time frame: 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

Time frame: Change from baseline to 6 and 12 weeks follow-up

energy and protein intake

24 hour dietary recall

Time frame: 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

Time frame: Change from baseline to 12 week follow-up

Muscle mass

Data from ClinicalTrials.gov

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