Nutritional Risk, Oral Nutritional Supplements, Rehabilitation
Conditions
Keywords
muscle strenght, quality of life, body composition, protein intake
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTProtein omega-3
An oral supplement with a high content of protein and with essential fatty acids
Sponsors
Herlev and Gentofte Hospital
Nutricia, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
two set of files
Intervention model description
A single-blinded randomised study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Muscle strength | change from baseline to 12 weeks follow-up | Chair stand |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip Muscle strength | change from baseline to 12 weeks follow-up | Hand grip strength |
| Health related quality of life | Change from baseline to 6 and 12 weeks follow-up | 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 |
| Activities of daily living | Change from baseline to 6 and 12 weeks follow-up | 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 |
| energy and protein intake | at 12 weeks follow-up | 24 hour dietary recall |
| Appetite | Change from baseline to 12 week follow-up | Simplified Nutritional Appetite Questionnaire \[SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite |
| Muscle mass | Change from baseline to 12 week follow-up | Calf circumference assessment of muscle mass |
| Frailty | Change from baseline to 12 weeks follow-up | 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 |
| initiation and completion of rehabilitation | at 12 week follow-up | questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending. |
| compliance to oral nutritional supplements | at 12 weeks follow-up | a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal |
| readmissions | 30 days and 38 weeks after discharge | number, length and percentage of readmissions after discharge will be calculated |
| mortality | 30 days and 38 weeks after discharge | number and percentage of mortality after discharge will be calculated |
| inflammation | change from baseline to 12 weeks follow-up | blood measurements of CRP and omega-3 fatty acids |
| vitamin D status | change from baseline to 12 weeks follow-up | blood measurements of vitamin D |
| Hydration status | Change from Baseline to 12 weeks follow up | Blood measurements and calculation of serum osmolarity |
Countries
Denmark
Contacts
STUDY_DIRECTORTina Munk, PhD
Herlev and Gentofte Hospital
Outcome results
None listed