Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Herlev and Gentofte Hospital
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Leg Muscle strength
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
two set of files
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention
the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge
Intervention: Protein omega-3 (Dietary Supplement)
Control
the control group will receive usual care after discharge
Outcomes
Primary Outcomes
Leg Muscle strength
Time Frame: change from baseline to 12 weeks follow-up
Chair stand
Secondary Outcomes
- Hand grip Muscle strength(change from baseline to 12 weeks follow-up)
- Health related quality of life(Change from baseline to 6 and 12 weeks follow-up)
- Activities of daily living(Change from baseline to 6 and 12 weeks follow-up)
- energy and protein intake(at 12 weeks follow-up)
- Appetite(Change from baseline to 12 week follow-up)
- Muscle mass(Change from baseline to 12 week follow-up)
- Frailty(Change from baseline to 12 weeks follow-up)
- initiation and completion of rehabilitation(at 12 week follow-up)
- readmissions(30 days and 38 weeks after discharge)
- compliance to oral nutritional supplements(at 12 weeks follow-up)
- mortality(30 days and 38 weeks after discharge)
- inflammation(change from baseline to 12 weeks follow-up)
- vitamin D status(change from baseline to 12 weeks follow-up)
- Hydration status(Change from Baseline to 12 weeks follow up)
- Hand grip Muscle strength(change from baseline to 12 weeks follow-up)
- energy and protein intake(at 12 weeks follow-up)
- Appetite(Change from baseline to 12 week follow-up)
- Muscle mass(Change from baseline to 12 week follow-up)
- Frailty(Change from baseline to 12 weeks follow-up)
- initiation and completion of rehabilitation(at 12 week follow-up)
- compliance to oral nutritional supplements(at 12 weeks follow-up)
- inflammation(change from baseline to 12 weeks follow-up)
- vitamin D status(change from baseline to 12 weeks follow-up)
- Hydration status(Change from Baseline to 12 weeks follow up)
- Health related quality of life(Change from baseline to 6 and 12 weeks follow-up)
- Activities of daily living(Change from baseline to 6 and 12 weeks follow-up)
Investigators
Anne Marie Beck
Senior researcher
Herlev and Gentofte Hospital