Clinical trial NCT05556876: Effect of Oral Nutritional Supplements to Older Patients Discharged with a Rehabilitation Plan
Official title: Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients At Nutritional Risk Discharged with a Rehabilitation Plan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional Risk
Rehabilitation
Oral Nutritional Supplements
Keywords: muscle strenght
quality of life
body composition
protein intake
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Nutricia, Inc.
First posted: 2022-09-27
Enrollment: 124
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded randomised study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Leg Muscle strength
timeFrame: change from baseline to 12 weeks follow-up
Secondary outcomes:
measure: Hand grip Muscle strength
timeFrame: change from baseline to 12 weeks follow-up
measure: Health related quality of life
timeFrame: Change from baseline 12 weeks follow-up
measure: Activities of daily living
timeFrame: Change from baseline to 12 weeks follow-up
measure: energy and protein intake
timeFrame: at 12 weeks follow-up
measure: Appetite
timeFrame: Change from baseline to 12 week follow-up
measure: Muscle mass
timeFrame: Change from baseline to 12 week follow-up
measure: Frailty
timeFrame: Change from baseline to 12 weeks follow-up
measure: initiation and completion of rehabilitation
timeFrame: at 12 week follow-up
measure: compliance to oral nutritional supplements
timeFrame: at 12 weeks follow-up
measure: readmissions
timeFrame: 38 weeks after discharge
measure: mortality
timeFrame: 38 weeks after discharge
measure: inflammation
timeFrame: change from baseline to 12 weeks follow-up
measure: vitamin D status
timeFrame: change from baseline to 12 weeks follow-up
measure: Hydration status
timeFrame: Change from Baseline to 12 weeks follow up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte hospital
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Tina Munk, PhD
role: STUDY_DIRECTOR
References: