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

Not Applicable

Recruiting

• Conditions: Nutritional Risk; Oral Nutritional Supplements; Rehabilitation
• Interventions: Dietary Supplement: Protein omega-3

• Registration Number: NCT05556876
• Lead Sponsor: Herlev and Gentofte Hospital

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 Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2023-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-11-30
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Protein omega-3	the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge

Primary Outcome Measures

Name	Time	Method
Leg Muscle strength	change from baseline to 12 weeks follow-up	Chair stand

Secondary Outcome Measures

Name	Time	Method
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.
Hand grip Muscle strength	change from baseline to 12 weeks follow-up	Hand grip strength
Health related quality of life	Change from baseline 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 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
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	38 weeks after discharge	number, length and percentage of readmissions after discharge will be calculated
mortality	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

Trial Locations

Locations (1)

Herlev and Gentofte hospital; 🇩🇰 Herlev, Denmark