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

Rehabilitation Clinical Trial

— NUTRIMUSCLE  

Official title:

Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556876
• Other study ID #: version2/30.03.2022
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2023
• Source: Herlev and Gentofte Hospital
• Contact: Anne Marie Beck, PhD
• Phone: 38682387
• Email: anne.marie.beck[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: March 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Risk
• Oral Nutritional Supplements
• Rehabilitation

Intervention

Dietary Supplement:
• Protein omega-3
An oral supplement with a high content of protein and with essential fatty acids

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Nutricia, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg Muscle strength	Chair stand	change from baseline to 12 weeks follow-up
Secondary	Hand grip Muscle strength	Hand grip strength	change from baseline to 12 weeks follow-up
Secondary	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	Change from baseline 12 weeks follow-up
Secondary	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	Change from baseline to 12 weeks follow-up
Secondary	energy and protein intake	24 hour dietary recall	at 12 weeks follow-up
Secondary	Appetite	Simplified Nutritional Appetite Questionnaire [SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite	Change from baseline to 12 week follow-up
Secondary	Muscle mass	Bio impedance measurement of body composition	Change from baseline to 12 week follow-up
Secondary	Frailty	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	Change from baseline to 12 weeks follow-up
Secondary	initiation and completion of rehabilitation	questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending.	at 12 week follow-up
Secondary	compliance to oral nutritional supplements	a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal	at 12 weeks follow-up
Secondary	readmissions	number, length and percentage of readmissions after discharge will be calculated	38 weeks after discharge
Secondary	mortality	number and percentage of mortality after discharge will be calculated	38 weeks after discharge
Secondary	inflammation	blood measurements of CRP and omega-3 fatty acids	change from baseline to 12 weeks follow-up
Secondary	vitamin D status	blood measurements of vitamin D	change from baseline to 12 weeks follow-up