Post-discharge Nutrition and Resistance Training in Surgical Patients (MaSu)

Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training

Randomized intervention by nutritional supplements and training in postoperative patients after discharge

Study Overview

• Status: Completed
• Conditions: Malnutrition; Surgery
• Intervention / Treatment: Dietary supplement: Nutrition

Detailed Description

Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Faroe Islands
  • Tórshavn, Faroe Islands, 100
    • National Hospital of Faroe Islands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands
• Aged 18 years or above
• One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery
• At nutritional risk according to screening

Exclusion Criteria:

• Minimally invasive surgery/Laparoscopic surgery
• Severely reduced kidney function (p-creatinin>250 mikromol/l) or dialysis
• Terminal illness
• Inability to cooperate in tests or exercises due to cognitive function or dementia
• Admitted to intensive care unit
• Inability to speak or understand Faroese, Danish or English
• Consent according to national regulations not obtainable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutrition; Oral nutritional supplements and dietetic advice	Dietary supplement: Nutrition; 150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass
EXPERIMENTAL: Nutrition and exercise; Oral nutritional supplements, dietetic advice and exercise training	Dietary supplement: Nutrition; 150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass
NO_INTERVENTION: Control; Standard Hospital Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of lean body mass	Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans	8 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Nestlé; Health Insurance Fund of Research Council Faroe Islands; National Hospital of the Faroe Islands
• Investigators: Study Chair: Jens Rikardt R Andersen, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (ACTUAL): November 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: H-17000004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No