Post-discharge Nutrition and Resistance Training in Surgical Patients (MaSu)
Primary Purpose
Malnutrition, Surgery
Status
Completed
Phase
Not Applicable
Locations
Faroe Islands
Study Type
Interventional
Intervention
Nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
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
Sites / Locations
- National Hospital of Faroe Islands
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Nutrition
Nutrition and exercise
Control
Arm Description
Oral nutritional supplements and dietetic advice
Oral nutritional supplements, dietetic advice and exercise training
Standard Hospital Procedure
Outcomes
Primary Outcome Measures
Loss of lean body mass
Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans
Secondary Outcome Measures
Full Information
NCT ID
NCT03327935
First Posted
October 27, 2017
Last Updated
July 21, 2020
Sponsor
University of Copenhagen
Collaborators
Health Insurance Fund of Research Council Faroe Islands, National Hospital of the Faroe Islands, Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT03327935
Brief Title
Post-discharge Nutrition and Resistance Training in Surgical Patients
Acronym
MaSu
Official Title
Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Health Insurance Fund of Research Council Faroe Islands, National Hospital of the Faroe Islands, Société des Produits Nestlé (SPN)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized intervention by nutritional supplements and training in postoperative patients after discharge
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups of 50 patients each by randomization
Masking
None (Open Label)
Masking Description
Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition
Arm Type
Experimental
Arm Description
Oral nutritional supplements and dietetic advice
Arm Title
Nutrition and exercise
Arm Type
Experimental
Arm Description
Oral nutritional supplements, dietetic advice and exercise training
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard Hospital Procedure
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
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
Primary Outcome Measure Information:
Title
Loss of lean body mass
Description
Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt R Andersen
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
National Hospital of Faroe Islands
City
Tórshavn
ZIP/Postal Code
100
Country
Faroe Islands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-discharge Nutrition and Resistance Training in Surgical Patients
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