Post-discharge Nutrition and Resistance Training in Surgical Patients

Surgery Clinical Trial

— MaSu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327935
• Other study ID #: H-17000004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Surgery

Intervention

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

Locations

Country	Name	City	State
Faroe Islands	National Hospital of Faroe Islands	Tórshavn

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Health Insurance Fund of Research Council Faroe Islands, National Hospital of the Faroe Islands, Nestlé

Country where clinical trial is conducted

Faroe Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of lean body mass	Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans	8 weeks