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Completed

NCT Number: NCT03327935

Post-discharge Nutrition and Resistance Training in Surgical Patients

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital of Faroe Islands

Tórshavn, 100, Faroe Islands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition

Dietary Supplement

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 outcomes

  1. Loss of lean body mass

    Time frame: 8 weeks

    Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Health Insurance Fund of Research Council Faroe Islands
  • National Hospital of the Faroe Islands
  • Société des Produits Nestlé (SPN)

Registry information

Official study title

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

Acronym: MaSu

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2017
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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