Post-discharge Nutrition and Resistance Training in Surgical Patients

Not Applicable

Completed

• Conditions: Surgery; Malnutrition
• Interventions: Dietary Supplement: Nutrition

• Registration Number: NCT03327935
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Study Start: 2018-05-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition	Nutrition	Oral nutritional supplements and dietetic advice
Nutrition and exercise	Nutrition	Oral nutritional supplements, dietetic advice and exercise training

Primary Outcome Measures

Name	Time	Method
Loss of lean body mass	8 weeks	Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans

Trial Locations

Locations (1)

National Hospital of Faroe Islands; 🇫🇴 Tórshavn, Faroe Islands