Post-discharge Nutrition and Resistance Training in Surgical Patients

NCT03327935 | Completed DMC

• 1 other identifier: H-17000004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malnutrition; Surgery

Outcome Measures

Primary Outcomes (1)

• Loss of lean body mass

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

  8 weeks

Study Arms (3)

Nutrition

EXPERIMENTAL

Oral nutritional supplements and dietetic advice

Dietary Supplement: Nutrition

Nutrition and exercise

EXPERIMENTAL

Oral nutritional supplements, dietetic advice and exercise training

Dietary Supplement: Nutrition

Control

NO INTERVENTION

Standard Hospital Procedure

Interventions

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

Nutrition; Nutrition and exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Health Insurance Fund of Research Council Faroe Islands: collaborator
• National Hospital of the Faroe Islands: collaborator
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

National Hospital of Faroe Islands

Tórshavn, 100, Faroe Islands

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Jens Rikardt R Andersen

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 3 groups of 50 patients each by randomization

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 1, 2017
• Study Start: May 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FA (1)