Post-discharge Nutrition and Resistance Training in Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Malnutrition Assessment Tools in Surgery

NCT05393752

Malnutrition Surgery--Complications

COMPLETED

Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome

NCT01492946

Nutritional Status

COMPLETED

The Impact of Preoperative FoodforCare at Home

NCT03488511

Surgery

COMPLETED NA

Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery

NCT00546975

Patients Following Gastrointestinal Surgery

TERMINATED NA

Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome

NCT04039035

Preoperative Nutritional Status and the Postoperative Outcome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups of 50 patients each by randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutrition

Oral nutritional supplements and dietetic advice

Group Type EXPERIMENTAL

Nutrition

Intervention Type 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 and exercise

Oral nutritional supplements, dietetic advice and exercise training

Group Type EXPERIMENTAL

Nutrition

Intervention Type 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

Control

Standard Hospital Procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No