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| Name | Class |
|---|---|
| Health Insurance Fund of Research Council Faroe Islands | UNKNOWN |
| National Hospital of the Faroe Islands | OTHER_GOV |
| Société des Produits Nestlé (SPN) | INDUSTRY |
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Randomized intervention by nutritional supplements and training in postoperative patients after discharge
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition | Experimental | Oral nutritional supplements and dietetic advice |
|
| Nutrition and exercise | Experimental | Oral nutritional supplements, dietetic advice and exercise training |
|
| Control | No Intervention | Standard Hospital Procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of lean body mass | Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Rikardt R Andersen | University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital of Faroe Islands | Tórshavn | 100 | Faroe Islands |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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3 groups of 50 patients each by randomization
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Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.
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|
| D003710 | Demography |
| D011154 | Population Characteristics |