The Effect of Protein and Resistance Training on Muscle Mass in Acutely Ill Old Medical Patients
|ClinicalTrials.gov Identifier: NCT02077491|
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : May 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammatory Response Syndrome||Other: High-protein diet and resistance training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Protein and Resistance Training on Muscle Mass, Muscle Strength and Functional Ability in Acutely Ill Old Medical Patients; a Randomized Controlled Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: Intervention
High-protein diet and resistance training
Other: High-protein diet and resistance training
The intervention includes 1.7g/kg/day during admission combined with resistance training and a daily protein and energy supplement after discharge.
No Intervention: Control
The control group recieves standard care during the study.
- Muscle mass (lean mass) [ Time Frame: Change from baseline in muscle mass at 3 month after discharge ]
Whole body Dual-X-ray-Absorptiometry (DXA) scans are used to measure muscle mass. The scanner used is a 'Hologic Discovery A DXA scan'. Quality Control of the DXA scan will be performed and approved before initiating any scans. Before performing DXA scans patients are asked to remove all metal-containing items. If it is not possible to remove all metal-containing items the research assistant will document this.
The examination provides information about total muscle mass and allows for analysis of muscle mass on extremities. All analysis will be performed by trained personal.
- Functional ability [ Time Frame: Change from baseline in functional ability at 3 month after discharge ]A combination of questionnaires, 'Functional Recovery Score' and 'New Mobility Score', and physical test, 'De Morton Mobility Index' are performed to assess the functional ability of the included patients. 'Functional Recovery Score' and 'New Mobility Score' are used retrospectively at the time of admission and prospectively at one and three months after discharge.
- Muscle strength [ Time Frame: Change from baseline in muscle strength at 3 month after discharge ]
Muscle strength is measured by two exercises. A 30 seconds chair stand test provides a measurement of the patient's muscle strength in the lower extremities. In this test the patient is instructed to sit in a chair and place their hands on the opposite shoulder crossed at the wrists. On a signal the patient is instructed to rise to full stand position and then sit back down again. This is repeated as many times as possible within 30 seconds.
Handgrip strength provides a measure of the patient's strength in the upper extremities. A hand dynamometer is used to measure the maximal isometric strength in the dominant hand. The test is performed while patients are sitting in a chair. The elbow is bend in a angle of 90 degrees and the wrist is kept neutral. When ready the patient squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The test is repeated three times and the best result is registered.
- Body weight [ Time Frame: Change from baseline in body weight at 3 month after discharge ]Body weight is measured on a traditional transportable scale. Patients are measured in light clothing and without shoes.
- Biomarkers [ Time Frame: Change from baseline in biomarkers at 3 month after discharge ]Blood samples are taken in 2 x 10 ml EDTA-glasses. The blood samples are centrifuged at 2500 g, in 20 minutes at 4 degrees Celsius. Plasma is stored in a minus 80 degrees freezer until time for analysis. The following biomarkers will, among others, be analysed: soluble urokinase plasminogen activating receptor (suPAR), Interleukin-6 (IL-6), Leptin, Adiponektin, procollagen type-1 n-terminal (p1np), osteocalcin and Bone Specific Alkaline Phosphatase (BSAP).
- Bone Mineral Density [ Time Frame: Change from baseline in bone mineral density at 3 month after discharge ]Regional Dual-X-ray-Absorptiometry (DXA) scans are used to assess changes in Bone Mineral Density. The examination includes scan of lower-arm, lower-back and hip. The scanner used is a 'Hologic Discovery A DXA scan'. Quality Control of the DXA scan will be performed and approved before initiating any scans. Before performing DXA scans patients are asked to remove all metal-containing items. If it is not possible to remove all metal-containing items the research assistant will document this.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077491
|Klinisk Forskningscenter, Amager & Hvidovre Hospitaler|
|Copenhagen, Hvidovre, Denmark, 2650|
|Study Chair:||Ove Andersen, Md, PhD||Clinical Research Centre, Amager Hvidovre Hospital|