The Effect of Protein and Resistance Training on Muscle Mass in Acutely Ill Old Medical Patients

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Københavns Kommune
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT02077491
First received: February 7, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the effect of a high-protein diet during hospitalization in combination with resistance training and a daily protein and energy supplement three months after discharge on the muscle mass, muscle strength, functional ability and weight in acutely ill old medical patients.


Condition Intervention
Systemic Inflammatory Response Syndrome
Other: High-protein diet and resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Muscle mass (lean mass) [ Time Frame: Change from baseline in muscle mass at 3 month after discharge ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Functional ability [ Time Frame: Change from baseline in functional ability at 3 month after discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 32
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acutely admitted to Amager Hvidovre Hospital, Copenhagen, Denmark
  • > 65 years
  • Medical patients
  • Understands and speaks Danish
  • Fulfill the criteria's of Systemic Inflammatory Response Syndrome

Exclusion Criteria:

  • Terminal illnesses
  • Cancer
  • Glomerular Filtration Rate < 60 ml/min
  • Not able to stand
  • Not able to understand the purpose of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077491

Locations
Denmark
Klinisk Forskningscenter, Amager & Hvidovre Hospitaler
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Københavns Kommune
Investigators
Study Chair: Ove Andersen, Md, PhD Clinical Research Centre, Amager Hvidovre Hospital
  More Information

No publications provided

Responsible Party: Ove Andersen, Head of the Research Center, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02077491     History of Changes
Other Study ID Numbers: H-2-2013-013, H-2-2013-013
Study First Received: February 7, 2014
Last Updated: May 29, 2014
Health Authority: Denmark: De Videnskabsetiske Komitéer for Region Hovedstaden

Keywords provided by Hvidovre University Hospital:
Aged
Systemic Inflammatory Response Syndrome
Body Composition
Dietary Protein

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on July 31, 2014