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

NCT02077491 | Completed DMC

• 1 other identifier: H-2-2013-013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Aged; Systemic Inflammatory Response Syndrome; Body Composition; Dietary Protein

Outcome Measures

Primary Outcomes (1)

• Muscle mass (lean mass)

  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.

  Change from baseline in muscle mass at 3 month after discharge

Secondary Outcomes (5)

• Functional ability

  Change from baseline in functional ability at 3 month after discharge

• Muscle strength

  Change from baseline in muscle strength at 3 month after discharge

• Body weight

  Change from baseline in body weight at 3 month after discharge

• Biomarkers

  Change from baseline in biomarkers at 3 month after discharge

• Bone Mineral Density

  Change from baseline in bone mineral density at 3 month after discharge

Study Arms (2)

Intervention

ACTIVE COMPARATOR

High-protein diet and resistance training

Other: High-protein diet and resistance training

Control

NO INTERVENTION

The control group recieves standard care during the study.

Interventions

High-protein diet and resistance training OTHER

The intervention includes 1.7g/kg/day during admission combined with resistance training and a daily protein and energy supplement after discharge.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Terminal illnesses
• Cancer
• Glomerular Filtration Rate \< 60 ml/min
• Not able to stand
• Not able to understand the purpose of the study

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Københavns Kommune: collaborator

Study Sites (1)

Klinisk Forskningscenter, Amager & Hvidovre Hospitaler

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Buhl SF, Andersen AL, Andersen JR, Andersen O, Jensen JB, Rasmussen AML, Pedersen MM, Damkjaer L, Gilkes H, Petersen J. The effect of protein intake and resistance training on muscle mass in acutely ill old medical patients - A randomized controlled trial. Clin Nutr. 2016 Feb;35(1):59-66. doi: 10.1016/j.clnu.2015.02.015. Epub 2015 Mar 5.

  PMID: 25796103 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Diet, High-Protein; Resistance Training

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ove Andersen, Md, PhD

  Clinical Research Centre, Amager Hvidovre Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research Center, Medical Doctor

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: March 4, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

DK (1)