Clinical outcome and cost effectiveness analysis of nutritional rehabilitation on physical functioning and cardiometabolic risk profile in COPD patients with muscle atrophy

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; 10006436

• Registration Number: NL-OMON36746
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Clinically stable COPD patients with muscle atrophy eligible for pulmonary rehabilitation. Based on recent studies in COPD and health reference groups, muscle atrophy is defined as a fat-free mass index (FFMI) under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA.
Subjects have to be aged over 18, may not get pregnant during the study and have to stop possible intake of current nutritional supplements.Eligible patients will be included after signing informed consent.

Exclusion Criteria

-COPD patients under the age of 18;
-Allergy or intolerance to fish, milk or other product components;
-Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
-Not able to stop current supplement use or if total use will be above safe upper limits;
-Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
-Pregnancy;
-Life threatening diseases like tuberculosis, carcinoma, AIDS (including HIV+), acute leukaemia etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameter (measured at baseline and after 4 and 12 months):<br /><br><br /><br>1.Skeletal muscle strength<br /><br>-Isokinetic dynamometry (Biodex®)</p><br>