The Role of Physical Activity for Acute Exacerbations of COPD

Completed

• Conditions: COPD

• Registration Number: NCT03855670
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

The investigators plan to study the association between physical activity, malnutrition and sarcopenia and the occurrence of acute exacerbations of COPD / the evolution of the COPD assessment test (CAT) over 1 year in a telehealthcare cohort of patients with COPD. The investigators hypothesize that malnutrition and/or sarcopenia at baseline and a decline in the fat-free mass index over time is associated with an increased rate of acute exacerbations of COPD and an increased CAT score meaning a higher risk for mortality, morbidity and impairment of quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-29
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Primary Completion: 2021-08-06
• Study Completion: 2021-08-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• COPD GOLD stage B or higher
• Written informed consent

Exclusion Criteria

• Inability to provide written informed consent
• Insufficient knowledge of the trial language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of acute exacerbations of COPD	12 months	The primary outcome measure is the rate of acute exacerbations of COPD.

Secondary Outcome Measures

Name	Time	Method
Fat-free mass index	12 months	The rate of acute exacerbations of COPD will be correlated to the fat-free mass index (FFMI) measured at baseline and after 6 and 12 months using bioelectrical impedance analysis (BIA).
Physical activity	12 months	The rate of acute exacerbations of COPD will be correlated to the degree of physical activity measured using an activity tracker in everyday life. The following parameters will be recorded: * step count; * distance travelled; * calories burned
Hand grip strenght	12 months	The rate of acute exacerbations of COPD will be correlated to the hand grip strength (HGS) measured at baseline and after 6 and 12 months using a dynamometer.
25-OH vitamin D3	12 months	The rate of acute exacerbations of COPD will be correlated to the level of serum 25-OH vitamin D3 measured at baseline and after 6 and 12 months.
C-reactive protein	12 months	The rate of acute exacerbations of COPD will be correlated to the level of serum C-reactive protein (CRP) measured at baseline and after 6 and 12 months.
Total protein	12 months	The rate of acute exacerbations of COPD will be correlated to the level of total serum protein measured at baseline and after 6 and 12 months.
COPD assessment test	12 months	The rate of acute exacerbations of COPD will be correlated to the COPD assessment test (CAT) score which interrogated on a weekly basis.
Albumin	12 months	The rate of acute exacerbations of COPD will be correlated to the level of serum albumin measured at baseline and after 6 and 12 months.

Trial Locations

Locations (1)

Lung Center, Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland