The Role of Physical Activity for Acute Exacerbations of COPD

COPD Clinical Trial

Official title:

The Role of Physical Activity, Malnutrition and Sarcopenia for the Prediction of Acute Exacerbations and the Evolution of COPD Assessment Test (CAT) in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855670
• Other study ID #: EKOS 18/055
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: August 6, 2021

Study information

• Verified date: March 2022
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Switzerland	Lung Center, Cantonal Hospital St. Gallen	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of acute exacerbations of COPD	The primary outcome measure is the rate of acute exacerbations of COPD.	12 months
Secondary	Physical activity	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	12 months
Secondary	Fat-free mass index	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).	12 months
Secondary	Hand grip strenght	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.	12 months
Secondary	C-reactive protein	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.	12 months
Secondary	Total protein	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.	12 months
Secondary	Albumin	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.	12 months
Secondary	25-OH vitamin D3	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.	12 months
Secondary	COPD assessment test	The rate of acute exacerbations of COPD will be correlated to the COPD assessment test (CAT) score which interrogated on a weekly basis.	12 months

External Links

•   Cantonal Hospital St. Gallen
•   Lung Center, Cantonal Hospital St.Gallen