The Role of Physical Activity for Acute Exacerbations of COPD

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03855670

Enrollment

Registered

2019-02-27

Start date

2018-11-29

Completion date

2021-08-06

Last updated

2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of acute exacerbations of COPD	12 months	The primary outcome measure is the rate of acute exacerbations of COPD.

Secondary

Measure	Time frame	Description
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).
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.
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.
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
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.
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.
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.
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.

Countries

Switzerland

Outcome results