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OpenTrials
Completed

NCT Number: NCT03855670

The Role of Physical Activity for Acute Exacerbations of COPD

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Lung Center, Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of acute exacerbations of COPD

    Time frame: 12 months

    The primary outcome measure is the rate of acute exacerbations of COPD.

Secondary outcomes

  1. Physical activity

    Time frame: 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

  2. Fat-free mass index

    Time frame: 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).

  3. Hand grip strenght

    Time frame: 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.

  4. C-reactive protein

    Time frame: 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.

  5. Total protein

    Time frame: 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.

  6. Albumin

    Time frame: 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.

  7. 25-OH vitamin D3

    Time frame: 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.

  8. COPD assessment test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2019
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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