NCT03855670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

February 21, 2019

Last Update Submit

March 8, 2022

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Rate of acute exacerbations of COPD

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

    12 months

Secondary Outcomes (8)

  • Physical activity

    12 months

  • Fat-free mass index

    12 months

  • Hand grip strenght

    12 months

  • C-reactive protein

    12 months

  • Total protein

    12 months

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study cohort will be selected by the Cantonal Hospital St. Gallen (primary care clinic)

You may qualify if:

  • COPD GOLD stage B or higher
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lung Center, Cantonal Hospital St. Gallen

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

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 27, 2019

Study Start

November 29, 2018

Primary Completion

August 6, 2021

Study Completion

August 6, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)