COPDNCT03855670
The Role of Physical Activity for Acute Exacerbations of COPD
An observational study of COPD, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Nov 2018to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study cohort will be selected by the Cantonal Hospital St. Gallen (primary care clinic)
Who may be able to join
- COPD GOLD stage B or higher
- Written informed consent
Who cannot join
- Inability to provide written informed consent
- Insufficient knowledge of the trial language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lung Center, Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
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
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.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute exacerbations of COPD
The primary outcome measure is the rate of acute exacerbations of COPD.
Measured: 12 months
Secondary outcomes (8)
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
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start29 Nov 2018
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Boesch, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855670
- Sponsor's protocol ID
- EKOS 18/055
- Status last verified
- Mar 2022
- First submitted
- 21 Feb 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boesch M, Baty F, Bilz S, Brutsche MH, Rassouli F. Tracking Real-World Physical Activity in Chronic Obstructive Pulmonary Disease Over One Year: Results from a Monocentric, Prospective, Observational Cohort Study. Int J Chron Obstruct Pulmon Dis. 2024 Aug 27;19:1921-1929. doi: 10.2147/COPD.S469984. eCollection 2024.
PubMed 39219563
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03855670
- Acronym / sponsor ID
- EKOS 18/055
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study cohort will be selected by the Cantonal Hospital St. Gallen (primary care clinic)
Key inclusion criteria (2 listed)
- COPD GOLD stage B or higher
- Written informed consent
Key exclusion criteria (2 listed)
- Inability to provide written informed consent
- Insufficient knowledge of the trial language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of acute exacerbations of COPD
Time frame: 12 months
The primary outcome measure is the rate of acute exacerbations of COPD.
8 secondary outcomes
Physical activity
Time frame: 12 months
Fat-free mass index
Time frame: 12 months
Hand grip strenght
Time frame: 12 months
C-reactive protein
Time frame: 12 months
Total protein
Time frame: 12 months
Albumin
Time frame: 12 months
25-OH vitamin D3
Time frame: 12 months
COPD assessment test
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 39219563Boesch M, Baty F, Bilz S, Brutsche MH, Rassouli F. Tracking Real-World Physical Activity in Chronic Obstructive Pulmonary Disease Over One Year: Results from a Monocentric, Prospective, Observational Cohort Study. Int J Chron Obstruct Pulmon Dis. 2024 Aug 27;19:1921-1929. doi: 10.2147/COPD.S469984. eCollection 2024.
- Lung Center, Cantonal Hospital St.GallenLink provided by the sponsor.
- Cantonal Hospital St. GallenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute exacerbations of COPD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.