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COPDCOPD-MAXNCT06257381

Maximal Oxygen Uptake (VO2max) in Patients With COPD

An observational study of COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with chronic obstructive pulmonary disease (COPD), facing a decline in lung function and compromised quality of life, often benefit from regular exercise (1). Assessing their cardiorespiratory fitness through maximal oxygen uptake (VO2max) is crucial (2), yet research on its validity and reliability in COPD… Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
COPD
What is being tested?
VO2max
Type of treatment
Pill or oral medicine
How many people
24 participants
Where
1 siteDenmark
Study dates
5 Feb 2024to 8 Jul 2024
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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be recruited through advertisements at pulmonary outpatient clinics and general practices in Greater Copenhagen, and by advertisements in newspapers, magazines, social media, and on forsøgsperson.dk as well as through forskningnu.dk. We have created a specific social media account which is used on different social medias to share knowledge and potentially recruit participants. It will not be possible to comment or tag people in our posts, and potentially interested participants will only be able to contact our research group via encrypted Region H mail. An e-mail address and telephone number will be provided by which interested participants can contact the research group.

Who may be able to join

  • Men and women
  • 45-80 years
  • COPD (GOLD stage I to IIII)
  • Forced expiratory volume in 1 sec (FEV1)/forced vital capacity ratio (FVC) < 0.8, FEV1 < 90% of predicted value.
  • Modified Medical Research Council score (mMRC 0 - 3)
  • Resting arterial oxygenation > 90%
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  • Men and women
  • 45-80 years
  • Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
  • Same sex, age (± 3 years) as the COPD patients

Who cannot join

  • Symptoms of ischaemic heart disease
  • Known heart failure
  • Claudication
  • Symptoms of disease within 2 weeks prior to the study
  • Participation in pulmonary rehabilitation within 6 months
  • Known malignant disease
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  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction
  • Known chronic lung disease
  • Known ischaemic heart disease
  • Known heart failure
  • Symptoms of disease within 2 weeks prior to the study
  • Known malignant disease
  • Claudication
  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark.

    Copenhagen, København Ø, 2100

Other trials in Denmark

About this study

Official title: Maximal Oxygen Uptake (VO2max) in Patients With COPD: a Test-Retest Reliability Study

Patients with chronic obstructive pulmonary disease (COPD), facing a decline in lung function and compromised quality of life, often benefit from regular exercise (1). Assessing their cardiorespiratory fitness through maximal oxygen uptake (VO2max) is crucial (2), yet research on its validity and reliability in COPD patients remains sparse. This study aims to fill this gap, examining the content validity and test-retest reliability of the VO2-max test in COPD, comparing it with healthy controls.

Read the detailed description

Introduction and background Patients with COPD face a challenging journey characterized by a progressive loss of lung function, ultimately resulting in a diminished quality of life, exercise limitations and heightened vulnerability to disability and premature mortality. Recognizing the pivotal role of regular exercise in enhancing the well-being of COPD patients, it becomes crucial to evaluate their cardiorespiratory fitness through parameters such as maximal oxygen uptake (VO2max). This metric serves as a cornerstone in assessing the maximal capacity of the cardiovascular system to deliver oxygen to working muscles and the muscles' ability to utilize oxygen during sustained exercise.

In broader health contexts high VO2max has been established as a key indicator inversely correlated with the risk of cardiovascular diseases and mortality. However, despite the acknowledged importance of VO2max, there is a notable gap in research focusing specifically on VO2max of COPD patients. The need for a thorough examination of the content validity of the VO2-max test in the context of COPD, along with an assessment of its test-retest reliability (day-to-day variation), has not been adequately addressed, especially in comparison with healthy individuals. While regular exercise has proven to be a transformative factor in improving the quality of life for COPD patients, there remains a critical need to explore the reliability of VO2-max testing within this population. Not only does COPD induce a decline in physical activity, but it can also contribute to a reduction in VO2-max. Consequently, understanding the validity and test-retest reliability of VO2-max testing in COPD becomes paramount.

Aim To compare the validity and test-retest reliability of the VO2-max test in COPD patients compared with healthy controls.

Perspective The results are relevant for designing future studies of VO2max and VO2kinetics as outcomes in COPD patients.

Conditions
COPD
Being tested
VO2max
Keywords
Reliability, Test-retest, VO2max
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VO2maxOther

    Also called Lung function test

    Overall design 16 non-smoking individuals with COPD and 16 controls (non-smokers) matched for age and sex on a group level will be included in the study. The study consists of two study days. Separation between the study days are at least 48 hours and maximum 10 days.

    Before entering the study: Informed written and oral consent.

    Study day 1: Medical examination, full lung function testing (dynamic spirometry, whole-body plethysmography, diffusion capacity) followed by a maximal oxygen consumption test (VO2peak), VO2-verification bout and VO2kinetic test (duration 3h).

    Study day 2: Participants will undergo a maximal oxygen consumption test (VO2peak), VO2-verification bout and VO2kinetic test (duration 1,5h).

Study groups in NCT06257381
Study groupRoleWhat they receive
COPD-patientsWe aim to include 16 patients with COPD across the FEV1% of predicted spectrum, ranging from mild to severe COPD. Participants will undergo lung function test and VO2max
Receives: Other: VO2max
Matched healthy volunteersWe aim to include 16 healthy matched controls (sex +-3year age).
Receives: Other: VO2max

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-day smallest real difference (SRD) for VO2 peak in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  2. Between-day coefficient of variance (CV) for VO2 peak in COPD vs. healthy controls (co-primary)

    Measured: Measured at day 1 and day 2

Secondary outcomes (11)

  1. Between-day smallest real difference (SRD) Wmax in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  2. Between-day coefficient of variance (CV) Wmax in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  3. Between-day smallest real difference (SRD) RER at VO2 peak in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  4. Between-day coefficient of variance (CV) RER at VO2 peak in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  5. Between-day smallest real difference (SRD) Gas Exchange Threshold (GET) in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  6. Between-day coefficient of variance (CV) Gas Exchange Threshold (GET) in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  7. Between-day smallest real difference (SRD) in Ventilatory reserve in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  8. Between-day coefficient of variance (CV) in Ventilatory reserve in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  9. Between-day smallest real difference (SRD) and Between-day coefficient of variance (CV) in VE/VCO2 at GET in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  10. Between-day smallest real difference (SRD) in VE/VCO2 at GET in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

  11. Between-day coefficient of variance (CV) in HR peak in COPD vs. healthy controls

    Measured: Measured at day 1 and day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start5 Feb 2024
  3. Primary completion8 Jul 2024
  4. Study completion8 Jul 2024

Resources

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
Case-control
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257381
Sponsor's protocol ID
H-23075064
Acronym
COPD-MAX
Status last verified
Jul 2024
First submitted
5 Feb 2024
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will be decided upon study completion.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 10 inclusion and 18 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 Jul 2024. 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 Denmark. 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?

Between-day smallest real difference (SRD) for VO2 peak in COPD vs. healthy controls (time frame: Measured at day 1 and day 2). The study lists 2 primary outcomes in all. 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 NCT06257381.

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 Jul 2024.

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