Maximal Oxygen Uptake (VO2max) in Patients With COPD

NCT ID: NCT06257381

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-07-08

Brief 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 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD-patients

We 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

VO2max

Intervention Type: OTHER

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).

Matched healthy volunteers

We aim to include 16 healthy matched controls (sex +-3year age).

VO2max

Intervention Type: OTHER

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).

Interventions

VO2max

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).

Intervention Type: OTHER

Other Intervention Names

Lung function test

Eligibility Criteria

Inclusion Criteria

• 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%

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Milan Mohammad

Medical student (BS.c.) at Department of Physical Activity Research Center, Rigshospitalet, Principal Investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, København Ø, Denmark

Countries

Denmark

Other Identifiers

H-23075064

Identifier Type: -

Identifier Source: org_study_id