Maximal Oxygen Uptake (VO2max) in Patients With COPD

COPD Clinical Trial

— COPD-MAX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257381
• Other study ID #: H-23075064
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: Milan Mohammad, MS.c
• Phone: 60162372
• Email: milan.mohammad.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion criteria - COPD patients

• 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%

Inclusion criteria - healthy controls

• 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 - COPD patients

• 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

Exclusion criteria - healthy controls

• 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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Denmark	Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark.	Copenhagen	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	End-expiratory lung volume at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	End-expiratory lung volume at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	End-expiratory lung volume at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	End-expiratory lung volume at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory capacity at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory capacity at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory capacity at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory capacity at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Respiratory rate at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Respiratory rate at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Respiratory rate at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Respiratory rate at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Tidal volume at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Tidal volume at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Tidal volume at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Tidal volume at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Arterial saturation at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Arterial saturation at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Arterial saturation at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Arterial saturation at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory time at GET between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Inspiratory time at GET between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Expiratory time at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Expiratory time at VO2peak between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Time constant (tau) from VO2 kinetic test between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Time constant (tau) from VO2 kinetic test between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Steady state gain from VO2 kinetic test between-day smallest real difference (SRD) in COPD vs. healthy controls		Measured at day 1 and day 2
Other	Steady state gain from VO2 kinetic test between-day coefficient of variance (CV) in COPD vs. healthy controls		Measured at day 1 and day 2
Primary	Between-day smallest real difference (SRD) for VO2 peak in COPD vs. healthy controls		Measured at day 1 and day 2
Primary	Between-day coefficient of variance (CV) for VO2 peak in COPD vs. healthy controls (co-primary)		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) Wmax in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day coefficient of variance (CV) Wmax in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) RER at VO2 peak in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day coefficient of variance (CV) RER at VO2 peak in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) Gas Exchange Threshold (GET) in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day coefficient of variance (CV) Gas Exchange Threshold (GET) in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) in Ventilatory reserve in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day coefficient of variance (CV) in Ventilatory reserve in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) and Between-day coefficient of variance (CV) in VE/VCO2 at GET in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day smallest real difference (SRD) in VE/VCO2 at GET in COPD vs. healthy controls		Measured at day 1 and day 2
Secondary	Between-day coefficient of variance (CV) in HR peak in COPD vs. healthy controls		Measured at day 1 and day 2