Maximal Oxygen Uptake (VO2max) in Patients With COPD

NCT06257381 | Completed

• 1 other identifier: H-23075064
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Reliability; Test-retest; VO2max

Outcome Measures

Primary Outcomes (2)

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

Secondary Outcomes (11)

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

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

  Measured at day 1 and day 2

Other Outcomes (28)

• End-expiratory lung volume at GET between-day smallest real difference (SRD) in COPD vs. healthy controls

  Measured at day 1 and day 2

• End-expiratory lung volume at GET between-day coefficient of variance (CV) in COPD vs. healthy controls

  Measured at day 1 and day 2

• End-expiratory lung volume at VO2peak between-day smallest real difference (SRD) in COPD vs. healthy controls

  Measured at day 1 and day 2

Study Arms (2)

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

Other: VO2max

Matched healthy volunteers

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

Other: VO2max

Interventions

VO2max 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).

Also known as: Lung function test

COPD-patients; Matched healthy volunteers

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Men and women
• 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
• years
• Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
• Same sex, age (± 3 years) as the COPD patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student (BS.c.) at Department of Physical Activity Research Center, Rigshospitalet, Principal Investigator.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: February 5, 2024
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

DK (1)