Oxygen ConsumptionNCT06113133
Assessment of Maximal Oxygen Uptake in Cardiac Rehabilitation
An observational study of Oxygen Consumption, run by VIA University College at 1 site in Denmark.
Trial summary
To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Consumption
- What is being tested?
- measurement of oxygen uptake
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2022to 31 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are adults with heart diseases such as ischemia, heart failure and after heart valve surgery
Who may be able to join
- participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included
Who cannot join
- heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Maximal Oxygen Uptake in Persons Enrolled in Exercise-based Cardiac Rehabilitation
To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. This plateau will be examined for the purpose of assessing VO2 max in persons enrolled in exercise-based cardiac rehabilitation. Furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau.
Heart disease and characteristics for all participants are obtained. Participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. This included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (BORG6-20).
Read the detailed description
Oxygen uptake is measured breath-by-breath by a cardiopulmonary exercise test (CPET), and oxygen and carbon dioxide sensors were calibrated before each test along with the flow sensor, there was calibrated with a 3-litre syringe.
To examine the primary aim, the incidence of a plateau in oxygen uptake was examined by comparing the moving average of the last 15 consecutive breaths with the penultimate 15 breaths and cut-offs at <50 ml and <100 ml of oxygen.
Secondary criteria; Respiratory exchange ratio (RER max), Rating of perceived exertion (BORG RPE max) and heart rate (HR max) are examined to determine if the participant performs the exercise test with a maximal effort to exertion. The respiratory exchange ratio (VCO2/VO2) using age-depending RER cut-offs; 1.10 for ages 40-59 years, 1.06 for ages 60-69 years and +70 years to determine if a maximal effort is provided. There are no recommendations for RER cut-off when participants are aged above 69 years. Therefore, they must reach the RER cut-off 1.06 to be evaluated as maximal effort.
The rating of perceived exertion using the BORG RPE 6-20 scale evaluation > 17 is considered maximal effort. The test was supervised by experienced physiotherapists, an in-house nurse supported if necessary, and a physician was available upon request. Participants and physiotherapists were blinded for VO2 max results from CPET. CPET gas exchange system was operated by an experienced researcher.
Maximal heart rate is rated as a maximal effort by cut-offs calculated as 208 - (0.7 x age in years) according to age group. Using respectively, > 92% and > 89% of the calculated HR max for the age group 40-59 years and the age groups 60-69 years and +70 years to consider maximal effort.
- Conditions
- Oxygen Consumption
- Being tested
- measurement of oxygen uptake
- Keywords
- Physical fitness, heart disease, oxygen consumption
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of oxygen uptakeDiagnostic test
oxygen uptake is obtained during a maximal exercise test
| Study group | Role | What they receive |
|---|---|---|
| Maximal oxygen uptake | Measurement of maximal oxygen uptake using < 50-millilitre and 100 millilitre oxygen as a cut-off Receives: Diagnostic Test: measurement of oxygen uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
Cardiopulmonary exercise test by Metalyzer 3B to determine maximal oxygen uptake measured in millimetre oxygen
Measured: Pretest is conducted at the first day in rehabilitation. Posttest is conducted when a participant finish rehabilitation or maximal 1 week after the end of the rehabilitation after 12-weeks
Secondary outcomes (3)
Respiratory exchange ratio
Respiratory exchange ratio is according to the production of carbon dioxide divided by oxygen uptake and is expressed numerically for example 1,05. The highest RER value in the last 1 minute of the test is considered the result
Measured: Respiratory exchange ratio is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
Ratio of perceived exertion
Ratio of perceived exertion is assessed using the BORG scale 6-20, where 20 is the highest score
Measured: The participants rate their perceived exertion immediately after CPET is finished at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
Maximal heart rate
Measurement of the heart rate expressed by beats per minute. The highest HR within the last 1 minute of the test is considered the result.
Measured: Heart rate is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ConsumptionStudies 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
- Other
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIA University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maribo, Professor, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113133
- Sponsor's protocol ID
- 9000035
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maximal Oxygen Uptake in Persons Enrolled in Exercise-based Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT06113133
- Acronym / sponsor ID
- 9000035
- Conditions
- Oxygen Consumption
- Keywords
- Physical fitness, heart disease, oxygen consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- VIA University CollegeUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Nov 2023 (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.
To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. This plateau will be examined for the purpose of assessing VO2 max in persons enrolled in exercise-based cardiac rehabilitation. Furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau.
Heart disease and characteristics for all participants are obtained. Participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. This included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (BORG6-20).
Detailed description
Oxygen uptake is measured breath-by-breath by a cardiopulmonary exercise test (CPET), and oxygen and carbon dioxide sensors were calibrated before each test along with the flow sensor, there was calibrated with a 3-litre syringe.
To examine the primary aim, the incidence of a plateau in oxygen uptake was examined by comparing the moving average of the last 15 consecutive breaths with the penultimate 15 breaths and cut-offs at <50 ml and <100 ml of oxygen.
Secondary criteria; Respiratory exchange ratio (RER max), Rating of perceived exertion (BORG RPE max) and heart rate (HR max) are examined to determine if the participant performs the exercise test with a maximal effort to exertion. The respiratory exchange ratio (VCO2/VO2) using age-depending RER cut-offs; 1.10 for ages 40-59 years, 1.06 for ages 60-69 years and +70 years to determine if a maximal effort is provided. There are no recommendations for RER cut-off when participants are aged above 69 years. Therefore, they must reach the RER cut-off 1.06 to be evaluated as maximal effort.
The rating of perceived exertion using the BORG RPE 6-20 scale evaluation > 17 is considered maximal effort. The test was supervised by experienced physiotherapists, an in-house nurse supported if necessary, and a physician was available upon request. Participants and physiotherapists were blinded for VO2 max results from CPET. CPET gas exchange system was operated by an experienced researcher.
Maximal heart rate is rated as a maximal effort by cut-offs calculated as 208 - (0.7 x age in years) according to age group. Using respectively, > 92% and > 89% of the calculated HR max for the age group 40-59 years and the age groups 60-69 years and +70 years to consider maximal effort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maximal oxygen uptake | – | Diagnostic Test: measurement of oxygen uptakeMeasurement of maximal oxygen uptake using < 50-millilitre and 100 millilitre oxygen as a cut-off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are adults with heart diseases such as ischemia, heart failure and after heart valve surgery
Key inclusion criteria (1 listed)
- participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included
Key exclusion criteria (1 listed)
- heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of oxygen uptakeoxygen uptake is obtained during a maximal exercise test | Diagnostic test | Maximal oxygen uptake |
Primary outcome
Maximal oxygen uptake
Time frame: Pretest is conducted at the first day in rehabilitation. Posttest is conducted when a participant finish rehabilitation or maximal 1 week after the end of the rehabilitation after 12-weeks
Cardiopulmonary exercise test by Metalyzer 3B to determine maximal oxygen uptake measured in millimetre oxygen
3 secondary outcomes
Respiratory exchange ratio
Time frame: Respiratory exchange ratio is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
Ratio of perceived exertion
Time frame: The participants rate their perceived exertion immediately after CPET is finished at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
Maximal heart rate
Time frame: Heart rate is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.
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 2 Nov 2023.
- 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.
Maribo, Professor study chair
University of Aarhus
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 Oxygen Consumption, run by VIA University College 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 1 inclusion and 1 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 2 Nov 2023. 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?
Maximal oxygen uptake (time frame: Pretest is conducted at the first day in rehabilitation. Posttest is conducted when a participant finish rehabilitation or maximal 1 week after the end of the rehabilitation after 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023.