Cardiorespiratory FitnessNCT04830306
Step, Walk, Bike: Comparisons of Fitness Assessments
A study testing Exercise in people with Cardiorespiratory Fitness, run by Duke University at 1 site in United States.
Trial summary
To compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST \& six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 21 Sep 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Able to speak English
- Ambulatory [assistive devices ok]
- Able to provide informed consent
Who cannot join
- Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
- Inmate of correctional facility (i.e. prisoner)
- Diagnosed history of dementia
- Inability to ambulate independently
- Considered inappropriate to participate by Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Comparison of Submaximal Exercise Tests With Maximal Exercise Test
To compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST \& six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET)
Read the detailed description
After enrollment, the subjects will complete each of the following CRF assessments:
Sub-maximal exercise test Six Minute Step Test (6MST): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. The subject will be given a standardized set of instructions on how to complete the test by raising each knee to 90 degrees of hip flexion. The total number of steps completed during the timed 6-minute period will be recorded.
Sub-maximal exercise test Six Minute Walk Test (6MWT): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. A 30-m unobstructed hallway with turning points marked with small cones will be used. The subject will be given a standardized set of instructions on how to complete the test. The total distance walked during the timed 6-minute period will be recorded.
Maximal exercise cardiopulmonary exercise test (CPET): The CPET is performed using an electromagnetically-braked cycle ergometer, 12-lead continuous ECG, continuous pulse oximetry, continuous expired gas analysis (oxygen and carbon dioxide) with ventilation [termed 'metabolic cart'] and intermittent non-invasive blood pressure measurement every 2 minutes. Once the subject is seated comfortably on the bike and adjusted for optimum cycling position, the face mask is fitted. The subjects are instructed on how to perform the incremental ramp test, starting with a baseline rest phase (no leg turnover) for 2 mins followed by reference phase of 2 mins of leg turnover with no resistance (0 watts). The incremental rise in work-rate from baseline is pre-determined by using the equation derived by Wasserman and colleagues in which the same work-rate is increased throughout the test to the limit of tolerance. A work-rate is selected by study staff to aim for a test duration of between 8 and 12 minutes. The subjects are instructed to maintain a cycling cadence of 55 - 65 revolutions per minute (rpm) during the exercise phase. One the limit of tolerance (maximal watts) is reached the resistance on the bike is removed () watts) and the subjects are encouraged to continue cycling for a further 2 mins during the recovery phase.
The order in which 6MST and 6MWT are performed will be randomized. Between test the subjects will be allowed to rest in a chair until the heart rate is within 5 beats per min of resting values and blood pressure in within 10 mmHg of resting values. The CPET will be conducted once both 6MWT and 6MST have been completed. If the subject expresses fatigue after either 6MWT and 6MST, then the subject may elect to re-attend on a separate day to complete the evaluation. At completion of exercise evaluations the subjects will be discharged from study participation. No further follow up will be performed.
Up to 40 subjects aged 18 or older will be enrolled.
Inclusion Criteria:
- Age 18 and older
- Able to speak English
- Ambulatory [assistive devices ok]
- Able to provide informed consent
Exclusion Criteria:
- Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
- Inmate of correctional facility (i.e. prisoner)
- Diagnosed history of dementia
- Inability to ambulate independently
- Considered inappropriate to participate by Principal Investigator
- Conditions
- Cardiorespiratory Fitness
- Being tested
- Exercise
- Keywords
- aerobic power, CPET, CPEX, cardiopulmonary exercise testing, exercise capacity, functional capacity, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Completion of exercise in accordance with assigned protocol
| Study group | Role | What they receive |
|---|---|---|
| 6MST | Active comparator | Six minute step test Receives: Behavioral: Exercise |
| 6MWT | Active comparator | Six minute walk test Receives: Behavioral: Exercise |
| CPET | Active comparator | Cardiopulmonary exercise test Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of oxygen consumed per minute as measured by wearable face mask
Oxygen measured in mL/min
Measured: Up to 15 minutes
Secondary outcomes (1)
Total amount of respiratory ventilation per minute as measured by wearable face mask
Respiratory ventilation measured in liters per minute
Measured: Up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start6 Apr 2022
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All subjects will be asked to complete the three exercise tests
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David MacLeod, FRCA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830306
- Sponsor's protocol ID
- Pro00108027
- Status last verified
- Nov 2021
- First submitted
- 31 Mar 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Submaximal Exercise Tests With Maximal Exercise Test
- ClinicalTrials.gov ID
- NCT04830306
- Acronym / sponsor ID
- Pro00108027
- Conditions
- Cardiorespiratory Fitness
- Keywords
- aerobic power, CPET, CPEX, cardiopulmonary exercise testing, exercise capacity, functional capacity, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 5 Apr 2021 (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 compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST \& six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET)
Detailed description
After enrollment, the subjects will complete each of the following CRF assessments:
Sub-maximal exercise test Six Minute Step Test (6MST): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. The subject will be given a standardized set of instructions on how to complete the test by raising each knee to 90 degrees of hip flexion. The total number of steps completed during the timed 6-minute period will be recorded.
Sub-maximal exercise test Six Minute Walk Test (6MWT): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. A 30-m unobstructed hallway with turning points marked with small cones will be used. The subject will be given a standardized set of instructions on how to complete the test. The total distance walked during the timed 6-minute period will be recorded.
Maximal exercise cardiopulmonary exercise test (CPET): The CPET is performed using an electromagnetically-braked cycle ergometer, 12-lead continuous ECG, continuous pulse oximetry, continuous expired gas analysis (oxygen and carbon dioxide) with ventilation [termed 'metabolic cart'] and intermittent non-invasive blood pressure measurement every 2 minutes. Once the subject is seated comfortably on the bike and adjusted for optimum cycling position, the face mask is fitted. The subjects are instructed on how to perform the incremental ramp test, starting with a baseline rest phase (no leg turnover) for 2 mins followed by reference phase of 2 mins of leg turnover with no resistance (0 watts). The incremental rise in work-rate from baseline is pre-determined by using the equation derived by Wasserman and colleagues in which the same work-rate is increased throughout the test to the limit of tolerance. A work-rate is selected by study staff to aim for a test duration of between 8 and 12 minutes. The subjects are instructed to maintain a cycling cadence of 55 - 65 revolutions per minute (rpm) during the exercise phase. One the limit of tolerance (maximal watts) is reached the resistance on the bike is removed () watts) and the subjects are encouraged to continue cycling for a further 2 mins during the recovery phase.
The order in which 6MST and 6MWT are performed will be randomized. Between test the subjects will be allowed to rest in a chair until the heart rate is within 5 beats per min of resting values and blood pressure in within 10 mmHg of resting values. The CPET will be conducted once both 6MWT and 6MST have been completed. If the subject expresses fatigue after either 6MWT and 6MST, then the subject may elect to re-attend on a separate day to complete the evaluation. At completion of exercise evaluations the subjects will be discharged from study participation. No further follow up will be performed.
Up to 40 subjects aged 18 or older will be enrolled.
Inclusion Criteria:
- Age 18 and older
- Able to speak English
- Ambulatory [assistive devices ok]
- Able to provide informed consent
Exclusion Criteria:
- Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
- Inmate of correctional facility (i.e. prisoner)
- Diagnosed history of dementia
- Inability to ambulate independently
- Considered inappropriate to participate by Principal Investigator
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All subjects will be asked to complete the three exercise tests
| Arm | Type | Receives |
|---|---|---|
| 6MST | Active comparator | Behavioral: ExerciseSix minute step test |
| 6MWT | Active comparator | Behavioral: ExerciseSix minute walk test |
| CPET | Active comparator | Behavioral: ExerciseCardiopulmonary exercise test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- Able to speak English
- Ambulatory [assistive devices ok]
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
- Inmate of correctional facility (i.e. prisoner)
- Diagnosed history of dementia
- Inability to ambulate independently
- Considered inappropriate to participate by Principal Investigator
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 |
|---|---|---|
| ExerciseCompletion of exercise in accordance with assigned protocol | Behavioural | 6MST, 6MWT, CPET |
Primary outcome
Total amount of oxygen consumed per minute as measured by wearable face mask
Time frame: Up to 15 minutes
Oxygen measured in mL/min
1 secondary outcome
Total amount of respiratory ventilation per minute as measured by wearable face mask
Time frame: Up to 15 minutes
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 5 Oct 2022.
- 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.
David MacLeod, FRCA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiorespiratory Fitness, run by Duke University at 1 site in United States.
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 4 inclusion and 5 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 5 Oct 2022. 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 United States. 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?
Total amount of oxygen consumed per minute as measured by wearable face mask (time frame: Up to 15 minutes). 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 5 Oct 2022.