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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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
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 groups in NCT04830306
Study groupRoleWhat they receive
6MSTActive comparatorSix minute step test
Receives: Behavioral: Exercise
6MWTActive comparatorSix minute walk test
Receives: Behavioral: Exercise
CPETActive comparatorCardiopulmonary exercise test
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted5 Apr 2021
  2. Study start6 Apr 2022
  3. Primary completion21 Sep 2022
  4. Study completion21 Sep 2022

Resources

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)
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

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.

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