Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830306
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2021-03-31
Brief Title:
Step Walk Bike Comparisons of Fitness Assessments
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Comparison of Submaximal Exercise Tests With Maximal Exercise Test
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ie prisoner
Diagnosed history of dementia
Inability to ambulate independently
Considered inappropriate to participate by Principal Investigator
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 ie prisoner
Diagnosed history of dementia
Inability to ambulate independently
Considered inappropriate to participate by Principal Investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None