HealthyNCT05719571
Measurement of Maximal Oxygen Uptake (VO2max) Using Mankato Submaximal Exercise Test in Young Adults
An observational study of Healthy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To measure the maximal oxygen uptake (VO2max) using Mankato Submaximal Exercise test. To correlate 'true' VO2max with Modified Bruce protocol and Mankato Submaximal Exercise Test. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Aug 2020to 31 Oct 2020
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: study design was Analytical (Correlational) study design. During the first visit, First of all, 'true' VO2max of all subjects was calculated using non-exercise regression equation and one mile walk test. On the 2nd visit, the participants performed Modified Bruce Submaximal Exercise test depending upon their fitness level and Mankato Submaximal Exercise test in counter balanced order with 30 minutes rest in between.
Who may be able to join
- Male and female aged between 18-35 years
- Individuals with normal BMI i.e. 18.5-24.9
- Individuals with positive cardiovascular family history
Who cannot join
- Subjects with any known cardiovascular \& pulmonary disease
- Subjects addicted to caffeine/ smoking
- Subjects with any neuromuscular disability/deformity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Railway General Hospital, Pakistan
Rawalpindi, Punjab Province, 46000
About this study
- To measure the maximal oxygen uptake (VO2max) using Mankato Submaximal Exercise test.
- To correlate 'true' VO2max with Modified Bruce protocol and Mankato Submaximal Exercise Test.
Read the detailed description
First of all, 'true' VO2max of all subjects was calculated using non-exercise regression equation and one mile walk test. Variables used for the VO2max regression equation included BMI, age (years), gender (Male=1, Female=0) and physical activity rating scale. On the same visit, the subjects also performed one mile walk test. After the completion of test, pulse rate of subjects was calculated in beats per minute. The VO2max after the test was measured using the VO2max aerobic capacity calculator. Variables required were age, gender, weight, total time taken to complete test and pulse rate at test completion.
'True' VO2max accepted was the highest value obtained from non-exercise regression equation and one mile walk test On the 2nd visit, the participants performed Modified Bruce Submaximal Exercise test depending upon their fitness level and Mankato Submaximal Exercise test in counter balanced order with 30 minutes rest in between
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
PAR Scale
PAR scale is a self reported physical activity rating scale used for a healthy population. It describes the physical activity level of an individual from the last 6 months. It consists of scale from 0-15.
Measured: 1 Day
Pulse Rate
Beat per minute it is measured through Pulse Oximeter
Measured: 1 Day
Oxygen Saturation
It is measured in percentage of Oxygen in tissue, measured through Pulse oximeter
Measured: 1 Day
One Mile Walk Test
One mile walk test is also termed as Rockport Fitness Walking Test. The subject walk distance of 1 mile and take record of the time took to cover that distance. The subject's pulse rate is taken after the completion of test by pulse oximeter
Measured: 1 Day
VO2max Aerobic Capacity Calculator
VO2max aerobic capacity calculator is an online calculator used to measure VO2max. It calculates VO2max using the four most common methods which include, VO2max based on resting heart rate, VO2max based on one mile walk test, VO2max based on three minute step test and VO2max based on 1.5 mile walk or run test
Measured: 1 Day
Non-Exercise Regression Equation
Non-exercise regression equation is used for measuring VO2max based on non-exercise data. The variables required for the following equation are PAR scale, age, BMI and gender.
VO2max (ml/kg/min) = 56.363 + 1.921 × PAR - 0.381 × Age - 0.754 × BMI + 10.987 × Gender
Measured: 1 Day
Metabolic Equations
ACSM metabolic equations are used for measuring VO2max. These metabolic equations are mentioned in ACSM's Guidelines for Exercise Testing and Prescription 2018. Following metabolic equations are used:
- Speak (m.min-1) = (VO2max - 3.5) ∕0.2
- Running VO2max (ml/kg/min) = (0.1 × speed) + (1.8 × speed × grade) + 3.5
- Walking VO2max (ml/kg/min) = (0.2 × speed) + (0.9 × speed × grade) + 3.5
Measured: 1 Day
Modified Bruce protocol
Modified Bruce protocol is a treadmill protocol and modified form of Bruce protocol with decreased increment in initial stages and then increasing the slope progressively. Following are the Modified Bruce protocol stages:
Stage 0 = 1.7 mph at 0% Grade Stage 0.5 = 1.7 mph at 5% Grade Stage 1 = 1.7 mph at 10% Grade Stage 2 = 2.5 mph at 12% Grade Stage 3 = 3.4 mph at 14% Grade Stage 4 = 4.2 mph at 16% Grade Stage 5 = 5.0 mph at 18% Grade Stage 6 = 5.5 mph at 20% Grade Stage 7 = 6.0 mph at 22% Grade Stage 8 = 6.5 mph at 24% Grade
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start18 Aug 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719571
- Sponsor's protocol ID
- REC/00777 Komal
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Maximal Oxygen Uptake (VO2max) Using Mankato Submaximal Exercise Test in Young Adults
- ClinicalTrials.gov ID
- NCT05719571
- Acronym / sponsor ID
- REC/00777 Komal
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 9 Feb 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 measure the maximal oxygen uptake (VO2max) using Mankato Submaximal Exercise test.
- To correlate 'true' VO2max with Modified Bruce protocol and Mankato Submaximal Exercise Test.
Detailed description
First of all, 'true' VO2max of all subjects was calculated using non-exercise regression equation and one mile walk test. Variables used for the VO2max regression equation included BMI, age (years), gender (Male=1, Female=0) and physical activity rating scale. On the same visit, the subjects also performed one mile walk test. After the completion of test, pulse rate of subjects was calculated in beats per minute. The VO2max after the test was measured using the VO2max aerobic capacity calculator. Variables required were age, gender, weight, total time taken to complete test and pulse rate at test completion.
'True' VO2max accepted was the highest value obtained from non-exercise regression equation and one mile walk test On the 2nd visit, the participants performed Modified Bruce Submaximal Exercise test depending upon their fitness level and Mankato Submaximal Exercise test in counter balanced order with 30 minutes rest in between
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- study design was Analytical (Correlational) study design. During the first visit, First of all, 'true' VO2max of all subjects was calculated using non-exercise regression equation and one mile walk test. On the 2nd visit, the participants performed Modified Bruce Submaximal Exercise test depending upon their fitness level and Mankato Submaximal Exercise test in counter balanced order with 30 minutes rest in between.
Key inclusion criteria (3 listed)
- Male and female aged between 18-35 years
- Individuals with normal BMI i.e. 18.5-24.9
- Individuals with positive cardiovascular family history
Key exclusion criteria (3 listed)
- Subjects with any known cardiovascular \& pulmonary disease
- Subjects addicted to caffeine/ smoking
- Subjects with any neuromuscular disability/deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PAR Scale
Time frame: 1 Day
PAR scale is a self reported physical activity rating scale used for a healthy population. It describes the physical activity level of an individual from the last 6 months. It consists of scale from 0-15.
Pulse Rate
Time frame: 1 Day
Beat per minute it is measured through Pulse Oximeter
Oxygen Saturation
Time frame: 1 Day
It is measured in percentage of Oxygen in tissue, measured through Pulse oximeter
One Mile Walk Test
Time frame: 1 Day
One mile walk test is also termed as Rockport Fitness Walking Test. The subject walk distance of 1 mile and take record of the time took to cover that distance. The subject's pulse rate is taken after the completion of test by pulse oximeter
VO2max Aerobic Capacity Calculator
Time frame: 1 Day
VO2max aerobic capacity calculator is an online calculator used to measure VO2max. It calculates VO2max using the four most common methods which include, VO2max based on resting heart rate, VO2max based on one mile walk test, VO2max based on three minute step test and VO2max based on 1.5 mile walk or run test
Non-Exercise Regression Equation
Time frame: 1 Day
Non-exercise regression equation is used for measuring VO2max based on non-exercise data. The variables required for the following equation are PAR scale, age, BMI and gender. VO2max (ml/kg/min) = 56.363 + 1.921 × PAR - 0.381 × Age - 0.754 × BMI + 10.987 × Gender
Metabolic Equations
Time frame: 1 Day
ACSM metabolic equations are used for measuring VO2max. These metabolic equations are mentioned in ACSM's Guidelines for Exercise Testing and Prescription 2018. Following metabolic equations are used: * Speak (m.min-1) = (VO2max - 3.5) ∕0.2 * Running VO2max (ml/kg/min) = (0.1 × speed) + (1.8 × speed × grade) + 3.5 * Walking VO2max (ml/kg/min) = (0.2 × speed) + (0.9 × speed × grade) + 3.5
Modified Bruce protocol
Time frame: 1 Day
Modified Bruce protocol is a treadmill protocol and modified form of Bruce protocol with decreased increment in initial stages and then increasing the slope progressively. Following are the Modified Bruce protocol stages: Stage 0 = 1.7 mph at 0% Grade Stage 0.5 = 1.7 mph at 5% Grade Stage 1 = 1.7 mph at 10% Grade Stage 2 = 2.5 mph at 12% Grade Stage 3 = 3.4 mph at 14% Grade Stage 4 = 4.2 mph at 16% Grade Stage 5 = 5.0 mph at 18% Grade Stage 6 = 5.5 mph at 20% Grade Stage 7 = 6.0 mph at 22% Grade Stage 8 = 6.5 mph at 24% Grade
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 9 Feb 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.
Anam Aftab, PPDPT principal investigator
Riphah International University
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 Healthy, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 3 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 9 Feb 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 Pakistan. 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?
PAR Scale (time frame: 1 Day). The study lists 8 primary outcomes in all. 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 9 Feb 2023.