NCT05719571

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 31, 2023

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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.

    1 Day

  • Pulse Rate

    Beat per minute it is measured through Pulse Oximeter

    1 Day

  • Oxygen Saturation

    It is measured in percentage of Oxygen in tissue, measured through Pulse oximeter

    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

    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

    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

    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

    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

    1 Day

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Male and female aged between 18-35 years
  • Individuals with normal BMI i.e. 18.5-24.9
  • Individuals with positive cardiovascular family history

You may not qualify if:

  • Subjects with any known cardiovascular \& pulmonary disease
  • Subjects addicted to caffeine/ smoking
  • Subjects with any neuromuscular disability/deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital, Pakistan

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Anam Aftab, PPDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

August 18, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

February 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations