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CTRI Number  CTRI/2025/06/089851 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of incremental shuttle walk test and modified shuttle walk test on walking distance in young adults  
Scientific Title of Study   Comparative analysis of incremental shuttle walk test and modified shuttle walk test on walking distance and ventilatory parameters in healthy young adult - A Randomized crossover trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Payal Sharma  
Designation  Postgraduate Student  
Affiliation  Datta Meghe college of physiotherapy,Nagpur  
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe college of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9503633176  
Fax    
Email  kmpssharma10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish P Shukla 
Designation  Professor 
Affiliation  Datta Meghe college of physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe college of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9960290614  
Fax    
Email  manish.shukla20@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Manish P Shukla 
Designation  Professor 
Affiliation  Datta Meghe college of physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe college of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9960290614  
Fax    
Email  manish.shukla20@gmail.com   
 
Source of Monetary or Material Support  
Datta Meghe college of Physiotherapy, Wanadongri Nagpur 441110 MAHARASHTRA India  
 
Primary Sponsor  
Name  Datta Meghe college of physiotherapy, 
Address  Shri Datta Meghe polytechnic campus, Wanadongri, Hingna road ,Nagpur 441110 MAHARSHTRA India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish P Shukla   Datta Meghe College of Physiotherapy   Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadonghri, Hingna road, Nagpur, 441110 MAHARASHTRA India
Nagpur
MAHARASHTRA 
9960290614

manish.shukla20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe College of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young healthy adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Incremental shuttle walk test  The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on an app. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres (i.e each time the patient reaches a cone is 1 shuttle). The results of the ISWT can be used to prescribe the intensity of walking training. Dose/frequency - Once ( no follow up ) Duration - until the patient feels to stop  
Comparator Agent  Modified shuttle walk test  The start of test and the speed of walking will be guided by a series of prerecorded signals played on a tape. The audio signal in the form of a triple beeps indicates when a subject should start a shuttle and another audio signal in the form of single bleep at the completion of a shuttle and giving an indication to the patient to turn around the cone. If the subject reached the cone before the signal, he/she will be instructed to wait until the signal indicated to proceed with the next shuttle. At the end of each minute of a level, there will be another triple bleep sound to mark the beginning of the next level. There will be no audio signal during the shuttle period to guide the patient how much time was left to complete the particular shuttle. Dose/frequency - Once ( no follow up ) Duration - until the patient feels to stop  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Subjects with sedentary lifestyle
2.Those who are willing to participate 
 
ExclusionCriteria 
Details  1.Subjects with episode of hypoglycaemia
2.Those with BP fluctuation
3.Subjects with recent lower limb fracture
4.Those having congenital cardiac condition or recently diagnosed condition
5.Those who are involved in any form of regular physical activity like gym or aerobics
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Distance covered (in m)

 
Same day after a flush out period of 30 to 60 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Rate of perceived exertion Borg scale (CR10)
2.Ventilatory parameters- SPO2
-Respiratory rate (RR)
-Heart rate (HR)
-Blood pressure (BP)
 
Same day after a flush out period of 30 to 60 minutes. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cardiorespiratory endurance, also known as aerobic fitness or aerobic capacity, is a critical aspect of overall physical fitness. It represents the ability of the body to perform large-muscle, whole-body physical activity at moderate to high intensity for prolonged periods. This component of fitness is closely tied to various health outcomes, particularly those related to body weight, obesity, and cardiometabolic risk factors. Given its significance to overall health and the feasibility of measurement, standardized field tests such as the 20-meter shuttle run have been widely adopted to evaluate cardiorespiratory endurance in younger populations.

One of the most widely used tests in both clinical and research settings to assess exercise capacity and ventilatory parameters is the Incremental Shuttle Walk Test (ISWT). The ISWT is a progressive, externally paced walking test that increases in difficulty over time and is particularly suited for evaluating functional capacity in individuals with chronic conditions such as chronic obstructive pulmonary disease (COPD) and heart failure. It has proven to be reliable and valid, with a strong correlation between walking distance and peak oxygen uptake (VO2 peak), which is a gold standard indicator of cardiorespiratory fitness. Furthermore, it is sensitive to therapeutic interventions, such as pulmonary rehabilitation and bronchodilator use, and is commonly used to track changes in exercise capacity over time.

A variation of the ISWT, the Modified Shuttle Walk Test (MSWT), is used to suit specific population groups or research objectives. While it follows the general structure of the ISWT, the MSWT may incorporate differences in pacing, cue signaling, or progression design. Both ISWT and MSWT serve as effective means to predict VO2 peak and assess the impact of various interventions on functional capacity. Given the increasing relevance of such tests in clinical and health monitoring scenarios, this study aims to evaluate and compare the effectiveness of ISWT and MSWT specifically in healthy young adults. The focus is on determining the differences and similarities in walking distance and ventilatory parameters when these tests are applied in a healthy population segment.

The aim of the study is to compare the walking distance and ventilatory parameters (such as heart rate, respiratory rate, oxygen saturation, and blood pressure) between ISWT and MSWT in healthy young adults. The study is designed to determine whether one test provides superior or more reliable measurements than the other, thereby informing future use in clinical, athletic, or general health settings. The objectives include measuring walking distance and ventilatory parameters following each of the two tests in the same population and subsequently comparing the results to evaluate any significant differences.

The methodology follows a randomized crossover trial design conducted across multiple departments at Datta Meghe Institute (including the Colleges of Physiotherapy, Medical, and Nursing). The study duration is 1.5 years, and it uses a convenient sampling technique with simple randomization. The estimated sample size for the study is 200, with 100 participants assigned to each group. This estimate was based on statistical parameters including a power of 80%, standard deviation of 0.97, and a correlation coefficient of 0.85 between the two test periods.

Inclusion criteria for participation include healthy young adults aged 18 to 25 years, individuals leading a sedentary lifestyle, and those who provide informed consent. Exclusion criteria are clearly defined to eliminate confounding health conditions. Individuals with hypoglycemia, fluctuating blood pressure, recent lower limb fractures, congenital or recently diagnosed cardiac conditions, respiratory diseases such as asthma, and those engaged in regular physical activity (such as gym or aerobics) are excluded. Additionally, individuals who do not agree to participate are not considered.

Materials used in the study include a flat, clear walking area measuring at least 10 meters in length, cones to mark the shuttle path, audio recordings to provide pacing signals, measuring tape, data collection sheets, a clipboard and pen, a pulse oximeter, blood pressure monitoring equipment, a chair for rest if needed, and the Borg CR10 scale for rating perceived exertion. The outcome measures for both ISWT and MSWT include the total distance walked (in meters), ratings of perceived exertion, and ventilatory parameters such as blood oxygen saturation (SpO2), respiratory rate, heart rate, and blood pressure.

The operational procedure for the ISWT involves the participant walking back and forth between two cones placed 9 meters apart (making a 10-meter shuttle path), in time with auditory beeps that gradually increase in frequency. The walking pace starts slow and becomes progressively faster each minute. The participant is instructed to walk for as long as possible until they are too breathless or unable to keep pace with the beeps. Each shuttle completed counts as 10 meters, and the total distance is recorded at the end of the test.

For the MSWT, the procedure is similar but with a slightly modified pacing and cueing system. Participants receive a triple beep at the beginning of each level and a single beep at the completion of each shuttle. If the participant reaches the cone before the beep, they must wait for the next signal to proceed. Unlike the ISWT, no real-time auditory cues are provided during each shuttle to indicate how much time remains. This small change may influence participant pacing and distance covered.

Data analysis is carried out using SPSS 23.0 (IBM Software) for Windows. Descriptive statistics are employed to summarize the demographics and test results, reported in terms of means, standard deviations, confidence intervals, or medians depending on the distribution. Normality is checked using the Kolmogorov-Smirnov test. To compare parameters between the two tests, a one-way repeated measures analysis of variance (ANOVA) is conducted. A p-value of less than 0.05 is considered statistically significant, indicating meaningful differences in performance or physiological responses between the two tests.

The expected outcome of this study is to determine whether ISWT or MSWT provides more accurate, consistent, or clinically useful data when applied to a healthy young adult population. These findings can be pivotal in choosing appropriate fitness assessment tools in different scenarios—be it preventive health screenings, clinical fitness evaluations, or research involving healthy individuals. Furthermore, understanding the differences in ventilatory responses and walking performance between these two commonly used tests can enhance the precision of exercise prescriptions and improve overall health assessments in youth.

In conclusion, this study will provide a critical comparison of the Incremental Shuttle Walk Test and Modified Shuttle Walk Test in healthy young adults, focusing on walking distance and ventilatory parameters. By utilizing a well-structured randomized crossover design and robust statistical analysis, the research aims to generate practical and clinically relevant findings. The insights gained will not only help refine testing protocols for this demographic but may also extend to wider populations in future research, clinical practice, and health promotion initiatives.

 
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