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CTRI Number  CTRI/2025/10/095674 [Registered on: 07/10/2025] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Normal Values of the Unsupported Upper Limb Exercise Test (UULEX) to understand upper limb endurance in the Urban Indian Female Population in the Age group of 18–75 Years 
Scientific Title of Study   Normative Values of the Unsupported Upper Limb Exercise Test (UULEX) in the Urban Indian Female Population in the Age group of 18–75 Years: A Cross-Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meeti Mehta 
Designation  Post Graduate Student 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy, Navi Mumbai 
Address  D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09167014790  
Fax    
Email  meetimehta01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anuprita Thakur  
Designation  Professor And Head, Dept Of Cardiovascular and Pulmonary Physiotherapy, School of Physiotherapy 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy, Navi Mumbai 
Address  D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, School pf Phyiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9820132985  
Fax    
Email  anuprita.thakur@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Meeti Mehta 
Designation  Post Graduate Student 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy, Navi Mumbai 
Address  D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai


MAHARASHTRA
400706
India 
Phone  09167014790  
Fax    
Email  meetimehta01@gmail.com  
 
Source of Monetary or Material Support  
D.Y.Patil deemed to be university , School of Physiotheraphy , Navi Mumbai- 400706  
 
Primary Sponsor  
Name  School Of Physiotherapy  
Address  D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai - 400706 
Type of Sponsor  Private medical college 
 
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 
Meeti Mehta  D.Y. Patil deemed to be a University, School of Physiotherapy, Navi Mumbai  D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 
09167014790

meetimehta01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Individuals  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1.Healthy female population
2. Age group of 18 to 75 years
 
 
ExclusionCriteria 
Details  1. Individuals with a history of smoking
2. Individuals with cardiovascular, pulmonary, and neurological conditions
3. Individuals with orthopedic conditions affecting the upper limbs and/or any recent upper limb surgery
4. Individuals involved in regular exercise programs (e.g., athletes and sports persons)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine normative values for the Unsupported Upper Limb Exercise Test (UULEX) in the urban Indian female population in the age group of 18 75 years.

 
4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare values of the Unsupported Upper Limb Exercise Test (UULEX) between different age groups.
- To compare Unsupported Upper Limb Exercise Test (UULEX) values amongst different body mass index (BMI) categories.
 
4 months 
 
Target Sample Size   Total Sample Size="331"
Sample Size from India="331" 
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)   20/10/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Normative Values of the Unsupported Upper Limb Exercise Test (UULEX) in the Urban Indian Female Population in the Age Group of 18–75 Years: A Cross-Sectional Study.

Need of the Study:

This study is crucial to develop normative values for the Unsupported Upper Limb Exercise Test (UULEX) that are specific to the Indian population, as current data primarily originate from non-Indian populations and do not reflect India’s distinctive demographic, cultural, and occupational diversity. Upper limb endurance is essential for completing daily tasks, notably in a nation with various physical demands across urban and rural areas. This is particularly important for individuals with conditions that influence upper limb endurance, such as COPD, where unsupported arm movements often result in considerable dyspnea and fatigue. The lack of population-specific normative values restricts the effective application of UULEX in assessing functional limitations and devising rehabilitation strategies for these individuals in Indian clinical contexts. This study aims to offer culturally and demographically relevant benchmarks, allowing clinicians to precisely assess upper limb endurance, for instance, in patients with conditions like COPD.

Aim:

To establish normative values for Unsupported Upper Limb Exercise Test (UULEX) in Urban Indian Females in the Age group of 18–75 years

Objectives:

Primary Objective:
- To determine normative values for the Unsupported Upper Limb Exercise Test (UULEX) in the Urban Indian Female Population in the age group of 18–75 years.

Secondary Objectives:
- To compare values of the Unsupported Upper Limb Exercise Test (UULEX) between different age groups.
- To compare Unsupported Upper Limb Exercise Test (UULEX) values amongst different body mass index (BMI) categories.

Materials and Methodology

Study Details:

  • Study Setting – D.Y. Patil deemed to be University, School of Physiotherapy, Navi Mumbai
  •  Study Design – Cross-sectional study
  •  Study Duration – 4 months
  •  Study Participants/Subjects—Healthy female population
  • Sample Size—331
  •  Sampling Procedure – Not explicitly mentioned, but likely convenience sampling

Inclusion Criteria

  1. Healthy female population
  2. Age group of 18–75 years

Exclusion Criteria

  1. Individuals with a history of smoking
  2. Individuals with cardiovascular, pulmonary, and neurological conditions
  3. Individuals with orthopedic conditions affecting the upper limbs and/or any recent upper limb surgery
  4. Individuals involved in regular exercise programs (e.g., athletes and sportspeople)

 

Outcome Measures:

The primary outcome measure in this study is the time taken to complete the UULEX test, based on the participant stopping the activity due to upper limb fatigue, as assessed using the Borg scale.

Plan of the study:

1. Approval for conducting the study will be obtained from the Institutional Ethics Committee (IEC) for Biomedical and Health Research at Dr. D. Y. Patil Medical College & Hospital, Navi Mumbai.

2. The study will include healthy urban Indian females aged 18-75 years.

3. Participants will be selected based on the inclusion and exclusion criteria.

4. Subjects willing to participate will be asked to fill out a consent form, confirming their willingness and approval to participate in the study.

5. Participants will be informed about the UULEX test, including its purpose and significance.

6. Demographic data such as age and BMI will be recorded before proceeding with the test.

7. Pre-test measurements, including Respiratory Rate (RR), Blood Pressure (BP), Heart Rate (HR), and Rate of Perceived Exertion (RPE) will be recorded.

8. The patient will be seated on a chair with arms unsupported, facing the wall where the chart will be placed.

9. A two-minute warm-up will be performed using a 0.2 kg bar at level 1.

10. The test will begin with a 0.5 kg bar at level 1, following a metronome pace of 30 beats per minute for one minute.

11. At the end of the minute, the subject will progress to level 2 while maintaining the same weight.

12. This will be continued incrementally up to level 8.

13. After reaching level 8, the subject will restart from level 1 with an increased bar weight of 1 kg (an additional 500 g).

14. The same procedure will be followed, with the weight increasing progressively in 500 g increments until a maximum of 2 kg is reached.

15. The test will conclude when the subject is unable to continue due to fatigue, which will be measured using the Borg Scale.

16. The total time taken to complete the test will be recorded in minutes/seconds.

17. Post-test measurements, including Respiratory Rate (RR), Blood Pressure (BP), Heart Rate (HR), and Rate of Perceived Exertion (RPE), will be recorded.

18.  The collected data will be categorized according to age, i.e., young adulthood, middle adulthood and old adulthood

19. Statistical analysis will be performed to obtain normative values.

20. The results will be analyzed, and time taken will be compared with age and BMI.

                                                   

 


 
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