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CTRI Number  CTRI/2025/11/097718 [Registered on: 19/11/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to find normal values of the Unsupported Upper Limb Test in Indian Men aged 18 to 75years.  
Scientific Title of Study   Normative values of the Unsupported Upper Limb Exercise Test (UULEX) in Urban Indian Male Population in 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  Rhea Badela 
Designation  Post Graduate Student 
Affiliation  D Y Patil Deemed to be University , School of Physiotherapy 
Address  DY Patil Deemed to be University School of Physiotherapy , Department of Cardiopulmonary Physiotherapy , 6th floor , Plot No. 2 , Sector 5 , Nerul , Navi Mumbai - 400706

Thane
MAHARASHTRA
400706
India 
Phone  9689895559  
Fax    
Email  rbadela9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuprita Thakur 
Designation  Professor and Head of Department of Cariovascular and Pulmonary Physiotherapy , School of Physiotherapy 
Affiliation  D Y Patil Deemed to be University , School of Physiotherapy 
Address  DY Patil Deemed to be University School of Physiotherapy , Department of Cardiopulmonary Physiotherapy , 6th floor , Plot No. 2 , Sector 5 , Nerul , Navi Mumbai - 400706

Thane
MAHARASHTRA
400706
India 
Phone  9820132985  
Fax    
Email  anuprita.thakur@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Rhea Badela 
Designation  Post Graduate Student 
Affiliation  D Y Patil Deemed to be University , School of Physiotherapy 
Address  DY Patil Deemed to be University School of Physiotherapy , Department of Cardiopulmonary Physiotherapy , 6th floor , Plot No. 2 , Sector 5 , Nerul , Navi Mumbai - 400706

Thane
MAHARASHTRA
400706
India 
Phone  9689895559  
Fax    
Email  rbadela9@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Deemed to be University, School od Physiotherapy , Navi Mumbai 
 
Primary Sponsor  
Name  School of Physiotherapy 
Address  DY Patil Deemed to be University School of Physiotherapy , Department of Cardiopulmonary 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 
Dr Anuprita Thakur   D Y Patil Deemed to be University , School of Physiotherapy  Department of Cardiopulmonary Physiotherapy , 6th floor , Plot No. 2 , Sector 5 , Nerul , Navi Mumbai - 400706 DY Patil Deemed to be University School of Physiotherapy , Department of Cardiopulmonary Physiotherapy , 6th floor , Plot No. 2 , Sector 5 , Nerul , Navi Mumbai - 400706
Thane
MAHARASHTRA 
9820132985

rbadela9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Comm  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy male population 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1. Healthy male population.
2. Age group of 18-75 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 
The primary outcome measure in this study is the time taken to complete the UULEX Test , based on the participants stopping the activity due to upper limb fatigue , as assessed using the Borg scale.  One Time Assessment study  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   06/12/2025 
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="6"
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  

Introduction
Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease with extra pulmonary effects, primarily marked by progressive non reversible airflow limitation and abnormal inflammatory response to harmful particles. In India, its prevalence is about 5 percent in males and 2.7 percent in females above 30 years, with a male predominance. One of the early challenges in COPD is dyspnea during upper limb activities like bathing or dressing, as unsupported arm exercises demand more oxygen and cause greater fatigue. This is due to reduced muscle mass, increased ventilatory load, and diaphragm inefficiency.
The Unsupported Upper Limb Exercise Test (UULEX) is a symptom limited, incremental test to assess peak upper limb exercise capacity in individuals with COPD. It involves daily life like movements such as lifting, pushing, or reaching, making it a good tool to assess functional endurance. Establishing normative values for UULEX in urban Indian males aged 18–75 years will provide benchmarks for rehabilitation strategies and clinical assessment.


Aim - 
To establish normative values for Unsupported Upper Limb Exercise Testing in urban Indian males aged 18–75 years.


Objectives - 
Primary Objective

  1. To determine normative values for Unsupported Upper Limb Exercise Testing in urban Indian males aged 18–75 years.

Secondary Objectives

  1. To compare values of UULEX between different age groups.
  2. To compare UULEX values among different body mass index categories.


Study Design-Cross sectional study

Sample Size - 331

Study Duration - 6 months


Tools and Materials Used - 

  1. Chair without arm support
  2. Blood pressure machine
  3. Pulse oximeter
  4. Wooden barbell weights 0.2 kg, 0.5 kg, 1 kg, 1.5 kg, 2 kg
  5. Stop watch or timer
  6. Borg scale
  7. Banner
  8. Metronome app

Inclusion Criteria - 

  1. Urban male population
  2. Age group 18–75 years

Exclusion Criteria - 

  1. Individual with history of smoking
  2. Individual with cardiovascular, pulmonary, or neurological conditions
  3. Individual with orthopedic conditions affecting upper limbs or recent upper limb surgery
  4. Individuals engaged in regular exercise programs such as athletes and sports persons

Methodology - 
Participants fulfilling the inclusion criteria and willing to participate will be recruited. Written informed consent will be taken. The test technique will be explained in simple terms. Demographic details such as name, age, height, weight, and BMI will be recorded.


Demographic Assessment - 

  1. Age, height, weight, BMI
  2. Baseline vitals: respiratory rate, heart rate, blood pressure, Borg’s rate of perceived exertion

Warm up - Two minutes using 0.2 kg bar at level 1

Assessment Protocol - 

  1. Start with 0.5 kg bar at level 1
  2. Progress through levels 1 to 8 with metronome guidance
  3. Increase weight gradually up to 2 kg
  4. Continue until subject fatigue or voluntary cessation

Post Exercise Vitals - Respiratory rate, heart rate, blood pressure, Borg’s RPE

Outcome Measure - Total time in seconds taken to complete the test

 
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