| 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
|
|
|
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
|
|
|
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 - To determine normative values for Unsupported Upper Limb Exercise Testing in urban Indian males aged 18–75 years.
Secondary Objectives - To compare values of UULEX between different age groups.
- 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 - - Chair without arm support
- Blood pressure machine
- Pulse oximeter
- Wooden barbell weights 0.2 kg, 0.5 kg, 1 kg, 1.5 kg, 2 kg
- Stop watch or timer
- Borg scale
- Banner
- Metronome app
Inclusion Criteria - - Urban male population
- Age group 18–75 years
Exclusion Criteria - - Individual with history of smoking
- Individual with cardiovascular, pulmonary, or neurological conditions
- Individual with orthopedic conditions affecting upper limbs or recent upper limb surgery
- 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 - - Age, height, weight, BMI
- 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 - - Start with 0.5 kg bar at level 1
- Progress through levels 1 to 8 with metronome guidance
- Increase weight gradually up to 2 kg
- 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 |