FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/038361 [Registered on: 01/12/2021] Trial Registered Prospectively
Last Modified On: 02/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of unsupported upper limb Vs lower limb aerobic training on respiratory muscle strength and endurance in healthy young adults. 
Scientific Title of Study   Effect of unsupported upper limb Vs lower limb aerobic training on respiratory muscle strength and endurance in healthy young adults. 
Trial Acronym  PImax PEmax MVV VO2max 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siddhika Sanjay Kadam 
Designation  Postgraduate student 
Affiliation  Sancheti College of Physiotherapy 
Address  1st floor, cardiovascular and respiratory physiotherapy department, Sancheti Institute College of Physiotherapy, Thube park, Shivaji nagar

Pune
MAHARASHTRA
411005
India 
Phone  9819336265  
Fax    
Email  siddhikadam666@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prajakta Sahasrabudhe 
Designation  Associate professor Cardiovascular and Respiratory Physiotherapy 
Affiliation  Sancheti College of Physiotherapy 
Address  1st floor, Cardiovascular and Respiratory Physiotherapy department, Sancheti Institute College of Physiotherapy, Thube park, Shivaji Nagar

Pune
MAHARASHTRA
411005
India 
Phone  9930677920  
Fax    
Email  prajakta.sahasrabudhe2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Siddhika Sanjay Kadam 
Designation  Postgraduate student 
Affiliation  Sancheti College of Physiotherapy 
Address  1st floor, cardiovascular and respiratory physiotherapy department, Sancheti Institute College of Physiotherapy, Thube park, Shivaji nagar

Pune
MAHARASHTRA
411005
India 
Phone  9819336265  
Fax    
Email  siddhikadam666@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute College of Physiotherapy 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy 
Address  1st floor, Cardiovascular and Respiratory Physiotherapy department, Sancheti Institute College of Physiotherapy, Thube park, Shivaji Nagar, Pune 
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 Siddhika Kadam  Sancheti Hospital Institute for Orthopaedics and Rehabilitation  First floor, Cardiovascular and respiratory physiotherapy department, Sancheti Institute College of Physiotherapy, Thube park, Shivaji nagar, Pune
Pune
MAHARASHTRA 		 9819336265

siddhikadam666@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Both male and female healthy indiviuals with BMI less than 24.9 kg/m2 with age of 18 to 35 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lower limb aerobic training   Lower limb aerobic training will be given for 30 min for 3 days per week for 6 weeks 
Intervention  Unsupported upper limb aerobic training   Unsupported upper limb aerobic training will be given for 30 min for 3 days per week for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Individuals with total physical activity- MET minutes per week < 600
(according to GPAQ questionnaire) 
 
ExclusionCriteria 
Details  1.BMI > 24.9 kg/m2
2. Involved in any other fitness program.
3. Any cardiovascular disease.
4. Any orthopaedic injury.
5. Any neurological disease.
6. Any respiratory disease.
7. Pregnant women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Peak inspiratory pressure (PImax)
2. Peak expiratory pressure (PEmax)
3. Maximum Voluntary Ventilation (MVV)
4.Maximum exercise capacity (VO2 max) 		 Baseline and after 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2021 
Date of Study Completion (India) 10/07/2022 
Date of First Enrollment (Global)  05/12/2021 
Date of Study Completion (Global) 10/07/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a experimental study to see the effect of unsupported upper limb Vs lower limb aerobic training on respiratory muscle strength and endurance in healthy young adults. Pre and post intervention Peak inspiratory pressure (PImax) - for inspiratory muscle strength Peak expiratory pressure (PEmax) - for expiratory muscle strength using Micro RPM  device, Maximum Voluntary Ventilation (MVV) – for respiratory muscle endurance using spirometer and  Maximum exercise capacity (VO2 max) using shuttle walk test will be assessed then the subject will divide into two groups. Both the groups will receive either unsupported upper limb or lower limb aerobic training for 30 min for 3 times per week for 6 weeks.  
Close