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CTRI Number  CTRI/2025/10/096644 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 19/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effects of Breathing and Group Exercise on Oxygen Levels and Daily Function in Older Adults 
Scientific Title of Study   Age-related effects of combined diaphragmatic breathing and group exercise on oxygen saturation (SpO2) and activities of daily living (ADL) in elderly adults  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namitha S  
Designation  Post graduate student  
Affiliation  Yenepoya physiotherapy college 
Address  6th floor, Physiotherapy department, Yenepoya Physiotherapy college, Naringana Mangalore Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7892816323  
Fax    
Email  namithasubbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  M R Shivakumar 
Designation  Associate Professor 
Affiliation  Yenepoya physiotherapy college 
Address  6th floor Physiotherapy department, Yenepoya Physiotherapy college, Naringana Mangalore Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448386457  
Fax    
Email  mrsivakumar@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  M R Shivakumar 
Designation  Associate Professor 
Affiliation  Yenepoya physiotherapy college 
Address  6th floor Physiotherapy department, Yenepoya Physiotherapy college, Naringana Mangalore Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448386457  
Fax    
Email  mrsivakumar@yenepoya.edu.in  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Namitha S 
Address  6th floor Physiotherapy department, Yenepoya Physiotherapy college, Naringana Mangalore Dakshina Kannada KARNATAKA 575018 India 
Type of Sponsor  Other [self] 
 
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 
Namitha S  Olavina Halli   ground floor geriatric department, room no. 3, kinya post Manglore-575023
Dakshina Kannada
KARNATAKA 		 7892816323

namithasubbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  OLD AGE PEOPLE 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  combined diaphragmatic breathing and group exercise  Participants will perform a structured group exercise program together with diaphragmatic breathing in a common area of the old-age home. Each session includes: 10 minutes warm-up (gentle mobility and breathing awareness) 10 minutes upper-limb active range-of-motion and functional movements 10 minutes lower-limb active range-of-motion and functional movements 10 minutes cool-down and stretching Diaphragmatic breathing (six progressive steps) will be integrated into the sessions for approximately 8–12 minutes, first taught separately and later incorporated into exercise and functional tasks. Session frequency: 3 times per week (on alternate days) Session length: 40–45 minutes Phase duration: 5 weeks (15 sessions) Supervision: One supervised session per week by the investigator, 2 sessions per week unsupervised practice supported by staff 
Comparator Agent  group exercise  Identical group exercise program as above (same warm-up, limb movements, cool-down) without diaphragmatic breathing instruction or integration. Session frequency: 3 times per week (on alternate days) Session length: 40–45 minutes Phase duration: 5 weeks (15 sessions) 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Should be able to provide informed consent and understand and follow instructions 
 
ExclusionCriteria 
Details  Serious cognitive problems that impacted speech or comprehension, as well as injuries or dysfunctions that prevented exercising 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
oxygen saturation and activities of daily living  oxygen saturation and ADL will be assessed at baseline, at (phase 1) 5th week and at 12th week from baseline.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2025 
Date of Study Completion (India) 28/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/01/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Elderly individuals often experience respiratory decline, which reduces oxygen saturation (SpO2) and limits their ability to perform activities of daily living (ADL). While group exercise can improve physical fitness, it may not adequately address specific respiratory challenges. Diaphragmatic breathing enhances respiratory efficiency, but it is rarely integrated into exercise programs.

According to studies, diaphragmatic breathing exercises boost oxygen saturation.  A study comparing the impact of group exercises, with and without diaphragmatic breathing, across various age groups and levels of impairment could offer valuable insights into the effectiveness of these interventions in elderly populations.

 
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