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CTRI Number  CTRI/2026/02/103782 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative Study of Respiratory Muscle Training and Yogic Breathing on Lung Function and Exercise Capacity in the Elderly 
Scientific Title of Study   Comparative effects of respiratory muscle training versus yogic breathing on pulmonary function and endurance in older 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  Proprakash Yadav 
Designation  Post Graduate Student ( Master Of Physiotherapy) 
Affiliation  Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi-110070
South
DELHI
110070
India 
Phone  8826127091  
Fax    
Email  proprakashyadav8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rimsha Siddiqui 
Designation  Assistant Professor 
Affiliation  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi-110070
South
DELHI
110070
India 
Phone  9911288516  
Fax    
Email  rimsha.siddiqui@isiconline.org  
 
Details of Contact Person
Public Query
 
Name  Dr Rimsha Siddiqui 
Designation  Assistant Professor 
Affiliation  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, New Delhi-110070
South
DELHI
110070
India 
Phone  9911288516  
Fax    
Email  rimsha.siddiqui@isiconline.org  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, South Delhi-110070,India 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [] 
 
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 Rimsha Siddiqui  Indian Spinal Injuries Centre  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences,2nd floor, Sector-C, Vasant Kunj, South Delhi-110070
South
DELHI 
9911288516

rimsha.siddiqui@isiconline.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RESPIRATORY MUSCLE TRAINING AND FUNCTIONAL STRENGTH EXERCISES   RESPIRATORY MUSCLE TRAINING 1. Thoracic expansion , diaphragmatic breathing , segmental breathing 2. IMT (Intensity: 40–50% of maximal inspiratory pressure (MIP) Devices: Threshold inspiratory pressure loaders (e.g., POWER breathe) FUNCTIONAL STRENGTH EXERCISES a) Lower leg - 1. Toe raises (arm support) 2 x 10 reps  2. Toe raises (no arm support with 3 sec holds) 3. Heel raises (arm support) 2 x 10 reps 4. Heel raises (no arm support) 2 x 10 reps 5. Walk on toes 6. Walk on heels b) Upper leg - 1. Mini-squats 2 x 10 reps   2. Squats (arm support) 2 x 10 reps   3. Squats (no arm support) 10 reps 4. Step-ups (arm support) 2 x 10 reps   5. Step-ups (no arm support) 2 x 10 reps   6. Lateral step ups (arm support) 2 x 10 reps   7. Lateral step ups (no arm support) 2 x 10 reps c) Core strengthening on ball -   1. Sit on ball & hold 1 min   2. Sit and weight shift   3. Sit on ball & tap toes   4. Sit on ball & knee raise   5. Sit on ball & arm lifts   6. Sit on ball & move arms + legs  
Comparator Agent  YOGIC BREATHING AND REGULAR ACTIVITY   YOGIC BREATHING Warm-up 5 min (neck & shoulder rolls). Pranayama:– Dirgha Shwasan (3-part inhalation) 5 min.– Anulom-Vilom (alternate nostril) 10 min 6 breath /min. – Ujjayi with slight resistance 5 min. Thoraco-abdominal expansion: Tadasana with arm-lift, Trikonasana, Ardha-chakrasana, Bhujangasana, Setu-bandha; each 45-s hold × 2; progressed by increasing hold-time. Relaxation & humming (Bhramari) 5 min REGULAR ACTIVITY range of motion exercises 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age criteria more than equal to 60 years
2.Male and female
3.Patients who willing to participate in exercise programs
 
 
ExclusionCriteria 
Details  1.Morbid obesity ( class III obesity)
2.Major surgery
3.History of any cardiovascular, respiratory, neurological and musculoskeletal disorder.
4.No recent surgery (within 3 months)
5.Not involved in any extensive physical rehabilitation or exercise regime.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pulmonary function test
FEV1(forced expiratory volume in 1Second)
FVC(forced vital capacity)
MIP(maximal inspiratory pressure)
 
0 Session (Pre Test) And 20th Session (Post Test) 
 
Secondary Outcome  
Outcome  TimePoints 
Endurance (6 Minute Walk Test), Dyspnea (Modified Medical Research Council Scale)  0 Session (Pre Test) & 20th Session (Post Test) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   23/02/2026 
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="3"
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  

The geriatric population often experiences reduced physical capacity and muscle weakness due to ageing and chronic pulmonary conditions. Respiratory muscle training and yogic breathing are evidence based interventions that enhance respiratory efficiency functional independence and overall quality of life. Respiratory Muscle Strength Training strengthens the diaphragm and intercostal muscles and is beneficial for conditions such as chronic obstructive pulmonary disease asthma and respiratory muscle weakness. Yogic breathing through pranayama practices also improves respiratory function and supports better pulmonary health.

Regular yogic breathing strengthens respiratory muscles improves lung expansion and enhances forced vital capacity forced expiratory volume in one second peak expiratory flow rate and maximal voluntary ventilation. Techniques such as Bhastrika and Anulom Vilom act as endurance training for the diaphragm improving oxygen exchange and reducing airway resistance. Although both yogic breathing and respiratory muscle training independently improve respiratory function there is a lack of studies comparing their effectiveness in the geriatric population.

 

Study procedure

After baseline assessment and enrollment a total of forty older adults will be included in the study. Participants will be allocated into two groups an experimental group and a control group.

Participants allocated to the experimental group will receive a structured respiratory muscle training program. The program will include thoracic expansion exercises diaphragmatic breathing segmental breathing exercises and inspiratory muscle training. Inspiratory muscle training will be performed at an intensity of forty to fifty percent of maximal inspiratory pressure. The training protocol will be supervised and progressed as per individual tolerance.

Participants in the control group will undergo a yogic breathing and thoraco abdominal expansion program. The session will begin with a warm up consisting of neck rolls and shoulder rolls for five minutes. This will be followed by pranayama breathing exercises including Dirgha Shwasan for five minutes Anulom Vilom for ten minutes with a breathing rate of approximately six breaths per minute and Ujjayi breathing with slight resistance for five minutes.

Thoraco abdominal expansion will be achieved through yogic asanas including Tadasana with arm lift Trikonasana Ardha Chakrasana Bhujangasana and Setu Bandhasana. Each posture will be held for forty five seconds repeated twice and progressed by increasing the hold duration as tolerated. The session will conclude with relaxation and humming using Bhramari Pranayama for five minutes.

The total duration of each session for both groups will be approximately sixty minutes.

 

Statistical analysis plan

Descriptive statistics will be used to calculate mean and standard deviation for quantitative variables such as age height weight and body mass index. Frequency and percentage will be used for categorical variables such as gender.

Normality of data will be assessed using the Shapiro Wilk test. If the data is normally distributed the independent sample t test will be used to compare mean differences in pulmonary function parameters including forced expiratory volume in one second and forced vital capacity as well as pulmonary endurance measured by the six minute walk test between the two groups. The paired t test will be used to assess pre and post intervention differences within each group.

If the data is skewed the Mann Whitney U test will be used to compare differences between groups and the Wilcoxon signed rank test will be used to assess changes from pre to post intervention within groups.

Statistical analysis will be performed using SPSS version twenty one for Windows. Data will be managed and processed in Excel before being imported into SPSS.

 
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