| 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
|
|
|
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
|
|
|
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. |