| CTRI Number |
CTRI/2026/01/101940 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| 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
|
The effect of breathing exercises and aerobics on fitness and health in less active overweight women. |
|
Scientific Title of Study
|
The effect of inspiratory muscle training along with aerobic exercises
on physical fitness and quality of life in overweight sedentary women:
Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annaglory Augustin Janwadkar |
| Designation |
Postgraduate student in department of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of cardiovascular and respiratory physiotherapy, OPD F17, Maharashtra Institute Of Physiotherapy, Latur, MIMSR Campus,Ambajogai Road ,Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
9529591694 |
| Fax |
|
| Email |
annagloryjanwadkar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Kumar |
| Designation |
Associate Professor in department of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of cardiovascular and respiratory physiotherapy, OPD F17, Maharashtra Institute Of Physiotherapy, Latur, MIMSR Campus,Ambajogai Road ,Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
8825359796 |
| Fax |
|
| Email |
pawanphysio43100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pawan Kumar |
| Designation |
Associate Professor in department of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of cardiovascular and respiratory physiotherapy, OPD F17, Maharashtra Institute Of Physiotherapy, Latur, MIMSR Campus,Ambajogai Road ,Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
8825359796 |
| Fax |
|
| Email |
pawanphysio43100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Latur-413531 |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Latur-413531 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Annaglory Janwadkar |
Maharashtra Institute of Physiotherapy, Latur |
Department of Cardiovascular and respiratory physiotherapy, OPD-17, Maharashtra Institute of Physiotherapy, Latur, MIMSR capmus, Ambejogai Road, Latur-413531
Latur
MAHARASHTRA |
9529591694
annagloryjanwadkar01@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AEROBIC EXERCISE |
Aerobic Exercises like treadmill walking and cycling frequency of 3 times per week for 6 weeks
duration 20 to 60 minutes per session including warmup and cooldown exercises and intensity till RPE 11 to 13 |
| Intervention |
Inspiratory muscle training along with aerobic exercise |
inspiratory muscle training using IMT device, starting with the resistance of the 40% and then increasing every 2 weeks and Aerobic Exercises like treadmill walking and cycling with frequency of 3 times per week for 6 weeks and
duration 20 to 60 minutes per session including warmup and cooldown exercises and intensity till RPE 11 to 13 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Individuals with the age of 20- 40 years
Individuals with the BMI of 23.0–24.9 kg/m2
Individuals those are willing to participate
Individuals who have rate of perceived exertion less than 13 on Borg scale |
|
| ExclusionCriteria |
| Details |
Individuals with a known case of respiratory and cardiovascular disorders
Individuals with musculoskeletal disorders about thorax and lower limbs
Individuals with any psychological disorders
Individuals who are involved in structured exercise program
Individuals performing activities MET value more than 6 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Physical fitness: VO2 max using queen’s college step test (r =1.0)
VO2 max(ml/Kg/min) = Women = 65.81 - (0.1847 x heart rate (bpm))
2.Quality of life using SF-36 |
1 BASELINE
2 END OF 6TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MAXIMUM INSPIRATORY PRESSSURE USING MANOMETER |
1 BASELINE
2 START OF 3RD WEEK
3 START OF 5TH WEEK
4 END OF 6TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
02/02/2026 |
| 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="1"
Months="0"
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 study is an experimental randomized controlled trial to evaluate the impact of combining inspiratory muscle training with aerobic activity over a 6 week period in overweight sedentary females
1 Participant Selection A total of 30 overweight sedentary women will be recruited for the study based on specific eligibility requirements physical consent will be taken from the participants for the research Inclusion Criteria 1 Women aged 20 to 40 years 2 Body Mass Index (BMI) between 23.0 and 24.9 kg/m^2 (overweight for Asian populations) 3 Willingness to participate 4 rate of perceived exertion (Borg scale) of less than 13 5 maximum inspiratory pressure less than 80 cm H2O
Exclusion Criteria 1 Known respiratory or cardiovascular disorders 2 Musculoskeletal issues involving the thorax or lower limbs 3 Psychological disorders 4 Already participating in a structured exercise program or engaging in activities with a MET value greater than 3
2 Randomization After an initial pre-evaluation, eligible participants will be randomly assigned into two groups using simple random sampling Group A (Experimental Group) 33 participants receiving combined training Group B (Control Group) 34 participants receiving aerobic exercise only
3 Intervention Protocol Both groups will follow a protocol for 3 days per week for 6 weeks. Each session lasts 20 to 60 minutes and includes a 5 to 10 minute warm-up and a 5–10 minute cool-down Group A (Experimental) Aerobic and Inspiratory Muscle Training (IMT) Aerobic usingTreadmill training and static cycling IMT Using a threshold device for 3 series of 10 repetitions with 2minute intervals. Resistance starts at 40% of Maximum Inspiratory Pressure (MIP) in week 1 and increasing gradually by week 3 and week 5 Group B (Control): Aerobic Exercise Only Participants will perform the same aerobic conditioning (treadmill and cycling)
4 Outcome Measures Participants will be assessed at the start (Day 1) and at the end of the 6th week Physical Fitness (Primary) Measured by VO2 max using the Queens College Step Test which calculates cardiovascular endurance based on recovery heart rate Quality of Life (Primary) Evaluated using the SF-36 questionnaire Inspiratory muscle Strength (secondary) using Maximum Inspiratory Pressure (MIP) will also be recorded to track improvements in inspiratory muscle strength |