| CTRI Number |
CTRI/2025/11/097239 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| 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
|
Study to find out if breathing muscle exercises can improve balance and memory in overweight older adults. |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Balance, Cardiovascular fitness and Cognition on overall wellbeing among Obese Older Adults- A 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 Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. E004, Department of Physiotherapy, Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08077688928 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. E004, Department of Physiotherapy, Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08077688928 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yatesh Sharma |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No. E005, Department of Physiotherapy, Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09917564408 |
| Fax |
|
| Email |
sharmayatesh0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development cell, Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No. B-315,Galgotias University Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti Sharma |
Galgotias University |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
sharmayatesh0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Experimental) |
1 Participants in Group A underwent a structured IMT program for a specified period of time.
2 The program included aerobic training (walking), breathing training.
3 Participants received education sessions to enhance their understanding of the exercises, proper breathing techniques, and self-management strategies.
4 The IMT program aimed to improve participants balance, cardiovascular fitness and cognition.
5 Balance was targeted through IMT and Coherent breathing that gradually increased in intensity.
6 The progress of participants in Group A was regularly monitored and adjusted based on their individual response and capabilities.
|
| Comparator Agent |
Group B (Control) |
1 Participants in Group B did not receive any specific intervention related to pulmonary rehabilitation.
2 They were encouraged to continue with their usual daily activities and lifestyle without any additional guidance or exercise regimen.
3 The control group served as a comparison to evaluate the specific effects of the inspiratory muscle program administered to Group A.
4 Baseline measurements of age, BMI, height, weight, Patient history, demographic data, balance, cardiovascular fitness, and cognition were recorded for participants in Group B.
5 The control groups progress and any changes in their balance, cardiovascular fitness, and cognition were assessed at the same intervals as Group A.
6 Participants in Group B were allowed to seek standard medical care and follow any treatment plans prescribed by their healthcare providers.
7 They were informed about the studys objectives and advised to report any significant changes or concerns related to their health during the study period.
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index above 30
Ability to Understand and Follow Instructions
Stable Medical Condition
Willingness to Participate
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they meet any of the following criteria:
Unstable Cardiovascular Conditions
Severe Cognitive Impairment.
Severe Neurological or Musculoskeletal Conditions
Any Other Condition: Any other medical or psychological condition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognition Mini-Mental State Examination
Balance Berg Balance scale
|
Base line and then 8th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Balance Berg Balance scale
Wellbeing World Health Organigation-5 Quality of Life Index
|
Base line and then 8th week |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
21/11/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This randomized controlled trial explores the effect of Inspiratory Muscle Training on balance, cardiovascular fitness, and cognitive function, and its overall impact on the wellbeing of obese older adults. Aging and obesity often lead to weakened respiratory muscles, impaired balance, reduced cardiovascular efficiency, and cognitive decline, which collectively affect quality of life and functional independence. IMT, a simple and non-invasive breathing exercise that strengthens the inspiratory muscles, may help counter these effects by enhancing respiratory efficiency and oxygen delivery. The study aims to evaluate whether regular IMT can improve postural stability, increase cardiovascular endurance, and enhance cognitive performance, thereby promoting better overall wellbeing. Participants are divided into experimental and control groups to assess changes after the intervention period. Through this investigation, the study seeks to provide scientific evidence supporting the inclusion of IMT as an effective therapeutic and preventive strategy to enhance physical and cognitive health among obese older adults. |