| CTRI Number |
CTRI/2026/03/105663 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| 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
|
Effect of Box Breathing Exercise on Lung Function, Physical Fitness, Stress, and Sleep in Obese Adults with Early Breathing Problems |
|
Scientific Title of Study
|
Effect of Box Breathing on Cardiorespiratory Fitness, Lung Functions, Stress and Quality of Sleep of Obese Adults with Prodromal Respiratory Dysfunction: 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 |
Asmita Dujawara |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8770610248 |
| Fax |
|
| Email |
dujawara@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kamran Ali |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kamran Ali |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Asmita Dujawara |
| Address |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Asmita Dujawara |
Galgotias University |
Physiotherapy OPD E 004 Yamuna Expressway, Greater Noida Gautam Buddha Nagar UTTAR PRADESH |
8770610248
dujawara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity with mild pulmonary restriction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Box Breathing |
Box breathing 4-4-4-4 cycle (inhale-hold-exhale-hold)
5-10 min daily
4 weeks |
| Comparator Agent |
Control group |
Participants allocated to the control group will receive conventional lifestyle advice including general physical activity recommendations and sleep hygiene advice without any structured breathing intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Obese according to WHO criteria
Mild respiratory symptoms
Normal spirometry but with borderline reductions in lung volumes (suggestive of prodromal dysfunction)
Non-smokers
Willingness to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Diagnosed respiratory diseases
Cardiovascular or neuromuscular disorders
Smoking or alcohol dependence
Pregnancy
Current participation in any structured breathing or yoga program |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the impact of box breathing on pulmonary function parameter including forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate in obese adults
|
At baseline and after four weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of Box Breathing on exercise tolerance and functional capacity, as measured by standardized tests such as the Step test.
To assess the effect of Box Breathing on stress levels, using validated Perceived Stress Questionnaire (PSS).
To assess the effect of Box Breathing on sleep quality, using validated tools such as the Pittsburgh Sleep Quality Index (PSQI)
|
At baseline and after four weeks of intervention. |
|
|
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)
|
30/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/03/2026 |
| 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 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
|
Obesity is associated with early or
prodromal respiratory dysfunction, reduced cardiorespiratory fitness, increased
stress levels, and poor sleep quality, even before the onset of overt
respiratory disease. Simple, non-pharmacological breathing interventions may
help improve respiratory efficiency and autonomic balance in this population.
This randomized controlled trial aims to
evaluate the effect of box breathing, a structured slow breathing technique, on
cardiorespiratory fitness, lung function, stress levels, and quality of sleep
in
obese adults with prodromal respiratory dysfunction. Eligible participants will
be randomly allocated to either a box breathing intervention group or a control
group receiving conventional lifestyle advice.
The intervention group will practice box
breathing for a prescribed duration over a period of four weeks. Outcome
measures including peak expiratory flow rate, cardiorespiratory fitness
parameters, perceived stress, and sleep quality will be assessed at baseline
and after completion of the intervention. The findings of this study may help
establish box breathing as a simple, low-cost physiotherapy-based intervention
for early respiratory and cardiorespiratory dysfunction in obese adults. |