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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  
Galgotias University 
 
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  
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 
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  
Status 
Not Applicable 
 
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.

 
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