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CTRI Number  CTRI/2026/02/102809 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
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   Effect Of Combined Exercises Along With Controlled Breathing On Heart Lung Health, Immune Function And well-being In people living with HIV. 
Scientific Title of Study   Effect Of Concurrent Exercise Training Along With 4 Square Breathing On Cardiopulmonary Parameters, CD4 Cell Count And QOL In HIV-I Seropositive Individuals.A Randomised Clinical 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 Rachana Murkute 
Designation  Post Graduate student in department of Cardiovascular and Respiratory physiotherapy 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Department of cardiovascular and Respiratory physiotherapy,F-17, Maharashtra Institute Of Physiotherapy, MIMSR Campus,Ambajogai Road ,Latur 413531
Department of cardiovascular and Respiratory physiotherapy,F-17, Maharashtra Institute Of Physiotherapy, MIMSR Campus,Ambajogai Road ,Latur 413531
Latur
MAHARASHTRA
413531
India 
Phone  9359384417  
Fax  02382-227246  
Email  murkuterachana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishvnath Pawadshetty 
Designation  Professor and HOD 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Cardiovascular and respiratory physiotherapy department,F-17, Maharashtra Institute of Physiotherapy, MIMSR Medical College Campus, Vishwanathpuram, Ambajogai Road,Latur-413531

Latur
MAHARASHTRA
413531
India 
Phone  9422710990  
Fax  02382-227246  
Email  physiovish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishvnath Pawadshetty 
Designation  Professor and HOD 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Cardiovascular and Respiratory physiotherapy department, F-17, Maharashtra Institute of Physiotherapy, MIMSR Medical College Campus, Vishwanathpuram, Ambajogai Road, Latur-413531

Latur
MAHARASHTRA
413531
India 
Phone  9422710990  
Fax  02382-227246  
Email  physiovish@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra institute of physiotherapy Latur  
 
Primary Sponsor  
Name  Maharashtra Institute of Physiotherapy, Latur 
Address  Maharashtra Institute of Physiotherapy, Latur, MIMSR Medical Campus, Ambajogai Road ,Latur 413531 
Type of Sponsor  Private medical college 
 
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 
Dr Vishvnath S Pawadshetty  Happy Indian Village, (HIV Center)  Sevalaya balgriha,Hasegaon village, Ausa taluka, Latur Disrict, Maharashtra 413520
Latur
MAHARASHTRA 
9422710990

physiovish@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4 square breathing along with standard care   4 square breathing along with standard care like daily activities of the participants. 
Intervention  Concurrent Exercise training And 4 Square Breathing  Concurrent Exercises which include1.Aerobic Exercise and 2.Resistance Training along with 3. 4 Square Breathing. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Diagnosed with HIV-I seropositive
2.Age group 10-35 years
3.Both male and female Stage 1 of HIV infection
4.Immunosuppression:CD4 Cell Count less than or equal to 400 cells/microlitre
5.Physician consent: participants who are able to perform exercise
6.Who are able to complete 6MWT. 
 
ExclusionCriteria 
Details  1.Critically ill
2.With MSK Conditions(fractures, severe osteoporosis)and Neurological Conditions
3.Who have undergone recent surgeries.
4.Who are psychologically unstable.
5.Severe anaemia
6.Uncontrolled co-morbidities like diabetes,hypertension,heart diseases and chronic lung disease.
7.Recent hospitalization for any major illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.CD4 Cell Count
2.Cardiopulmonary Parameters(BP,RR,SPO2)
3.QOL usinf SF36 Questionnaire 
All outcomes will be assessed at baseline and after 16th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   10/02/2026 
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 initiated after getting clearance from the Institutional Ethical Committee. Participants will be selected based on inclusion and exclusion criteria and informed consent will be taken from the participants and the caretaker. 56 HIV individuals will be considered and they will be randomly allocated by cheat method  into two groups. Group A is experimental group including 28 participants who will receive concurrent exercise training which is a combination of aerobic exercise and resistance training along with 4-square breathing and Group B including 28 participants will receive 4 square breathing with the standard care.
The intervention will be given for 16 weeks. Before starting the pre assessment of participants will be done and post assessment will be done at the end of 16th week.
Group A: Experimental group
The exercise protocol: 
1.Warm Up exercise :– 5-10 mins. (Active mobility exercises, Light jogging and Flexibility movements, Stretching exercises.) 
2. Aerobic Training :- 30mins Type of exercise: 
Static Cycling – 20 mins(40-45% of HRmax), 
Brisk walking – 3 mins, 
Step up and Step down exercises – 3 mins. 
There will be 2 mins break between the exercises. 
Intensity: Low to Moderate.
 Frequency : 3 sessions/week. 
3. Strength training : The participants will have to use therabands of 50% of 1 RM to strengthen the major group of muscles (work load increased by 5% each two weeks).
 The strength training will be carried out for 20- 30 mins with 3 sets ,10 reps for each major group of muscle with rest period of 1-2 mins in between. 
4. Cool Down Exercises:- (5-10 mins) : Stretching and breathing exercises 
5. 4 Square Breathing Exercise:- (4 mins) : 4 square breathing involve four basic steps, each lasting 4 seconds: 
1. Breathing in 
2. Holding the breath
3. Breathing out 
4. Holding the breath
Group B Control group:
4 Square Breathing Exercise:- (4 mins) :
 4 square breathing involve four basic steps, each lasting 4 seconds:
 1. Breathing in 
2. Holding the breath 
3. Breathing out 
4. Holding the breath

Outcome Measures:
• Cardiopulmonary parameters: Respiratory Rate(HR), Blood pressure(BP), oxygen saturation( SpO2)
 • CD4 cell count :- measured pre-intervention & post intervention (via blood test).{Sensitivity=67%, specificity=96%}
• QOL assessed using SF-36 questionnaire(r=0.86)

 
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