| 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
|
|
|
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
|
|
|
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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