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CTRI Number  CTRI/2025/04/083931 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of Structured Exercise Program and Jacobson’s Relaxation on Aerobic Capacity, Muscle Strength and Quality of Life in HIV Children. 
Scientific Title of Study   Effectiveness of Structured Exercise Program along with Jacobson’s Relaxation on Fitness Outcomes and Quality of Life in HIV Children: Randomized Control 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 Vishal Anil Lature 
Designation  Masters of Cardiovascular and Respiratory Physiotherapy Student 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India 
Phone  7499057258  
Fax    
Email  vlature92000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishvnath Pawadshetty 
Designation  Professor of Cardiovascular and Respiratory Physiotherapy Student 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India 
Phone  9422710990  
Fax    
Email  physiovish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishvnath Pawadshetty 
Designation  Professor of Cardiovascular and Respiratory Physiotherapy Student 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Department of Cardiovascular and Respiratory Physiotherapy, OPD -F17, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India 
Phone  9422710990  
Fax    
Email  physiovish@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra Institute of Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur 
 
Primary Sponsor  
Name  Maharashtra Institute of Physiotherapy, Latur  
Address  Maharashtra Institute Of Physiotherapy, MIMSR Medical campus, Ambajogai Road, Latur 413531  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Vishal Anil Lature  Maharashtra Institute Of Physiotherapy, Latur  Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17, MIMSR medical campus, Ambajogai Road ,Latur
Latur
MAHARASHTRA 
7499057258

vlature92000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Comittee for Research on Human Subjects   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  Jacobson’s relaxation technique  Jacobson’s relaxation technique - Control Group will be given this technique which is for 20 minutes. 
Intervention  Structured Exercise Program.  The experimental group will be given Aerobic Training and resistance training with Jacobson’s relaxation Intervention – Each session will be of 60-80 mins -3 sessions/week for 8 weeks. (2 months) • Exercise Protocol : 1. Warm-up and stretching exercises – 10 mins. 2. Aerobic Training (Circuit Interval Program): 3. Strength training: 4. Cool Down Exercises – (10 mins) Jacobson’s relaxation technique  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Children diagnosed case of HIV.
2. Both male and female.
3. Children who can complete 6MWT.
4. Physician consent.
5. Stage 1 of HIV infection. (CD4 count) 
 
ExclusionCriteria 
Details  1. Critically ill Children.
2. Children with musculoskeletal and neurological conditions.
3. Children who have undergone recent surgeries.
4. Psychologically unstable Children. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. VO2 max
2. 1 RM strength testing
3. Peds Quality of Life Inventory.
4. Body Mass Index 
1. Baseline
2. 4 weeks
3. 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
6 Minute Walk Test  Participants should be able to complete 6MWT 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/04/2025 
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="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 will be initiated after getting clearance from the Institutional Ethical Committee. • The Participants will be selected based on the inclusion and exclusion criteria and informed consent will be taken from the participants and the caretaker. • 60 HIV children will be considered and they will be randomly allocated into two groups i.e. Experimental group and Control group. The preintervention values will be calculated in the groups using outcome measures. • The physician’s consent will be obtained for the subject’s participation. • Exercise testing will be done three times: at the beginning, at the 4th week and the end of the 8th week. 
• Group A (Experimental group) 
– The experimental group will be given Aerobic Training and resistance training with Jacobson’s relaxation Intervention – Each session will be of 60-80 mins -3 sessions/week for 8 weeks. (2 months) 
 • Exercise Protocol:
1. Warm-up and stretching exercises – 10 mins.  (Active mobility exercises, Stretching exercises.)
2. Aerobic Training (Circuit Interval Program): Type of exercise: - Spot marching 3min - spot jumping – 3 mins - static cycling – 3 mins - Step-up and step-down exercises – 3 mins. There will be a 2-minute (passive interval) break between the exercises. Intensity: Low to Moderate. Frequency: 3 sessions/week. 
3. Strength training: The participants will have to use dumbells, therabands, and weight cuffs of 50% of 1 RM to strengthen the major group of muscles. The strength training will be carried out for 20 minutes, with 10 reps for each major group of muscle, and a rest period of 1-2 minutes in between. 4. Cool Down Exercises – (10 mins) - Active Mobility Exercises. - Upper Body stretch (Shoulder stretch, Tricep stretch) - Lower Body Stretch. 
 Jacobson’s relaxation technique – (20 minutes) Give the following instructions to the Participants. • Gently breathe in, hold, and let go. • Gently pull your toes up towards your knees – just a little – hold briefly – and let go. Recognize the difference. • Press your heels into the floor – hold – and let go. • Pull your knees together – hold briefly – and now let them drift apart a little. Be aware of the new position. • Squeeze your buttocks together – hold – now let go. • Gently pull in your tummy muscles towards your spine – hold briefly – now let go. Feel the difference. • Shoulders – gently pull them up towards your ears, just enough to recognize the tension – hold briefly – now let go. Recognize the new position. • Gently press your elbows and upper arms to the sides of your body – hold for a moment – now let go. • Hands – gently clench – hold – and let go. • Push your head forward slightly, hold briefly, now let your head go back to a balanced position. Feel the difference. • Grit your teeth together – hold briefly – now let your jaw sag slightly. Feel the difference. • Lips – press together – now let go until hardly touching. Purse your lips – now let go and feel the difference. • Press your tongue briefly to the roof of your mouth – hold – and let it drop loosely. Feel the new position. • Eyes – screw them up a little – hold – and let go. • Forehead – frown a little – hold – now let go.  
• Group B (Control group):
 Jacobson’s relaxation technique - 
Only Relaxation Technique will be given to Control Group.
 
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