| 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
|
|
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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
|
|
|
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. |
|
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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. |