| CTRI Number |
CTRI/2020/10/028588 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/04/2021 |
| 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
|
HIIT v/s medium intensity aerobic exercise in children with HIV on ART- RCT |
|
Scientific Title of Study
|
Comparative effect of short-term high intensity interval training versus medium intensity aerobic training on health-related physical fitness and CD4 cells in children with HIV on Anti-Retroviral Therapy- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riddhi Chheda |
| Designation |
PG Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Dr Prabhakar Kores Hospital, JNMC CAMPUS, NEHRU NAGAR, BELGAUM
Belgaum
KARNATAKA
590010
India |
| Phone |
9890259502 |
| Fax |
|
| Email |
riddhichheda01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Metgud |
| Designation |
Head of Department |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Pediatric Department, Dr Prabhakar Kores Hospital, JNMC Campus, Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9890259502 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Riddhi Jitesh Chheda |
| Designation |
PG Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Pediatric Department, Dr Prabhkar Kores Hospital, JNMC Campus, Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9890259502 |
| Fax |
|
| Email |
riddhichheda01@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belgaum, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mahesh J |
Mahesh Foundation |
792, Opp Government Kannada School, Siddheshwar Nagar, Kanbargi, Belgaum,Karnataka
Belgaum
KARNATAKA |
9890259502
support@maheshfoundation.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethical Committee KAHER Institute Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Intensity Interval Training |
Exercises high intensity and with longer intervals,
in present study 30 sec exercises annd interval for 120 sec
|
| Intervention |
Moderate Intensity Aerobic Training |
exercise with moderate intensity and equal rest periods. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with HIV (Asymptomatic) in the age group of 6-18 years.
Receiving HAART for 3 months or more.
Physically active
|
|
| ExclusionCriteria |
| Details |
Physically unfit.
Medically unstable12.
Acute or chronic neurological disturbances.
Chronic cardiopulmonary or metabolic disorders.
•Diagnosed with or had any joint disorder or muscular disorder.
•Severe diarrhoea, incontinence, fever, open skin lesions or bleeding, shortness of breath at rest.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strength
Flexibility
Cardiorespiratory fitness
Body composition
Immunity response CD4 cells
|
At baseline and post 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the effect of short term high intensity interval training versus medium intensity aerobic training on health-related physical fitness and CD4 cells in children with HIV on Anti-retroviral therapy |