CTRI Dataset and Description Clinical Trial Registry – India

CTRI Dataset and Description

CTRI Field Description

Public title of study Comparative effect of 8-week High intensity interval training and circuit
training programme on body composition and body image in female students
of university

Scientific title of Comparative effect of 8-week High intensity interval training and circuit
study training programme on body composition and body image in female students
of university
Acronym, if any

Secondary IDs, if any

NA

National Institute of Medical Statistics, New Delhi Page 1 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Principal Investigator’s NAME: Ishika Jain

name and address ADDRESS: (personal? Or official?)
AFFILIATION AND DESIGNATION: BPT student
CONTACT: 8920274070
EMAIL ID: jainjainishika28@gmail.com

Contact person NAME: Dr. Sheetal Kalra

(Scientific Query) ADDRESS: (personal? Or official?)
AFFILIATION AND DESIGNATION: (?)
CONTACT: 9990003410
EMAIL ID: sheetalkalra@dpsru.edu.in

Contact person (Public

Query)

Source/s of monetary or Delhi Pharmaceutical Sciences and Research University

material support

National Institute of Medical Statistics, New Delhi Page 2 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Primary sponsor

National Institute of Medical Statistics, New Delhi Page 3 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Secondary
Sponsor

Countries of India
recruitment

Site/s of study Delhi Pharmaceutical Sciences and Research University

Mehrauli- Badarpur Road, Pushp Vihar Sector 03, New Delhi 110017, India

Name of Ethics
Committee and
approval status

National Institute of Medical Statistics, New Delhi Page 4 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Regulatory clearance
obtained from DCGI

Health Healthy human volunteers

condition/problem
studied

Study type Interventional Trial

National Institute of Medical Statistics, New Delhi Page 5 of 14 1st August 2021
CTRI Dataset and Description
Intervention and
comparator agent
National Institute of Medical Statistics, New Delhi
Clinical Trial Registry – India
Intervention 1: High Intensity Interval Training
Intervention details: Treadmill training on high intensity. It is a 30 min protocol
with 5 mins of warm up followed by 1-2 mins of active phase on high intensity.
This will be followed by the recovery phase. There will be three sets with 3
mins recovery between each set. And lastly 5 mins cool down. The HIIT session
will consist of 30 min protocol, three times a week for 8 weeks.
Intervention 2: Circuit training
Intervention details: training program consist of 10 mins warm up followed by
a circuit of exercises: sit ups, planks, squats, jumping jack, rope jump and
shuttle runs. The participants will perform 25 to 35 secs work on each exercise
with a 20-30 secs recovery. They perform 3 sets with 2-3 mins recovery
between each set. This will be followed by a 10 mins cool-down exercises. The
Circuit training session will consist of 30 min program, three times a week for 8
weeks.
Control : no intervention
Intervention details: No intervention will be provided to this group. It will
be ensured that the subjects do not undergo in any exercise program or
dietary intervention for weight loss.
Page 6 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Inclusion/ Exclusion Inclusion criteria:

1. Age (18-25 yrs.)
criteria
2. Gender: Female
3. BMI: >25 kg/m2
4. Body fat percentage: >28%
5. Female with Body image distortion (BSQ score >80)

Exclusion Criteria:
1. Females who are undergoing any training or diet for weight loss.
2. History of trauma or surgery of rib cage, spine, extremities
3. Patient who refused to give consent
4. Contraindication to perform intensity or circuit training
5. Presence of cardiovascular problem

National Institute of Medical Statistics, New Delhi Page 7 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Method of generating convenience sampling

randomization Subject allocation to either of the experimental groups or control group will be
sequence conducted by a chit method.

Method of allocation
concealment

National Institute of Medical Statistics, New Delhi Page 8 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Blinding/masking

Primary Body composition

outcome/s Body image

National Institute of Medical Statistics, New Delhi Page 9 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Secondary
outcome/s

Target sample size

30

10 in each group.

Phase of trial

National Institute of Medical Statistics, New Delhi Page 10 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

National Institute of Medical Statistics, New Delhi Page 11 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Date of first
enrollment

Estimated duration of 3 months

trial
Recruitment status of
trial

National Institute of Medical Statistics, New Delhi Page 12 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

Brief Summary

Publication

Individual Participant
Data (IPD) Sharing
Statement

National Institute of Medical Statistics, New Delhi Page 13 of 14 1st August 2021
CTRI Dataset and Description Clinical Trial Registry – India

For any clarifications please contact –

Clinical Trials Registry – India National

Institute of Medical Statistics Indian
Council of Medical Research Ansari
Nagar
New Delhi-110029
India
Telephone: 91-11-26588725, 01126588905
Email: ctri@gov.in

National Institute of Medical Statistics, New Delhi Page 14 of 14 1st August 2021