CTRI

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CTRI Number

CTRI/2023/09/057806 [Registered on: 18/09/2023] Trial Registered Prospectively

Last Modified On:

18/09/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Aerobic Exercise]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of Aerobic Exercise on Pain during Menstruation & their Quality of Life

Scientific Title of Study

A Study to identify the prevalence of dysmenorrhea and its impact on quality of life and the effectiveness of an aerobic exercise package on primary dysmenorrhea among collegiate female students of Surat

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Kinjal Subhashchandra Mistri
Designation	PhD Scholar
Affiliation	P P Savani School of Nursing, P P Savani University
Address	HOD cabin, Ground Floor, D009c NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat P P Savani University NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat Surat GUJARAT 394125 India Surat GUJARAT 394125 India
Phone	8758387580
Fax	-
Email	ksmad.26@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sateesh Biradar
Designation	Principal
Affiliation	P P Savani School of Nursing, P P Savani University
Address	Principal Cabin, Ground Floor, D001, NH 8, GETCO, Near Biltech Company, Kosamba Dhamdod, Surat, Gujarat Surat GUJARAT 394125 India
Phone	9512035618
Fax	-
Email	sateesh.biradar@ppsu.ac.in

Details of Contact Person
Public Query

Name	Kinjal Subhashchandra Mistri
Designation	PhD Scholar
Affiliation	P P Savani School of Nursing, P P Savani University
Address	HOD cabin, Ground Floor, D009c, NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat P P Savani University NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat Surat GUJARAT 394125 India Surat GUJARAT 394125 India
Phone	8758387580
Fax	-
Email	ksmad.26@gmail.com

Source of Monetary or Material Support

Adarsh Kelvani Mandal Sanchalit Science and Commerce College, Kosamba, Surat

School of Liberal Arts and Management Studies,P P savani University, Dhamdod, Kosamba,Surat

Shree N F Shah Commerce College, Bhartiya Vidhya Mandal, Kamrej, Surat

Primary Sponsor

Name	P P Savani University
Address	P P Savani University NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat P P Savani University NH 8 GETCO Near Biltech Company Kosamba Dhamdod Gujarat Surat GUJARAT 394125 India
Type of Sponsor	Other [State Private University]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Gomati Tailor	Adarsh Kelvani Mandal Sanchalit Science and Commerce College, Surat	Commerce Department, Room No. 301, Ground Floor, At. Tarsadi, Po. Kosamba Ta. Mangrol, Surat, Gujarat - 394120 Surat GUJARAT	9624424898 - akmkosamba@gmail.com
Dr Ankit Shah	Liberal Arts and Management Studies	Building A, Ground Floor, Room No:A006, NH 8, GETCO, Near Biltech, Village: Dhamdod, Kosamba, Dist.: Surat - 394125. Surat GUJARAT	9974001675 - ankit.shah@ppsu.ac.in
Dr Ashok V Chaudhari	Shree N F Shah Commerce College	Multipurpose Hall, First Floor, Room No:7, Shree Bhartiya Vidhya Mandal, Kamrej Char Rasta, Surat, Gujarat 394185 Surat GUJARAT	9925021293 - avc011292@gmail.com

Details of Ethics Committee

No of Ethics Committees= 3
Name of Committee	Approval Status
PPSU Ethical Review Committee	Approved
PPSU Ethical Review Committee	Approved
PPSU Ethical Review Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N944\|\|Primary dysmenorrhea,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Aerobic Exercise	Aerobic exercise session of 30 minutes with 10 minutes warm up session will be performed by participant for 8 weeks, 3 days in a week. Active exercise of arm, legs, trunk and cross toe touch exercise should be performed by participant during this 30mins session.
Comparator Agent	No Intervention for control group	Usual routine care is taken by female students with primary dysmenorrhea.

Inclusion Criteria

Age From	17.00 Year(s)
Age To	22.00 Year(s)
Gender	Female
Details	1.The students whose age between 17-22 years. 2.The students who have regular menstrual cycle of 28-32 days.

ExclusionCriteria

Details

1. The students who are on treatment related to reproductive disorders.
2. The students who have any known case of pelvic pathology.
3. The students who have chronic disease conditions and are not able to take part in physical activity or sports.
4. The students who are doing regular exercising and athletes.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Visual Pain Analogue scale & QOL Rating Scale	Baseline Measurement & End of 8th Week

Secondary Outcome

Outcome	TimePoints
Menstrual characteristics	Baseline Measurement & End of 8th Week

Target Sample Size

Total Sample Size="128"
Sample Size from India="128"
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

Phase 3

Date of First Enrollment (India)

01/10/2023

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="2"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not applicable

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Dysmenorrhea, a common problem in women of reproductive age, is a very serious problem that can often directly affect the quality of life. Exercise is commonly cited as a probable remedy for menstrual symptoms with limited research available. The aim of this study was to observe the effect of aerobic exercises on Primary dysmenorrhea and quality of life. The study will be conducted in two phases. The cross-sectional phase-1 with 384 random samplings will followed by randomized clinical trial with primary dysmenorrhea cases identified during phase one included in phase-2. The participants are allocated to experimental and control groups during phase-2 through computer-generated randomization. An aerobic exercise session of 30 minutes with a 10-minute warm-up session will be performed by the participant for 8 weeks, 3 days a week. Active exercise of the arm, legs, trunk, and cross-toe touch exercise should be performed by the participant during this 30mins session. At the end of 4 and 8 weeks, the effect will analyze statistically.