| CTRI Number |
CTRI/2024/11/076141 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective - longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Menstrual Cycle Phases on Psychological Variables Before and After a Constant Fitness Test Plan Among Sub-Elite Athletes with Regular Menstrual Cycle |
|
Scientific Title of Study
|
Impact of Menstrual Cycle Phases on Psychological Measures Pre and Post a Constant Test Plan Among Sub-Elite Eumenorrheic Athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitra M H |
| Designation |
Masters Student |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
2nd Floor, Department of Exercise and Sport Science, MCHP, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9686818488 |
| Fax |
|
| Email |
chaitrahugar64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Tanugatri Majumder |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
2nd Floor, Department of Exercise and Sport Science, MCHP, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
6290891258 |
| Fax |
|
| Email |
tanugatri.majumder@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Tanugatri Majumder |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
2nd Floor, Department of Exercise and Sport Science, MCHP, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
6290891258 |
| Fax |
|
| Email |
tanugatri.majumder@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Exercise and Sports Science, MCHP, Manipal, Karnataka, India PIN 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Exercise and Sports Science MCHP |
| Address |
Department of Exercise and Sports Science, MCHP, Manipal, Karnataka, India. PIN-576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Chaitra M H |
Department of Exercise and Sports Science, MCHP, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Chaitra M H |
Center for Sports Science, Medicine and Research |
Marena Road, Madhav Nagar, Eshwar Nagar, MAHE, Manipal, Karnataka-576104 Udupi
Udupi
KARNATAKA |
9686818488
chaitrahugar64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy menstruating females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Average menstrual cycle length 21 to 35 days (eumenorrheic).
Actively training for their respective sports for at least 6 months or more.
Athlete is training for more than 5 hours per week.
Sub elite athletes (One who train any sport for 5 to 6 hours in a week and one who play district and state level competitions). |
|
| ExclusionCriteria |
| Details |
Uses hormonal contraceptives (currently or within the past 3 months).
Diagnosed with a menstrual disorder.
Diagnosed with an eating disorder.
Currently having musculoskeletal or neurological abnormalities or chronic illness.
Having any injury that interferes with training or could risk participation.
Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psychological fluctuation during the menstrual cycle, assessed using Likert scale questionnaire |
1st day of the menstrual cycle, 5th day of the menstrual cycle, Just before the 1st day of the menstrual cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
12/11/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Primary objective: Impact of menstrual cycle (MC) phases on psychological measures pre and post a constant test plan among sub-elite eumenorrheic athletes.
Justification for study: Fewer research has been conducted to understand the impact of MC phases on psychological measures among sub-elite eumenorrheic athletes. This study will help the coaches and athletes to tailor the training program at par with the MC phases and related symptoms.
The study will be conducted after obtaining permission from the IRC and IEC approval, CTRI registration, and approval will be obtained. Subjects will be enrolled based on inclusion and exclusion criteria. The participants will be volunteering for the study. An informed consent form will be explained, and a signed consent form will be obtained for approval.
On the first visit, demographic, sports-related, health-related, height, and body mass details will be taken. On the same visit, participants are explained about the procedure and familiarized with the protocol.
The time (plus or minus 2 hours of the initial testing session), dietary intake, and nutritional supplements will be standardized or repeated during the testing period, and all will be informed to the participants on the same day.
Before beginning the testing protocol, they will be required to complete the questionnaire (1), which is a pre-test questionnaire. After completing the questionnaire, participants will be asked to perform a series of tests. The tests will include assessments for Flexibility (Sit and Reach test), Muscular Endurance (Push-ups, Partial curl-ups), Anaerobic capacity (Wingate test), Muscle Power (Counter Movement Jump), and Agility (Illinois test). Following the tests, participants will be asked to complete a post-test questionnaire. This process will be repeated on nine separate visits over three months, and participants will be reminded of this protocol before each test.
|