NCT06750250

Brief Summary

The menstrual cycle is a term to describe the sequence of events that occur in body as it prepares for the possibility of pregnancy each month. The average length of a menstrual cycle is 28 days. However a cycle can range in length from 21 days to about 35 days and still normal. The menstrual cycle is the time from the first day of your menstrual period until the first day of your next menstrual period. Every person's cycle is slightly different, but the process is the same. Menstruation is the monthly shedding of the lining of the uterus. Menstrual blood which is partly blood and partly tissue from the inside of the uterus flows from the uterus through the cervix and out of the body through vagina. Some people experience symptoms of menstruation and others don't. The intensity of these symptoms can also vary. The most common symptom is cramps. The cramping you feel in your pelvic area is your uterus contracting to release its lining. Menstrual cycle have four phases, menses phase (3 to 7 days of your periods), follicular phase (during the 10 to 14 days), ovulation phase (14 day if cycle is 28 days) and luteal phase (15 to 28 days).These will a Randomized control trial conduct on 42 participants. The data will be collected ffrom ladies gym and muscle work gym by using non-probability convenience sampling technique. The age between 18-25 years participants will perform the aerobic exercises during the different phases of menstrual cycle. A sample will be divided into two groups each group have 21 participants. The Group A control group will Education and Self-Management about health and fitness and perform the walk. Group B intervention group will be given the Aerobic exercise (cycling, treadmill and running). The participants assessed with Borg scale for rate perceived exertion, berg balance questionnaire use for performance test parameters and menstrual stress questionnaire use for behaviour. Data will be analyzed by using SPSS version 26.0.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 20, 2024

Last Update Submit

January 10, 2025

Conditions

Keywords

aerobic exercisePhysical exertionbalance

Outcome Measures

Primary Outcomes (2)

  • vertical jump test

    Have each athlete perform between 3 and 5 single, maximal effort jumps, separated by at least 1 minute. Good vertical jump scores vary depending on the type of jump, i.e. counter movement, squat jump, with arms, without arms etc. The following two sets of normative data are both based on vertical jumps being performed with a counter movement and the use of arms.

    baseline and fourth week

  • heart rate

    The point of 6 correlates to a heart rate of 60 beats per minute in a healthy adult, 7 for 70 beats per minute, and so on. The scoring system measures the extreme ranges of exertion on a scale of 6 to 20.

    baseline and fourth week

Study Arms (2)

patient education

ACTIVE COMPARATOR

Patient Education: Providing information on the benefits of physical activity, proper exercise techniques, and self-care strategies. Self-Management Programs: Empowering women to take an active role in managing their health and fitness. Frequency: 3 session/ month, Intensity: Mild to moderate, Type: Walking, Time: 30 to 45mints /sessions

Other: Patient education

Aerobic exercises

EXPERIMENTAL

Group B will perform the aerobic exercises (such as bicycling, treadmill and running) these exercises. Aerobic exercises performed 30 to 45min/session. Frequency: 3 session /month Intensity: Mild to moderate, Type: treadmill, bicycling, running ,Time: 30 to 45min/month

Other: Aerobics

Interventions

The group A will be Education and Self-Management. Patient Education: Providing information on the benefits of physical activity, proper exercise techniques, and self-care strategies. Self-Management Programs: Empowering women to take an active role in managing their health and fitness. Frequency: 3 session/ month, Intensity: Mild to moderate, Type: Walking Time: 30 to 45mints /sessions

patient education

Treadmill: A manual Treadmill intervention involves moderate-intensity aerobic exercise on a treadmill for 15 minute with the heart rate gradually reaching 75-85% of the maximum. Training frequency was not specified. It significantly reduced menstrual pain intensity 3 session per month. Stationary Bicycling: Start with gentle, low-intensity cycling and gradually increase as comfort allow the duration of exercise 10 mints per month. Running : The running is a low intensity effort of short to moderate duration 10 to 15 mints per mile

Aerobic exercises

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranged 18 - 25 years
  • Physical active women
  • Weight 40 to 60
  • Normal BMI ( 18 to 24)

You may not qualify if:

  • Contraceptive pills
  • Perimenupause
  • Ammnorehic women
  • Pregnant female
  • Irregular menstrual cycle
  • Non-smokers to minimize confounding cardiovascular effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Hospital,

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • Bull JR, Rowland SP, Scherwitzl EB, Scherwitzl R, Danielsson KG, Harper J. Real-world menstrual cycle characteristics of more than 600,000 menstrual cycles. NPJ Digit Med. 2019 Aug 27;2:83. doi: 10.1038/s41746-019-0152-7. eCollection 2019.

    PMID: 31482137BACKGROUND
  • American Academy of Pediatrics Committee on Adolescence; American College of Obstetricians and Gynecologists Committee on Adolescent Health Care; Diaz A, Laufer MR, Breech LL. Menstruation in girls and adolescents: using the menstrual cycle as a vital sign. Pediatrics. 2006 Nov;118(5):2245-50. doi: 10.1542/peds.2006-2481.

    PMID: 17079600BACKGROUND
  • Magyar DM, Boyers SP, Marshall JR, Abraham GE. Regular menstrual cycles and premenstrual molimina as indicators of ovulation. Obstet Gynecol. 1979 Apr;53(4):411-4. No abstract available.

    PMID: 571587BACKGROUND

MeSH Terms

Interventions

Patient Education as TopicExercise

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

December 15, 2024

Primary Completion

April 15, 2025

Study Completion

June 15, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations