Menstrual CycleNCT06750250
The Effects of Aerobic Exercise During the Different Phases of Menstural Cycle
A study testing Patient education and Aerobics in people with Menstrual Cycle, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- What is being tested?
- Patient education and Aerobics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged 18 - 25 years
- Physical active women
- Weight 40 to 60
- Normal BMI ( 18 to 24)
Who cannot join
- Contraceptive pills
- Perimenupause
- Ammnorehic women
- Pregnant female
- Irregular menstrual cycle
- Non-smokers to minimize confounding cardiovascular effects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sheikh Zayed Hospital,
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: The Effects of Aerobic Exercise on Rate Perceived Exertion, Performance Test Parameters and Behaviour During the Different Phases of Menstural Cycle
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.
- Conditions
- Menstrual Cycle
- Being tested
- Patient education, Aerobics
- Keywords
- aerobic exercise, Physical exertion, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
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
AerobicsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Aerobics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Dec 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750250
- Sponsor's protocol ID
- REC/RCR & AHS/24/0519
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31482137American 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.
PubMed 17079600Magyar 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.
PubMed 571587
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise on Rate Perceived Exertion, Performance Test Parameters and Behaviour During the Different Phases of Menstural Cycle
- ClinicalTrials.gov ID
- NCT06750250
- Acronym / sponsor ID
- REC/RCR & AHS/24/0519
- Conditions
- Menstrual Cycle
- Keywords
- aerobic exercise, Physical exertion, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient education | Active comparator | Other: Patient educationPatient 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 |
| Aerobic exercises | Experimental | Other: AerobicsGroup 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged 18 - 25 years
- Physical active women
- Weight 40 to 60
- Normal BMI ( 18 to 24)
Key exclusion criteria (6 listed)
- Contraceptive pills
- Perimenupause
- Ammnorehic women
- Pregnant female
- Irregular menstrual cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationThe 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 | Other | patient education |
| AerobicsTreadmill: 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 | Other | Aerobic exercises |
Primary outcome
vertical jump test
Time frame: baseline and fourth week
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.
heart rate
Time frame: baseline and fourth week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 31482137Bull 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.
- Background: PubMed 17079600American 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.
- Background: PubMed 571587Magyar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabiya Noor, PHD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education and Aerobics in people with Menstrual Cycle, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical jump test (time frame: baseline and fourth week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750250, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.