Primary DysmenorrheaNCT07891143
Effect of High Intensity Aerobic Exercise on Pain Threshold and Blood Pressure in Females With Primary Dysmenorrhea
A study testing High Intensity Aerobic Exercise in people with Primary Dysmenorrhea, run by Lincoln University College at 1 site in Malaysia.
Trial summary
Primary dysmenorrhea is common among females of reproductive age and is characterized by painful menstrual cramps without an underlying pelvic disease. This pain can affect daily activities, academic performance, work, and quality of life. Read more about this study
- Who is it for?
- Ages 17 to 49 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- High Intensity Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Sep 2024to 4 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females Age 17-49 years
- History of PD for past 3 months with months (Visual Analogue pain scale more than 5 on day 1 and 2 and consecutive days)
- Unmarried
- Nulliparous
- Normal menstrual cycle - 28-35 days cycle
- Body mass Index Normal to overweight(18.5-25 kg/m2 is normal)
Who cannot join
- Any secondary dysmenorrhea or Gynecologic issue
- Active in sports
- Any Cardiorespiratory or musculoskeletal issue
- History of Hypertension
- Oral contraceptives or Analgesic
- Participants need to undergo Primary Dysmenorrhea Screening conducted by a Gynecologist to get diagnosed with Primary Dysmenorrhea and be further eligible to be a part of the further study.
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- This consist of detailed menstrual history taking and abdominal and pelvis palpation by the Gynecologist doctor.
- A general health check-up was also included to rule out any hypertension issue.
- Some important points were considered as well :
- VAS score: Visual analogue scale VAS score greater than 5 is required on both the first and second days of menstruation
- Medication use: Define the required medication-free period, if any, and whether occasional analgesic use is permitted.
- Participants should not be instructed to discontinue prescribed medication without appropriate clinical guidance.
- Blood pressure safety: Since intervention involves high-intensity aerobic exercise and blood pressure is an outcome, include a suitable pre-exercise screening procedure and safety criteria for elevated blood pressure. Blood pressure was measured in this session as well along with BMI.
- Medication use: Define the required medication-free period, if any, and whether occasional analgesic use is permitted.
- Participants should not be instructed to discontinue prescribed medication without appropriate clinical guidance.
- Active in sports or athletics were not eligible.
- Blood pressure safety: Since intervention involves high-intensity aerobic exercise and blood pressure is an outcome a suitable pre-exercise screening procedure and safety criteria for elevated blood pressure was included.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Physiotherapy department UTAR sungai Long
Cheras, Selangor, 43000
About this study
Primary dysmenorrhea is common among females of reproductive age and is characterized by painful menstrual cramps without an underlying pelvic disease. This pain can affect daily activities, academic performance, work, and quality of life.
This study aims to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea. The study will assess changes in pain threshold and blood pressure following high-intensity aerobic exercise. The findings may help determine whether this type of exercise can improve pain tolerance and influence blood pressure in females experiencing painful menstrual periods.
Participants will perform a high-intensity aerobic exercise program, and their pain threshold level will be assessed by a digital algometer before and after the exercise intervention and the blood pressure changes will also be studied.
Read the detailed description
Primary dysmenorrhea is a common gynecological condition characterized by recurrent, cramping pain in the lower abdomen during menstruation in the absence of identifiable pelvic pathology. It is associated with increased production of prostaglandins, which leads to excessive uterine contractions, reduced uterine blood flow, and menstrual pain. Primary dysmenorrhea may negatively affect daily activities, academic performance, work productivity, sleep, and overall quality of life.
Exercise has been suggested as a non-pharmacological approach for managing menstrual pain. Aerobic exercise may influence pain perception through the activation of endogenous pain-inhibitory mechanisms, including the release of endogenous opioids and other pain-modulating substances. Exercise may also improve cardiovascular function and autonomic regulation, potentially influencing blood pressure. However, the effects of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea require further investigation.
The purpose of this study is to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females diagnosed with primary dysmenorrhea. The study will evaluate changes in pain threshold and blood pressure following a structured high-intensity aerobic exercise intervention. The exercise protocol followed is at 85% of heart rate given three times a week for 25 minutes /session. This is according to the American heart association guideline for high intensity Aerobic Exercises
Eligible participants will be females of reproductive age with a history of primary dysmenorrhea who meet the predefined inclusion and exclusion criteria. Participants will undergo baseline assessment, including demographic and relevant clinical information, pain threshold measurement, and blood pressure measurement using standardized procedures.
The intervention group will participate in a structured high-intensity aerobic exercise programme according to the study protocol. Maximum heart rate is calculated for each participant using the Karvonen's Formula and then maximum heart rate is calculated for each participant accordingly. The participants are advised to wear comfortable clothing and also wear smart watch. The exercise programme will specify the type of aerobic activity, exercise intensity, duration of each session, frequency of sessions, total intervention period, and warm-up and cool-down procedures. Exercise intensity will be monitored using an appropriate method, such as heart-rate monitoring or the rating of perceived exertion. Rate of perceived exertion scale was used to to guage the exercise effect after the session and was recorded. Participants will be supervised or monitored as specified in the protocol to promote adherence and safety. The exercises consist of jumping jacks, step climber, mountain climber, knee hugs, lunges, partial squats and others. This exercises were selected and validated by five experts from the field of physiotherapy and exercise.
Pain threshold will be assessed using a standardized and reproducible measurement method, such as a pressure pain threshold assessment with an appropriate algometer, if applicable to the study protocol. Blood pressure will be measured using a validated blood pressure monitor under standardized resting conditions. Systolic and diastolic blood pressure will be recorded at the specified assessment time points. Baseline and post-intervention measurements will be compared to determine changes associated with the exercise programme.
The primary outcome will be the change in pain threshold from baseline to post-intervention. The secondary outcome will be the change in systolic and diastolic blood pressure over the same period. Additional outcomes, if included in the study protocol, may include menstrual pain intensity, exercise adherence, and intervention-related adverse events.
The findings of this study may contribute to a better understanding of the effects of high-intensity aerobic exercise on pain sensitivity and cardiovascular responses in females with primary dysmenorrhea. The results may help inform the development of evidence-based exercise recommendations as a potential non-pharmacological approach to managing primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- High Intensity Aerobic Exercise
- Keywords
- Pain Threshold, Primary Dysmennorrhea, Blood Pressure, High Intensity Aerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Aerobic ExerciseOther
intervention intensity is high and consist of structured exercise program
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group- 55 participants | Experimental | High Intensity Aerobic Exercise given at 85 % of heart rate. 3 times/week /25 minute per session with 5 minutes warm up and 5 minutes cool down. Receives: Other: High Intensity Aerobic Exercise |
| Control group-55 participants | No intervention | No treatment given.Participants instructed to carry on with usual lifestyle and do not begin any new exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold
Pain Threshold: Measured using a digital algometer at four muscle sites: trapezius (5 cm from the acromion), biceps (15 cm from the glenoid cavity or 9 cm above the elbow crease), rectus abdominis (4 cm lateral to the umbilicus), and gastrocnemius (midpoint between the popliteal fossa and heel). The 1 cm² probe is pressed vertically at 30 kPa until pain is reported; the device automatically records the threshold in kilograms.
Measured: Pretest (menstrual days 1-4), post-test 1 (week 4), and post-test 2 (week 8), during menstrual days 1-4.
Blood Pressure
It is measured using Omron Digital blood pressure monitor. Both Systolic and Diastolic blood pressure will be measured.
Measured: On Pretest- all days of menses (day1-day4) .For Post test 1 (at end of 4th week) , Post test 2(at end of 8th week) during day1-day 4 of menses. Recorded in the left arm three times and average is noted. Measured for experimental and control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start5 Sep 2024
- Primary completion4 Sep 2025
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- 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
- Model description
- 2 groups- experimental and control. Experimental group gets high intensity aerobic exercise Control group receives no treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln University College
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln University College Malaysia, Universiti Tunku Abdul Rahman
- Responsible party
- Principal investigator, Swapneela Jacob, Lincoln University College
- Investigators
- Nisha Nambiar, PhD, Study director, Lincoln University CollegeFaridah Mohd Said, PhD, Study chair, Lincoln University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891143
- Sponsor's protocol ID
- U/SERC/56(B)-34/2024
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: pain scores, blood pressure levels
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Aerobic Exercise on Pain Threshold and Blood Pressure in Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07891143
- Acronym / sponsor ID
- U/SERC/56(B)-34/2024
- Conditions
- Primary Dysmenorrhea
- Keywords
- Pain Threshold, Primary Dysmennorrhea, Blood Pressure, High Intensity Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Lincoln University CollegeUniversity, hospital or other
- Collaborators
- Lincoln University College Malaysia, Universiti Tunku Abdul Rahman
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 23 Oct 2026 (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.
Primary dysmenorrhea is common among females of reproductive age and is characterized by painful menstrual cramps without an underlying pelvic disease. This pain can affect daily activities, academic performance, work, and quality of life.
This study aims to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea. The study will assess changes in pain threshold and blood pressure following high-intensity aerobic exercise. The findings may help determine whether this type of exercise can improve pain tolerance and influence blood pressure in females experiencing painful menstrual periods.
Participants will perform a high-intensity aerobic exercise program, and their pain threshold level will be assessed by a digital algometer before and after the exercise intervention and the blood pressure changes will also be studied.
Detailed description
Primary dysmenorrhea is a common gynecological condition characterized by recurrent, cramping pain in the lower abdomen during menstruation in the absence of identifiable pelvic pathology. It is associated with increased production of prostaglandins, which leads to excessive uterine contractions, reduced uterine blood flow, and menstrual pain. Primary dysmenorrhea may negatively affect daily activities, academic performance, work productivity, sleep, and overall quality of life.
Exercise has been suggested as a non-pharmacological approach for managing menstrual pain. Aerobic exercise may influence pain perception through the activation of endogenous pain-inhibitory mechanisms, including the release of endogenous opioids and other pain-modulating substances. Exercise may also improve cardiovascular function and autonomic regulation, potentially influencing blood pressure. However, the effects of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea require further investigation.
The purpose of this study is to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females diagnosed with primary dysmenorrhea. The study will evaluate changes in pain threshold and blood pressure following a structured high-intensity aerobic exercise intervention. The exercise protocol followed is at 85% of heart rate given three times a week for 25 minutes /session. This is according to the American heart association guideline for high intensity Aerobic Exercises
Eligible participants will be females of reproductive age with a history of primary dysmenorrhea who meet the predefined inclusion and exclusion criteria. Participants will undergo baseline assessment, including demographic and relevant clinical information, pain threshold measurement, and blood pressure measurement using standardized procedures.
The intervention group will participate in a structured high-intensity aerobic exercise programme according to the study protocol. Maximum heart rate is calculated for each participant using the Karvonen's Formula and then maximum heart rate is calculated for each participant accordingly. The participants are advised to wear comfortable clothing and also wear smart watch. The exercise programme will specify the type of aerobic activity, exercise intensity, duration of each session, frequency of sessions, total intervention period, and warm-up and cool-down procedures. Exercise intensity will be monitored using an appropriate method, such as heart-rate monitoring or the rating of perceived exertion. Rate of perceived exertion scale was used to to guage the exercise effect after the session and was recorded. Participants will be supervised or monitored as specified in the protocol to promote adherence and safety. The exercises consist of jumping jacks, step climber, mountain climber, knee hugs, lunges, partial squats and others. This exercises were selected and validated by five experts from the field of physiotherapy and exercise.
Pain threshold will be assessed using a standardized and reproducible measurement method, such as a pressure pain threshold assessment with an appropriate algometer, if applicable to the study protocol. Blood pressure will be measured using a validated blood pressure monitor under standardized resting conditions. Systolic and diastolic blood pressure will be recorded at the specified assessment time points. Baseline and post-intervention measurements will be compared to determine changes associated with the exercise programme.
The primary outcome will be the change in pain threshold from baseline to post-intervention. The secondary outcome will be the change in systolic and diastolic blood pressure over the same period. Additional outcomes, if included in the study protocol, may include menstrual pain intensity, exercise adherence, and intervention-related adverse events.
The findings of this study may contribute to a better understanding of the effects of high-intensity aerobic exercise on pain sensitivity and cardiovascular responses in females with primary dysmenorrhea. The results may help inform the development of evidence-based exercise recommendations as a potential non-pharmacological approach to managing primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups- experimental and control. Experimental group gets high intensity aerobic exercise Control group receives no treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group- 55 participants | Experimental | Other: High Intensity Aerobic ExerciseHigh Intensity Aerobic Exercise given at 85 % of heart rate. 3 times/week /25 minute per session with 5 minutes warm up and 5 minutes cool down. |
| Control group-55 participants | No intervention | –No treatment given.Participants instructed to carry on with usual lifestyle and do not begin any new exercise program |
Who may qualify
- Ages
- 17 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Females Age 17-49 years
- History of PD for past 3 months with months (Visual Analogue pain scale more than 5 on day 1 and 2 and consecutive days)
- Unmarried
- Nulliparous
- Normal menstrual cycle - 28-35 days cycle
Key exclusion criteria (17 listed)
- Any secondary dysmenorrhea or Gynecologic issue
- Active in sports
- Any Cardiorespiratory or musculoskeletal issue
- History of Hypertension
- Oral contraceptives or Analgesic
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 |
|---|---|---|
| High Intensity Aerobic Exerciseintervention intensity is high and consist of structured exercise program | Other | Experimental Group- 55 participants |
Primary outcome
Pain Threshold
Time frame: Pretest (menstrual days 1-4), post-test 1 (week 4), and post-test 2 (week 8), during menstrual days 1-4.
Pain Threshold: Measured using a digital algometer at four muscle sites: trapezius (5 cm from the acromion), biceps (15 cm from the glenoid cavity or 9 cm above the elbow crease), rectus abdominis (4 cm lateral to the umbilicus), and gastrocnemius (midpoint between the popliteal fossa and heel). The 1 cm² probe is pressed vertically at 30 kPa until pain is reported; the device automatically records the threshold in kilograms.
Blood Pressure
Time frame: On Pretest- all days of menses (day1-day4) .For Post test 1 (at end of 4th week) , Post test 2(at end of 8th week) during day1-day 4 of menses. Recorded in the left arm three times and average is noted. Measured for experimental and control group.
It is measured using Omron Digital blood pressure monitor. Both Systolic and Diastolic blood pressure will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. pain scores, blood pressure levels
Related trials for Primary Dysmenorrhea
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Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
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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. This study is not recruiting at the moment.
Nisha Nambiar, PhD study director
Lincoln University College
Faridah Mohd Said, PhD study chair
Lincoln University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Aerobic Exercise in people with Primary Dysmenorrhea, run by Lincoln University College at 1 site in Malaysia.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 23 Oct 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Threshold (time frame: Pretest (menstrual days 1-4), post-test 1 (week 4), and post-test 2 (week 8), during menstrual days 1-4.). 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?
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 23 Oct 2026.