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Effect of High Intensity Aerobic Exercise on Pain Threshold and Blood Pressure in Females With Primary Dysmenorrhea

Effect of High Intensity Aerobic Exercise on Pain Threshold and Blood Pressure in Females With Primary Dysmenorrhea

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07891143
Enrollment
110
Registered
2026-10-23
Start date
2024-09-05
Completion date
2026-03-04
Last updated
2026-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Keywords

Pain Threshold, Primary Dysmennorrhea, Blood Pressure, High Intensity Aerobic Exercise

Brief 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. 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.

Interventions

intervention intensity is high and consist of structured exercise program

Sponsors

Lincoln University College
Lead SponsorOTHER
Lincoln University College Malaysia
CollaboratorOTHER
Universiti Tunku Abdul Rahman
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

2 groups- experimental and control. Experimental group gets high intensity aerobic exercise Control group receives no treatment

Eligibility

Sex/Gender
FEMALE
Age
17 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain ThresholdPretest (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 PressureOn 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.

Countries

Malaysia

Contacts

STUDY_DIRECTORNisha Nambiar, PhD

Lincoln University College

STUDY_CHAIRFaridah Mohd Said, PhD

Lincoln University College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 24, 2026