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

NCT07891143 | Completed DMC

• 1 other identifier: U/SERC/56(B)-34/2024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (2)

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.

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

Interventions

High Intensity Aerobic Exercise OTHER

intervention intensity is high and consist of structured exercise program

Experimental Group- 55 participants

Eligibility Criteria

• Age: 17 Years - 49 Years
• Gender Eligibility Details: Only Females participated in the study.The unmarried nulliparous female participants from the Universiti Tunku Abdul Rahman between the age 17-49 years were recruited for the study. The females were students from various courses like Physiotherapy, MBBS, Nursing and Traditional Chinese Medicine) as well as the females working in the university as lecturers, admin and support staff. Based on Demographic detail and inclusion criteria of the study the females were shortlisted for the Primary Dysmenorrhea screening to get diagnosed and be eligible to be part of further study. The female participants were recruited using the campus announcements, social media, email notification Interested participants contacted the principal investigator. The participants were given appointments and invited to undergo the next step of eligibility and screening.. The Screening was conducted by a Gynecologist that included history taking and physical examination.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lincoln University College: lead
• Lincoln University College Malaysia: collaborator
• Universiti Tunku Abdul Rahman: collaborator

Study Sites (1)

Physiotherapy department UTAR sungai Long

Cheras, Selangor, 43000, Malaysia

Location

Study Officials

• Nisha Nambiar, PhD

  Lincoln University College

  STUDY DIRECTOR

• Faridah Mohd Said, PhD

  Lincoln University College

  STUDY CHAIR

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: PRINCIPAL INVESTIGATOR
• PI Title: Research Scholar PhD in Health Science

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

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 23, 2026
• Study Start: September 5, 2024
• Primary Completion: September 4, 2025
• Study Completion: March 4, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 5th September 2024- 4th Feb 2026
• Access Criteria: Principal investigator,supervisor, co- supervisor, statistician and if needed publishing study

Locations

MY (1)