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NCT Number: NCT06738212

Comparative Effects of Aerobic and Aviva Exercises in Primary Dysmenorrhea

Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. Primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. However, it can affect the quality of life of women and cause inability to carry out daily functioning consequently, absence from school or workplace. Exercise is one of the non-conservative methods to reduce the severity of primary dysmenorrhea. The aim of this study is to compare the effects of aerobic and Aviva exercises on primary dysmenorrhea. This study emphasizes the importance of aerobic exercises and Aviva exercise to reduce the severity of primary Dysmenorrhea. This will help in patients over all recovery and will improve general well-being.

This will be a Randomized clinical trial conducted on 42 participants. The data will be collected from Sharif Medical Complex and Kasrat Gym Lake City by using non-probability convenience sampling technique. Patients with primary dysmenorrhea diagnosed with Walid score questionnaire of age 20-40 will be included. A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises. Participants will be assessed using the Mc Gill pain questionnaire for pain, women health initiative insomnia rating scale will be used for sleep, and brief pain inventory short form for daily functioning and Quality of life enjoyment and satisfaction questionnaire short form for quality of life. Data will be analyzed by using SPSS version 26.0.

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Key information

Conditions

Dysmenorrhea Primary Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sharif Medical Complex & Kasrat gym

Lahore, Punjab Province, 6400, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unmarried females
  • Regular menstrual cycles (every 21-35 days)
  • Moderate to severe menstrual cramp pain

Exclusion criteria

  • Pelvic pathology (endometriosis, chronic pelvic inflammatory disease, adenomyosis)
  • History of pelvic surgery or inflammatory disease
  • Chronic pain or pain disorders (e.g., fibromyalgia)
  • Current use of pain medication or muscle relaxants
  • History of mental health disorders (e.g., depression, anxiety)
  • Inability to understand or complete study assessments
  • Any underlying medical condition that may be contributing to dysmenorrhea (e.g., thyroid disorders, kidney disease)

Treatment and study plan

Group A aerobic exercises

Other

Group A will perform the aerobic exercises (such as bicycling, treadmill and running) Aerobic exercises 15min/session for each exercise, 2 times/week. Frequency: 2 times /week Intensity: Easy to moderate about 60 to 75% of maximum heart rate Type: treadmill, bicycling, running Time: 45min/session

Bicycling:

15

  • Start with gentle, low-intensity cycling and gradually increase as comfort allows - Aim for regular, consistent cycling sessions (e.g., 2-3 times a week,15min/session) - Consider incorporating other exercises, like stretching or yoga, to complement cycling.

Running

To get started with running for dysmenorrhea:

  • Start with short distances and gradually increase as comfort allows
  • Aim for regular, consistent running sessions (e.g., 2-3 times a week,15 minute/session)
  • Consider incorporating other exercises, like stretching or yoga, to complement running.

Group B Aviva exercises

Other

Group B will perform the Aviva exercises in 18 different movements. Aviva exercise intervention method is based on a carefully structured, mild-to-moderate intensity series of 18 movement sequences and aerobic exercises 30min/session, 2 times/week (20)

Aviva Methods of exercises:

These exercises are a carefully structured, intense, and methodical series of movement sequences, including a 5 min warm-up exercise at the beginning and 5 min cooling-down exercises at the end of the session. These exercises are performed in Standing, Sitting, Supine lying, prone lying

Primary outcomes

  1. Mc Gill Pain Questionnaire

    Time frame: 12 weeks

    The Mc Gill pain questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.

    Validity and reliability 0.79 and 0.89.

  2. Women's Health Initiative Insomnia Rating Scale (WHIIRS)

    Time frame: 12 weeks

    A brief five-item scale evaluating insomnia symptoms, the WHIIRS was developed as part of a larger study investigating a range of health issues affecting postmenopausal women. The scale requires individuals to rate the quality of their sleep and the frequency with which they experience certain sleep problems, providing a total score that may be useful for both research and clinical purposes.

  3. Brief Pain Inventory Short Form SF 12

    Time frame: 12 weeks

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is given the bidirectional link between sleep and pain. The range of the scale from 0 to 10.the internal reliability ranging from .95 to .97 for surgical cancer and .82 to .95 ranging for patient with low back pain and arthritis. It is often used as a quality-of-life measure.

  4. Quality of Life Enjoyment and Satisfaction Questionnaire Short Form(Q-LES-Q-SF)

    Time frame: 12 weeks

    Quality of life Enjoyment and Satisfaction Questionnaire Short form evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Aerobic and Aviva Exercises on Pain Quality of Life, Sleep and Daily Functioning in Primary Dysmenorrhea

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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