NCT06738212

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

December 12, 2024

Last Update Submit

February 23, 2026

Conditions

Keywords

ExerciseQuality of lifeSleepPain

Outcome Measures

Primary Outcomes (4)

  • Mc Gill Pain Questionnaire

    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.

    12 weeks

  • Women's Health Initiative Insomnia Rating Scale (WHIIRS)

    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.

    12 weeks

  • Brief Pain Inventory Short Form SF 12

    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.

    12 weeks

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

    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).

    12 weeks

Study Arms (2)

Aerobic Exercises

EXPERIMENTAL
Other: Group A aerobic exercises

Aviva Exercises

ACTIVE COMPARATOR
Other: Group B Aviva exercises

Interventions

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

Aviva Exercises

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

Aerobic Exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales suffering from PRIMARY DYSMENORRHEA
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharif Medical Complex & Kasrat gym

Lahore, Punjab Province, 6400, Pakistan

Location

Related Publications (5)

  • Anis T, Hasan S, Lohana N, Salahuddin I, Saeed HJJoXaSU, Natural Sciences Edition. Effects of aerobic program on the severity of dysmenorrhea using WaLIDD score. 2023;19(6):550-4

    BACKGROUND
  • Kovacs Z, Atombosiye E, Hegyi G, Szoke H. The Effect of Aviva Exercise Intervention on Pain Level and Body Awareness in Women with Primary Dysmenorrhea. Medicina (Kaunas). 2024 Jan 20;60(1):184. doi: 10.3390/medicina60010184.

    PMID: 38276063BACKGROUND
  • Elbandrawy AM, Elhakk SM. Comparison between the effects of aerobic and isometric exercises on primary dysmenorrhea. 2021

    BACKGROUND
  • Gohil K, Mehta B. Effect of aerobic exercise on pain and quality of life in women with primary dysmenorrhea. International Journal of Applied Research. 2022;8(6):256-8

    BACKGROUND
  • Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.

    PMID: 29855308BACKGROUND

MeSH Terms

Conditions

Motor ActivityPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hina gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

July 30, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations