NCT06500520

Brief Summary

This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 27, 2024

Last Update Submit

July 12, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Visual Analog Scale

    Lower abdomen, leg and low back pain were evaluated with the Visual Analog Scale

    At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

  • Menstrual symptoms questionnaire

    menstrual symptoms were evaluated with the Menstrual Symptoms Questionnaire

    At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

  • Pittsburgh Sleep Quality Index

    sleep quality was evaluated with the Pittsburgh Sleep Quality Index

    At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

  • Health-Related Quality of Life Assessment (SF 36 Short Form)

    Quality of life was evaluated with the Health-Related Quality of Life Assessment (SF 36 Short Form)

    At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

  • Functional and Emotional Dysmenorrhea Questionnaire

    functional and emotional status was evaluated with the Functional and Emotional Dysmenorrhea Questionnaire

    At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

Study Arms (3)

Resisted Exercise group

ACTIVE COMPARATOR

Participants underwent resistance training for 8 weeks, focusing on trunk, upper, and lower body segments with 10-12 reps per exercise at 30-65% intensity. Sessions lasted 50-60 minutes, 3 times weekly

Other: Resisted Exercise group

Stretching Exercise group

ACTIVE COMPARATOR

The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period.

Other: Stretching Exercise group

control group

NO INTERVENTION

No treatment was applied to the control group; they were allowed to use painkillers and continued their normal daily lives.

Interventions

The resisted exercise training program targeted trunk, upper, and lower body segments with 10-12 repetitions at 30-65% intensity, lasting 50-60 minutes per session, 3 times weekly for 8 weeks. Participants determined their maximal repetition through trial training. Maximal power was assessed using concentric 1-maximal repetition (MT). Following a 2-3 minute rest and a 5-minute warm-up (walking), participants performed the 1-MT test to establish their heaviest lift with the correct technique, adjusting resistance levels accordingly. The circuit-style training spanned 9 stations with 2-3 sets per station, each circuit lasting 2-3 minutes with 90-second rests between sets. A 5-minute warm-up and cool-down (walking) preceded and followed each session. Exercises included bilateral elbow flexion, chest press, bilateral shoulder abduction, bilateral knee extension, back extension, sit-ups, knee flexion, hip abduction, and hip adduction.

Resisted Exercise group

The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. They were asked to do exercises such as trunk flexion, pelvic elevation, squatting, trunk lateral flexion, lumbar extensor stretching, lower abdominal stretching, hip adduct stretching, piriformis stretching, and trunk flexor stretching (cobra pose). The holding time was 5 seconds, the rest time was 1 second, and the exercises were applied in 10 repetitions.

Stretching Exercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a score of 60 points or above on the menstrual symptoms scale
  • Having a regular menstrual cycle (24-35 days)
  • Not doing any exercise regularly
  • Being between the ages of 18 and 25
  • Nulliparity
  • Being cooperative and oriented
  • Volunteering to participate in the study

You may not qualify if:

  • Having a medical history of chronic disease (cardiopulmonary, neurological, thyroid gland diseases)
  • Having a history of regular exercise
  • Engaging in regular sexual activity
  • Having undergone gynecological surgical procedures
  • Using hormonal contraceptive drugs or intrauterine devices
  • Using a drug that causes dysmenorrhea
  • Pelvic pathology, pelvic inflammatory diseases, endometriosis, etc. Having a disease that causes secondary dysmenorrhea
  • Using antidepressant medication
  • Having acute musculoskeletal system problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (4)

  • Moradpour, R., "Resistance training improves primary dysmenorrhea symptoms in young girls: A randomized controlled trial", Journal of Physical Activity and Hormones, 3(3): 35-48 (2019).

    BACKGROUND
  • Brown J, Brown S. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD004142. doi: 10.1002/14651858.CD004142.pub2.

    PMID: 20166071BACKGROUND
  • Carroquino-Garcia P, Jimenez-Rejano JJ, Medrano-Sanchez E, de la Casa-Almeida M, Diaz-Mohedo E, Suarez-Serrano C. Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1371-1380. doi: 10.1093/ptj/pzz101.

    PMID: 31665789BACKGROUND
  • Motahari-Tabari N, Shirvani MA, Alipour A. Comparison of the Effect of Stretching Exercises and Mefenamic Acid on the Reduction of Pain and Menstruation Characteristics in Primary Dysmenorrhea: A Randomized Clinical Trial. Oman Med J. 2017 Jan;32(1):47-53. doi: 10.5001/omj.2017.09.

    PMID: 28042403BACKGROUND

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
Director

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 15, 2024

Study Start

December 1, 2023

Primary Completion

February 10, 2024

Study Completion

February 10, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations