Stretching Exercises on Symptoms of Primary Dysmenorrhea

Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea

The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: supervised stretching exercises; Other: non-supervised active stretching home program

Detailed Description

Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Nnjkjk
    • Riyadh, Nnjkjk, Saudi Arabia, 2136
      • Zizi Mohammed Ibrahim Ali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 23 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• BMI of 20-29.9 kg/m2,
• regular menstrual cycle
• length 28-30 day
• cycle bleed from 3 to 7 days,

Exclusion Criteria:

• contraindication to stretching exercise
• taking any hormonal medications:
• smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: supervised stretching exercises :group A; The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks	Other: supervised stretching exercises; 30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations; Other Names: home program stretching exercises
ACTIVE_COMPARATOR: non-supervised active stretching home program: group B; practiced non-supervised active stretching home program	Other: non-supervised active stretching home program; non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations; Other Names: home program of stretching exercises
NO_INTERVENTION: Standard of care: group c; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)	Change from Baseline at pain intensity 4 weeks after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Multidimensional System(VMS)	Verbal Multidimensional System which is a grading system from zero to three and used to evaluate menstruation characteristics including the working ability, the systemic symptoms and analgesia requirement in order to decrease pain with dysmenorrhea	Change from Baseline amenstruation characteristics 4 weeks after

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2019
• Primary Completion (ACTUAL): January 12, 2020
• Study Completion (ACTUAL): February 12, 2020

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: DPTPNU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No