Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea

NCT06317532 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004766
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Functional Exercises; Pain; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale (VAS)

  It will be used to measure pain intensity for each female in both groups (A\&B) before and after the end of treatment. The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable. " Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optional tool for describing pain intensity.

  8 weeks

• The Menstrual Distress Questionnaire

  It will be used to evaluate menstruation symptoms and distress for each female in both groups (A\&B) before and after the end of treatment. It consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5-point rating scale from 0-4. Each item has five options, i.e., No, mild, moderate, severe, and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven subscales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, and arousal control). The overall score was interpreted as follows: \<50 - mild, 50 to 70 - moderate, and \>70 severe.

  8 weeks

Secondary Outcomes (2)

• Quality of life enjoyment and satisfaction questionnaire

  8 weeks

• Pressure pain threshold assessment

  8 weeks

Study Arms (2)

Lifestyle modification advice

ACTIVE COMPARATOR

It will include 29 females suffering from primary dysmenorrhea. They will be asked to follow lifestyle modification advice during the program duration.

Other: Lifestyle modification advice

Lifestyle modification advice + Functional exercises

EXPERIMENTAL

It will include 29 females suffering from primary dysmenorrhea. They will be given the same lifestyle modification advice as group A, in addition to performing a combination of various functional exercises (including two stretching exercises, one yoga position, two core-strengthening exercises, two pelvic area exercises, and Kegel exercises), for 45 minutes per session, three times /week for eight weeks.

Other: Lifestyle modification advice; Other: Functional exercises

Interventions

Lifestyle modification advice OTHER

All female participants in groups A and B will be provided with lifestyle modification advice, including recommendations such as reducing caffeine intake, limiting salt consumption, decreasing animal fat consumption, quitting smoking, practicing relaxation techniques, applying heat when needed, considering the use of herbal agents, avoiding cold drinks and foods, and opting for loose, cotton clothing.

Lifestyle modification advice; Lifestyle modification advice + Functional exercises

Functional exercises OTHER

Each female in group (B) will perform the exercise program three times a week for eight weeks at the University Women's Health Unit Exercise protocols mainly consist of relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga, and Pilates

Lifestyle modification advice + Functional exercises

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Their ages will be ranged from 18 to 25 years
• They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.
• Their BMI will be ranged from 20 to 25 kg/m2.
• Having regular menstrual cycles (one every 28-34 days).
• They will be sedentary virgin females.
• They are non-smokers.
• They have not been in any exercise program for three months.

You may not qualify if:

• Having secondary dysmenorrhea.
• Using regular medication or contraceptive pills.
• Having neuromuscular, metabolic, or cardiac diseases.
• Having a preexisting condition prevents them from engaging in an exercise program.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Manar E. Al-Emary, M.Sc. Stud

CONTACT

+20 128 660 0931; manaralemary@gmail.com

Mai Mohamed Ali, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 20, 2024
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

EG (1)