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

NCT ID: NCT06317532

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-05-20

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.

Detailed Description

Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women.

Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours.

Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness.

So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lifestyle modification advice

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

Group Type: ACTIVE_COMPARATOR

Lifestyle modification advice

Intervention Type: 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 + Functional exercises

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.

Group Type: EXPERIMENTAL

Lifestyle modification advice

Intervention Type: 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.

Functional exercises

Intervention Type: 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

Interventions

Lifestyle modification advice

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.

Intervention Type: OTHER

Functional exercises

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Their ages will be ranged from 18 to 25 years

2. They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.

3. Their BMI will be ranged from 20 to 25 kg/m2.

4. Having regular menstrual cycles (one every 28-34 days).

5. They will be sedentary virgin females.

6. They are non-smokers.

7. They have not been in any exercise program for three months.

Exclusion Criteria

1. Having secondary dysmenorrhea.

2. Using regular medication or contraceptive pills.

3. Having neuromuscular, metabolic, or cardiac diseases.

4. Having a preexisting condition prevents them from engaging in an exercise program.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Manar Essam Al-Emary

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

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

Role: CONTACT

manaralemary@gmail.com

+20 128 660 0931

Mai Mohamed Ali, PhD

Role: CONTACT

Facility Contacts

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

Role: primary

manaralemary@gmail.com

+20 128 660 0931

Mai Mohamed Ali, PhD

Role: backup

Other Identifiers

P.T.REC/012/004766

Identifier Type: -

Identifier Source: org_study_id