- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308119
Comparison Between Pilates Exercises and Aerobic Exercises in Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary dysmenorrhea is a common gynecological condition among young women and is characterized by painful menstrual cramps that may interfere with daily activities and quality of life. Non-pharmacological interventions, particularly therapeutic exercises, have been recommended as safe and effective approaches for managing menstrual pain. Among these interventions, Pilates exercises and aerobic exercises are widely used; however, comparative evidence regarding their relative effectiveness remains limited.
This study is designed as a comparative interventional trial to evaluate and compare the effects of Pilates exercises versus aerobic exercises on pain severity and quality of life in females with primary dysmenorrhea. Eligible participants will be allocated into two intervention groups.
Participants in Group A will undergo a structured Pilates exercise program conducted three sessions per week for eight weeks. Each session will include controlled movements focusing on core stability, flexibility, breathing control, and muscle strengthening, with a total session duration of approximately 30 minutes.
Participants in Group B will receive a supervised aerobic exercise program performed three sessions per week for eight weeks. The aerobic sessions will consist of rhythmic and continuous movements designed to improve cardiovascular endurance, with each session lasting approximately 40 minutes.
Both interventions will be delivered under standardized conditions, and participants will be instructed to maintain their usual daily activities throughout the study period. Assessments will be conducted before the start of the intervention and after completion of the eight-week exercise program to evaluate changes in menstrual pain severity and quality of life.
The findings of this study aim to provide evidence regarding the comparative effectiveness of Pilates and aerobic exercises in the management of primary dysmenorrhea and to support the selection of appropriate exercise-based interventions for improving pain and quality of life in affected women.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Delta university, Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females diagnosed with primary dysmenorrhea
- Age between 18 and 25 years
- Regular menstrual cycle (28-35 days)
- Body mass index (BMI) between 18.5 and 24.9 kg/m²
Exclusion Criteria:
- Presence of any acute or chronic pelvic pathology
- History of regular exercise participation (≥3 days per week, average 30-45 minutes per day)
- Participation in structured physical activities such as swimming, running, or fitness center training
- Inability to perform exercise
- Unwillingness to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates exercises
Patients will receive Pilates exercise, the exercise program was repeated 3 times 8 weeks 30 minute for each leg in session.
Focused on core strengthening, flexibility, and breathing exercises to alleviate menstrual pain."
|
Patients will receive Pilates exercise, the exercise program was repeated 3 times 8 weeks 30 minute for each leg in session.
focuses on core strengthening, flexibility, and breathing techniques designed to reduce menstrual pain and improve overall physical well-being.
|
|
Active Comparator: Aerobic exercises
Patients will receive aerobic exercise, the exercise program was repeated 3 times 8 weeks 40minute for each session.
Including walk-ing and treadmill
|
Patients will receive aerobic exercise, the exercise program was repeated 3 times 8 weeks 40minute for each session.
Including walk-ing and treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
menstrual pain severity
Time Frame: 8 week
|
Pain intensity will be measured using the Visual Analog Scale (VAS) atbaseline and after 8 weeks of Pilates or aerobic exercises.low
score zero pain and high score 10 worst pain imaginable
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change quality of life
Time Frame: 8weeks
|
Short form health survey (SF-12) It was used for assessment of quality of life for aerobic and Pilates before and after treatment. higher scores indicating better health, typically on a 0-100 scale where 50 is the average (standardized). A high score (above 50) means better-than-average health, while a low score (below 50) suggests below-average health. |
8weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Verbal Multidimensional Scoring System (VMSS)
Time Frame: 8weeks
|
Assessment include the need for analgesics, systemic symptoms, and ability to work , typically scoring from 0 (no pain) to 3 (severe pain) |
8weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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