- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06129708
Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females
Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was significantly more frequent in students from rural residence (Shaimaa et al., 2018).
There is only one previous study investigate effect of aquatic exercise on primary dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of aerobic ex , however non of the previous studies compared between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore this study was the first one which aimed to investigate the difference between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy, nonsmoking, virginal girls having moderate to severe primary dysmenorrhea (score on pain rating scale > 3).
- Their ages ranged from 14 to 20 years
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They haven't practice any sports at least one year
Exclusion Criteria:
- Any musculoskeletal disorder.
- Cardio-respiratory disease.
- Diabetes, hypertension, or anemia.
- Adolescent girls who have utilized hormonal treatment in the six months prior to study commencement.
- currently undergoing pharmacological therapy for menstrual pain management
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group (A) Aquatic Exercise Group
They participated in an aqua aerobic exercise program, 3 days per week, for 8 weeks
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The aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and
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Experimental: Group (B) Aerobic Exercise Group
They participated in an aerobic exercise program on a treadmill, 3 days per week, for 8 weeks.
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The exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down.
Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill.
Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0
Borg scale) for 30 minutes.
At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of dysmenorrhea severity
Time Frame: 12 weeks
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It was assessed for each participant in the two groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using WaLIDD scale, which has high sensitivity and high specificity.
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12 weeks
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Measurement of pain intensity
Time Frame: 12 weeks
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It was measured for each participant in both groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using the Arabic version of numeric pain rating scale.
The respondents were required to select a number (0-10 integers) that best reflected the intensity of her pain.
In the numeric pain rating scale, 0 represented no pain, 1-3 indicated mild pain, 4-6 indicated moderate pain, while 7-10 indicated severe pain.
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12 weeks
|
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Assessment of pressure pain threshold (PPT)
Time Frame: 12 weeks
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The PPT was measured for each participant in both groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using a pressure algometry.
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12 weeks
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Assessment of health related quality of life
Time Frame: 12 weeks
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The health related quality of life of all participants in both groups (A & B) was evaluated before and after the end of treatment program, using the Arabic version of EQ-5D-3L questionnaire.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sohier M. Elkosery, Prof., Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
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
- P.T.REC/012/004770
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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