- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669883
Effect of Pilates Exercises Versus Gym Exercises On Primary Dysmenorrhea (dysmenorrhea)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dysmenorrhea is a chronic, recurrent pain that manifests as Menstrual cramps or painful periods. It is the most common Gynecologic problem in women of all ages and races, and one of the Most common causes of pelvic pain . There are two types of dysmenorrhea; primary dysmenorrhea, and Secondary a dysmenorrhea. Primary dysmenorrhea (PD) is defined as Colic pain in the suprapubic region and lower abdomen with Irradiation to the lumbar region and thighs that occurs before or During menstruation in the absence of pelvic diseases. The Manifestation of it usually appears 6 months after menarche. The pain Starts shortly before or at the onset of menses and may last for 3 days ,While, secondary Dysmenorrhea is usually associated with pelvic diseases Inside or outside the uterus that could account for their Symptoms; such as endometriosis, adenomyosis, or uterine Fibroids pharmacological therapies include physiotherapeutic treatments such as the use of heating pads and regular physical exercise, dietary supplements (such as vitamins B, D, and E, or omega-3 fatty acids), acupuncture, yoga, massage, and herbal remedies in the management of PD . The pilates exercises is one of the physiotherapy methods, which improves mental and physical well-being, increases Flexibility, and strengthens muscles through controlled movements done as mat exercises and strengthen the body
. Pilates exercise has a positive effect on health Physical fitness as it increases the muscular Strength, muscular endurance, flexibility, cardiorespiratory endurance and a positive effect on Female sex hormone. Pilates exercise is a good one for the promotion of physical metabolism and Physiological function by positive change of immunoglobulin and sex hormone . The Gym exercises is One of the physiotherapy methods, which is known for strengthening core muscles and being effective in improvement of muscular function of abdominal and low back in addition to range of motion and pain relief. Gym exercises focus on strengthening muscles in the abdominal, leg, arm, and back regions. Additionally, they improve balance, stability, and blood circulation, ultimately contributing to the alleviation of menstrual pain .Intense physical activity is thought to trigger the secretion of beta-endorphins, which function like natural painkillers, thereby alleviating menstrual pain often connected with primary dysmenorrheoea .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nahla ahmed eldersy, central contact person
- Phone Number: 01064605913
- Email: nahla01280731648@gmail.com
Study Contact Backup
- Name: Amir arbi gabr, Professor Study Director
- Phone Number: 01222816912
- Email: dr_amirarabi@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion criteria :
Healthy young virgin females suffering from primary dysmenorrhea diagnosed by the gynecologist.
- Their ages will be ranged from 17-25 years old
- Their body mass index will be ranged from 20-25 kg/ m²
- All females have regular menstruation
Exclusion Criteria:
Females will be excluded from the study if they have;
- Any gynecological problem such as irregular menstrual cycle, secondary dysmenorrhea due to endometriosis, ovarian cyst, uterine fibroid and congenital malformation or pelvic inflammation.
- Cardiovascular diseases
- Respiratory diseases.
- Liver and kidney dysfunctions
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 |
|---|---|
|
Experimental: Pilates Exercises Group
Patients will receive Pilates Exercises 3 sessions per week for 3 months Pilates exercises not only enhanced muscular flexibility but also reduced the pain and other issues occurring in dysmenorrhea.
Additionally, these exercises had a positive impact on the overall quality of life, establishing Pilates as a viable substitute for managing the symptoms of primary dysmenorrhea In accordance with the fundamental principles of Pilates, including centering, precision, concentration, and controlled breathing, this approach has a holistic impact on both physical and psychological well- being.
It has been observed to lead to highly significant alterations in concentration, a reduction in negative emotional effects, and positive behavioral changes One plausible explanation for these effects is the phenomenon of exercise-induced analgesia.
Through Pilates, patients may experience an increase in their pain threshold as a result of adjustments in their endogenous pain control mechanism.
|
patient with primary dysmenorrhea will receive gym Exercises 3 sessions per week for 3 months.
Gym exercises focus on strengthening muscles in the abdominal, leg, arm, and back regions.
Additionally, they improve balance, stability, and blood circulation, ultimately contributing to the alleviation of menstrual pain Intense physical activity is thought to trigger the secretion of beta-endorphins, which function like natural painkillers, thereby alleviating menstrual pain often connected with primary dysmenorrhea .
Gym exercises relieve pain of lower abdomen by control the activation of sympathetic nervous system and positive change of endocrine regulation process through gym exercise, so that pain threshold value was increased due to increase of endorphin .
Gym Exercise is an effective exercise for stabilization of torso.
Because all the body parts are used for the exercise compared to other types of exercises, people can change their posture in various ways correcting their postures
|
|
Experimental: Gym exercises Group
s patient with primary dysmenorrhea will receive gym Exercises 3 sessions per week for 3 months.
Gym exercises focus on strengthening muscles in the abdominal, leg, arm, and back regions.
Additionally, they improve balance, stability, and blood circulation, ultimately contributing to the alleviation of menstrual pain Intense physical activity is thought to trigger the secretion of beta-endorphins, which function like natural painkillers, thereby alleviating menstrual pain often connected with primary dysmenorrhea .
Gym exercises relieve pain of lower abdomen by control the activation of sympathetic nervous system and positive change of endocrine regulation process through gym exercise, so that pain threshold value was increased due to increase of endorphin .
|
Gym Exercises patient with primary dysmenorrhea will receive gym Exercises 3 sessions per week for 3 months.
Gym exercises focus on strengthening muscles in the abdominal, leg, arm, and back regions.
Additionally, they improve balance, stability, and blood circulation, ultimately contributing to the alleviation of menstrual pain Intense physical activity is thought to trigger the secretion of beta-endorphins, which function like natural painkillers, thereby alleviating menstrual pain often connected with primary dysmenorrhea .
Gym exercises relieve pain of lower abdomen by control the activation of sympathetic nervous system and positive change of endocrine regulation process through gym exercise, so that pain threshold value was increased due to increase of endorphin .
Gym Exercise is an effective exercise for stabilization of torso.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of pain intensity
Time Frame: before and after 12 weeks of treatment
|
1. Pain assessment: • Assessment of pain intensity: The Numerical Rating Scale will be use to assess pain intensity for all Participating females in both groups before and after the study program. Each female will be asked to mark a Point on the line between the extreme that is related to her Pain intensity level. |
before and after 12 weeks of treatment
|
|
assessment of primary dysmenorrhea symptoms
Time Frame: before and after 12 weeks of treatment
|
The WALID scale (working, ability Location , Intensity , Days of pain )will be used to determine the severity of primary dysmenorrhea for all participating females in both groups before and after the study program through measuring a Combination of manifestations: subjective (intensity/Wong-Baker, work ability) and objective (days of pain, location) Where (0) without dysmenorrhea, (1-4) mild dysmenorrhea, (5-7) moderate dysmenorrhea, (8-12) sever dysmenorrhea.
|
before and after 12 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of quality of life
Time Frame: before and after 12 of treatment
|
The quality of life enjoyment satisfaction Questionnaire will be used to assess quality of life to all participants in group before and after the treatment and Participants completed the Q-LES-Q-SF questionnaire once during the menstruation phase (when Responses were scored on a five-point scale (from "very poor" to "very good"), where higher scores indicate better enjoyment and satisfaction with life (possible range of raw total score: 14-70).
Scores were added and presented as a percentage of the total maximum possible score.
A percentage of total score of ≥70 represents normal QoL in a community sample.
An additional item (item 16) measured overall life satisfaction and contentment during the past week, on a five-point scale
|
before and after 12 of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Manal ahmed El-shafei, Assisted Professor, Cairo University
- Study Chair: mohamed ahmed Awad, PHD, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- P.T.REC/012/006375
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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