Premenstrual Syndrome
Conditions
Keywords
premenstrual syndrome, diet, exercise, obesity
Brief summary
The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.
Detailed description
both groups (A&B) will take their medical treatment in the form of (NSAIDs) and the study group B will under go a siet plan which will fits the participants. Diet plan extends for 12 weeks in the form of caloric restriction program and each woman in group B will perform aerobic exercise program, in the form of treadmill 3 times/week for 8 weeks for 12 weeks. Each session will take about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill by low speed as in warming up.
Interventions
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
BEHAVIORALweight reduction
weight reduction in the form low caloric diet program for 12 weeks.
OTHERexercise
aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
* Two groups pre-test post-test design. * In this study the patients will be randomly assigned into two equal groups (20 patients for each group). (a) Group A: (control group): * Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs). (b) Group B: (Study group): * Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs). * Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Age will range between 20- 30 years old. * only females will participate in the study. * All patients who will be enrolled to the study will have their informed consent.
Exclusion criteria
* Diabetes mellitus. * Individuals with cardiopulmonary conditions. * Individuals with any pelvic disease. * Individuals undergoing radiation therapy or chemotherapy. * Hepatic or pancreatic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progesterone levels in blood | 12 weeks | progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle) |
| body weight | 12 weeks | Weight and height measurement will be measured while the woman is wearing a thin layer of clothes to calculate the BMI according to the following equation for both groups (A&B): BMI = weight/height2 (kg/m2). |
| cortisol levels in blood | 12 weeks | All women in both groups (A&B) will be evaluated before and after the treatment (12 weeks) to show serum cortisol level. A blood sample was taken from each female in both groups (A & B) before and after the treatment to measure the serum cortisol levels, which could reflect anxiety and pain intensity with decreased cortisol levels indicating decreased pain intensity. The cortisol level was assessed 5 days before the first day of the menstrual cycle preceding the treatment program and 5 days before the first day of the menstrual cycle at the end of treatment program,Blood sample of about 5 cm was drawn from the anticubital vein from all participants by disposable sterile syringe by vein puncture to determine plasma cortisol level. All blood samples were taken at 8-9 am and the norm cortisol level at 9 A.M ranges from 4.3-22.4 ug/dl. |
| Premenstrual syndrome score | 12 weeks | The premenstrual syndrome scale comprised 40 questions with three sub-scales (Physiological, Psychological and Behavioural symptoms). This 5-point Likert- type scale consisting of 40 items. The measurements on the scale are set according to the following scoring system: the response Never was scored as 1, rarely as 2, sometimes as 3, very often as 4 and always as 5 points, the total score obtained from the sub-scales established the PMSS total score. The scale's lowest score is 40 and highest score is 200. If the scale's total score reached 80 points or above, this indicates the occurrence of PMS. Increases in the scores indicate an increase in PMS severity. |
| Waist and hip circumference measurements | 12 weeks | Waist circumference was measured at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration; hip circumference was measured at the maximum circumference at the level of femoral trochanter. Then, waist/hip ratio was calculated by dividing waist circumference on hip circumference. All measurements were taken for all patients in both groups (A&B), while the patient was in the standing position, before starting and after the end of the treatment course. |
Countries
Egypt
Outcome results
None listed