Back to resultsEffect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females (PMS)
Primary Purpose
Premenstrual Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medical treatment.
weight reduction
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring "premenstrual syndrome", "diet", "exercise", "obesity"
Eligibility Criteria
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.
Sites / Locations
- Yara Mostafa Soliman
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group (A)
study group (B)
Arm Description
Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
Group B: (Study group): 20 participants 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.
Outcomes
Primary Outcome Measures
Progesterone levels in blood
progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)
body weight
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).
pain level
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
From the patient's perspective this spectrum appears continuous ± their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
Premenstrual syndrome questionnaire (PSQ):
Premenstrual symptoms comprise a wide range of mood, behavioral, and physical symptoms occurring during the luteal phase. The PPSQ, is a patient-reported outcome measurement tool to detect the severity of premenstrual symptoms.
The PMS scales assess ten domains of symptoms: the observer rates the 10 domains by severity with a range of 0 to 4 in eight domains and 0 to 2 in two domains, for a maximum total score of 36.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05707845
Brief Title
Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females
Acronym
PMS
Official Title
Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
"premenstrual syndrome", "diet", "exercise", "obesity"
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group (A)
Arm Type
Placebo Comparator
Arm Description
Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
Arm Title
study group (B)
Arm Type
Experimental
Arm Description
Group B: (Study group): 20 participants
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.
Intervention Type
Drug
Intervention Name(s)
Medical treatment.
Other Intervention Name(s)
NSAID
Intervention Description
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
Intervention Type
Behavioral
Intervention Name(s)
weight reduction
Other Intervention Name(s)
diet program
Intervention Description
weight reduction in the form low caloric diet program for 12 weeks.
Intervention Type
Other
Intervention Name(s)
exercise
Other Intervention Name(s)
aerobic exercise
Intervention Description
aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.
Primary Outcome Measure Information:
Title
Progesterone levels in blood
Description
progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)
Time Frame
12 weeks
Title
body weight
Description
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).
Time Frame
12 weeks
Title
pain level
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
From the patient's perspective this spectrum appears continuous ± their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
Time Frame
12 weeks
Title
Premenstrual syndrome questionnaire (PSQ):
Description
Premenstrual symptoms comprise a wide range of mood, behavioral, and physical symptoms occurring during the luteal phase. The PPSQ, is a patient-reported outcome measurement tool to detect the severity of premenstrual symptoms.
The PMS scales assess ten domains of symptoms: the observer rates the 10 domains by severity with a range of 0 to 4 in eight domains and 0 to 2 in two domains, for a maximum total score of 36.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yara mo soliman, doctoral
Phone
01094909322
Email
yara_soliman93@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
fahiema me okeel, professor
Phone
01013738980
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amal mo youseef, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Yara Mostafa Soliman
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
28650737
Citation
Quintana-Zinn FA, Whitcomb BW, Ronnenberg AG, Bigelow C, Houghton SC, Bertone-Johnson ER. Premenstrual Symptom Patterns and Behavioral Risk Factors in Young Women: A Cross-Sectional Study. J Womens Health (Larchmt). 2017 Oct;26(10):1099-1105. doi: 10.1089/jwh.2016.5921. Epub 2017 Jun 26.
Results Reference
background
PubMed Identifier
31867375
Citation
Vaghela N, Mishra D, Sheth M, Dani VB. To compare the effects of aerobic exercise and yoga on Premenstrual syndrome. J Educ Health Promot. 2019 Oct 24;8:199. doi: 10.4103/jehp.jehp_50_19. eCollection 2019.
Results Reference
background
PubMed Identifier
35871162
Citation
Itriyeva K. The effects of obesity on the menstrual cycle. Curr Probl Pediatr Adolesc Health Care. 2022 Aug;52(8):101241. doi: 10.1016/j.cppeds.2022.101241. Epub 2022 Jul 21.
Results Reference
background
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Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females
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