Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females

NCT ID: NCT05707845

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group (A)

Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)

Group Type PLACEBO_COMPARATOR

Medical treatment.

Intervention Type DRUG

Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).

study group (B)

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.

Group Type EXPERIMENTAL

Medical treatment.

Intervention Type DRUG

Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).

weight reduction

Intervention Type BEHAVIORAL

weight reduction in the form low caloric diet program for 12 weeks.

exercise

Intervention Type OTHER

aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.

Interventions

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Medical treatment.

Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).

Intervention Type DRUG

weight reduction

weight reduction in the form low caloric diet program for 12 weeks.

Intervention Type BEHAVIORAL

exercise

aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.

Intervention Type OTHER

Other Intervention Names

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NSAID diet program aerobic exercise

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yara Mostafa Soliman Mahmoud Abdlbary

M.SC physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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amal mo youseef, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

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Yara Mostafa Soliman

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28650737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31867375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35871162 (View on PubMed)

Other Identifiers

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012/003813

Identifier Type: -

Identifier Source: org_study_id

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