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

NCT05707845 | Completed

• 1 other identifier: 012/003813
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

"premenstrual syndrome"; "diet"; "exercise"; "obesity"

Outcome Measures

Primary Outcomes (5)

• Progesterone levels in blood

  progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)

  12 weeks

• 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).

  12 weeks

• cortisol levels in blood

  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.

  12 weeks

• Premenstrual syndrome score

  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.

  12 weeks

• Waist and hip circumference measurements

  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.

  12 weeks

Study Arms (2)

control group (A)

PLACEBO COMPARATOR

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

Drug: Medical treatment.

study group (B)

EXPERIMENTAL

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.

Drug: Medical treatment.; Behavioral: weight reduction; Other: exercise

Interventions

Medical treatment. DRUG

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

Also known as: NSAID

control group (A); study group (B)

weight reduction BEHAVIORAL

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

Also known as: diet program

study group (B)

exercise OTHER

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

Also known as: aerobic exercise

study group (B)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes mellitus.
• Individuals with cardiopulmonary conditions.
• Individuals with any pelvic disease.
• Individuals undergoing radiation therapy or chemotherapy.
• Hepatic or pancreatic diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Yara Mostafa Soliman

Cairo, Egypt

Location

Related Publications (3)

• 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.

  PMID: 28650737 BACKGROUND

• 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.

  PMID: 31867375 BACKGROUND

• 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.

  PMID: 35871162 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Motor Activity; Obesity

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Exercise

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• amal mo youseef, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.SC physical therapy

Model Details: * 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.

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 1, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

EG (1)