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Premenstrual SyndromePMSNCT05707845

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

A study testing Medical treatment., weight reduction and exercise in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Premenstrual Syndrome
What is being tested?
Medical treatment., weight reduction and exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
1 May 2023to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Yara Mostafa Soliman

    Cairo

Other trials in Egypt

About this study

Official title: Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females

The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.

Read the 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.

Being tested
Medical treatment., weight reduction, exercise
Keywords
"premenstrual syndrome", "diet", "exercise", "obesity"
Medical subject headings
Premenstrual Syndrome, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical treatment.Drug

    Also called NSAID

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

  • weight reductionBehavioural

    Also called diet program

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

  • exerciseOther

    Also called aerobic exercise

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

Study groups in NCT05707845
Study groupRoleWhat they receive
control group (A)Placebo comparatorGroup A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
Receives: Drug: Medical treatment.
study group (B)ExperimentalGroup 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.
Receives: Drug: Medical treatment.; Behavioral: weight reduction; Other: exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progesterone levels in blood

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

    Measured: 12 weeks

  2. 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).

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start1 May 2023
  3. Primary completion1 Aug 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05707845
Sponsor's protocol ID
012/003813
Acronym
PMS
Status last verified
Jun 2024
First submitted
8 Jan 2023
Last updated
11 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28650737

  • 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.

    PubMed 31867375

  • 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.

    PubMed 35871162

Questions about this trial

What is this clinical trial studying?

A study testing Medical treatment., weight reduction and exercise in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progesterone levels in blood (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05707845, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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