EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME

NCT05395169 | Unknown

• 1 other identifier: P.TREC/012/003692
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothesis: There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome. Statement of the problem: Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?

Conditions

Premenstrual Tension

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale (VAS)

  Visual analogue scale (VAS): Degrees of menstrual pain will be assessed using a VAS for all participants in both groups (A\&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"

  assessment will be take 12 weeks

• Menstrual Distress Questionnaire (MDQ)

  Menstrual Distress Questionnaire (MDQ): The subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.

  assessment will be take 12 weeks

Study Arms (2)

medical treatment

EXPERIMENTAL

Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.

Other: dietary supplement ,electronic treadmill ,DASH diet.

the same medication, in addition to DASH diet and aerobic exercise

EXPERIMENTAL

Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.

Other: dietary supplement ,electronic treadmill ,DASH diet.

Interventions

dietary supplement ,electronic treadmill ,DASH diet. OTHER

Control group Will be receive medical treatment for 12 weeks. Study group Will be receive the same medication as in control group in addition to DASH diet and aerobic exercise for 12 weeks.

medical treatment; the same medication, in addition to DASH diet and aerobic exercise

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fifty adolescent females were diagnosed with premenstrual syndrome.
• Their age will be ranged from 15-to 25 years (3 years post-puberty).
• Their body mass index (BMI) will range from 18-25.9 kg/m2.
• All are of regular menstrual cycles.
• All of them suffer from moderate and severe PMS.

You may not qualify if:

• Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
• Having irregular menstruation.
• Any metabolic diseases.
• Any history of gynecological intervention.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Azaa Barmoud, professor

CONTACT

01008410312; drazzakassab@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist physical therapist at Al Delangat Hospital

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF