NCT07037667

Brief Summary

The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is : Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety. Participants will : Do Pilates exercises two times per week for 12 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

June 10, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

PremenstrualAnxietyPilates exercises

Outcome Measures

Primary Outcomes (1)

  • Change in premenstrual anxiety

    State-Trait- Anxiety Inventory for adults (STAI-AD)

    12 weeks following end of treatment

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

This group will do Pilates exercises as single leg lift 10 rep and one leg circle 5 times in each direction for 15 minutes 2 times per week for 12 weeks and receives dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Other: Pilates exercisesOther: Dietary recommendations

Control group

PLACEBO COMPARATOR

This group will receive dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Other: Dietary recommendations

Interventions

Single leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position.

Experimental group

Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants are virgins.
  • All of them suffering from moderate and severe premenstrual anxiety.
  • Their BMI is less than 30 km/m2
  • The regularity of their menstrual cycle is 28-35 days.

You may not qualify if:

  • Smoking.
  • Taking any medications for anxiety.
  • Irregular menstruation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elbeheira governorate

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 25, 2025

Study Start

May 22, 2024

Primary Completion

December 26, 2024

Study Completion

February 4, 2025

Last Updated

June 25, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations