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Kinesiotaping Versus Pilate Exercises

Primary Purpose

Dysmenorrhea, Exercise

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kinesiotaping application
Pilate exercises program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring kinesiotaping, pilate exercises, primary dysmenorrhea

Eligibility Criteria

14 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Their ages ranged from 14 to 20 years old
  • their body mass index (BMI) would be less than 25 Kg/m2
  • having primary dysmenorrhoea

Exclusion Criteria:

  • skin diseases or cardiac diseases
  • irregular or infrequent menstrual cycles
  • previous abdominal or back operations

Sites / Locations

  • Ghada Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

kinesiotaping

pilate exercises

Arm Description

by kinesiotaping during menstruation for 3 successive menstruation

pilate exercises, 3 sessions per week for 3 months

Outcomes

Primary Outcome Measures

Weight and height scale
Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2

Secondary Outcome Measures

Visual analog scale
For determining pain intensity before and after the treatment course for each girl in both groups (A&B). VAS is a-10 cms line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)

Full Information

First Posted
April 20, 2020
Last Updated
April 21, 2020
Sponsor
Cairo University
Collaborators
Amira Hassan Abdelaziz, Soheir Mahmoud El-Kosery
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1. Study Identification

Unique Protocol Identification Number
NCT04359381
Brief Title
Kinesiotaping Versus Pilate Exercises
Official Title
Kinesiotaping Versus Pilate Exercises on Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 24, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Amira Hassan Abdelaziz, Soheir Mahmoud El-Kosery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.
Detailed Description
Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Exercise
Keywords
kinesiotaping, pilate exercises, primary dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as a randomized controlled trial.
Masking
Investigator
Masking Description
An independent person randomly assigned to all participated subjects to either group (A) (n=30) or group (B) (n=30) by chosen numbers from closed envelopes having numbers that the number generator were chosen randomly.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kinesiotaping
Arm Type
Experimental
Arm Description
by kinesiotaping during menstruation for 3 successive menstruation
Arm Title
pilate exercises
Arm Type
Experimental
Arm Description
pilate exercises, 3 sessions per week for 3 months
Intervention Type
Other
Intervention Name(s)
kinesiotaping application
Intervention Description
kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.
Intervention Type
Other
Intervention Name(s)
Pilate exercises program
Intervention Description
Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .
Primary Outcome Measure Information:
Title
Weight and height scale
Description
Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2
Time Frame
three months
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
For determining pain intensity before and after the treatment course for each girl in both groups (A&B). VAS is a-10 cms line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Their ages ranged from 14 to 20 years old their body mass index (BMI) would be less than 25 Kg/m2 having primary dysmenorrhoea Exclusion Criteria: skin diseases or cardiac diseases irregular or infrequent menstrual cycles previous abdominal or back operations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
Assistant Professor of Physical Therapy for Woman's Health, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghada Elrefaye
City
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

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Kinesiotaping Versus Pilate Exercises

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