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Yoga and Aerobic Exercise Training in Primary Dysmenorrhea

Primary Purpose

Menstrual Pain, Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
Yoga exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Pain focused on measuring Menstrual Pain, Uterine Bleeding, Yoga exercise, Aerobic exercise, Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Individuals who do not have any known disease (systemic, metabolic, etc.), No complaints of acute or chronic pain other than dysmenorrhea, Meeting the primary dysmenorrhea criteria outlined in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe pain felt on the 1st or 2nd day of menstruation), Have a regular menstrual cycle (28± 7 days), The severity of menstrual pain in the last 6 months is ≥ 4 cm according to the Visual Analogue Scale, 18 years and over, Nulligravid (unborn) Volunteer female individuals who gave consent to participate in the study Exclusion Criteria: Individuals undergoing pelvic surgery, Having a history and/or finding of secondary dysmenorrhea, Receiving alternative treatment, Using intrauterine contraceptive device or birth control pill, Individuals with situations where exercise is contraindicated (answering yes to any of the 7 questions on the exercise readiness scale), Not complying with the requirements of the research protocol

Sites / Locations

  • Gamze Nalan ÇinarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exercise

Yoga Exercise

Arm Description

Aerobic exercise group with 8 weeks of individualized exercise according to the Karvonen protocol (heart rate reserve percentage-% HR). Exercise training will be 30 minutes at 50% of HR between weeks 0-2, 45 minutes at 50% of HR between weeks 2-4, 45 minutes at 60% of HR between weeks 4-6 and 6-8 weeks It will be done on the treadmill 3 days a week, for 60 minutes at 60% of HR between weeks. The treadmill speed will be adjusted during exercise to maintain the set target heart rate level.

Yoga exercise group with 8 weeks of individualized exercise program. Exercise training will be done 3 days a week. The duration of the exercise will be adjusted to be the same as the aerobic exercise group.

Outcomes

Primary Outcome Measures

Menstrual pain severity
As primary outcome measures, the highest menstrual pain severity perceived by the participants in their last menstruation and the average of the pain severity in the first 3 days of their menstruation will be evaluated. A 10-cm VAS from zero (no pain at all) to 10 (the worst pain I have ever felt) will be used to determine the severity of menstrual pain. Individuals will be asked to mark the severity of pain they felt in the first 3 days of their last menstruation on 3 separate VAS lines.

Secondary Outcome Measures

Uterine artery blood flow
Determination of uterine artery blood flow changes will be made with Doppler US imaging device. Uterine arterial blood flow will be determined by recording the systole / diastole ratios (S / D), pulsatility indices (PI) and resistance indices (RI) values in the first 3 days of the menstrual cycle of individuals.
Body mass index
Evaluation of body mass index will be done by weighing scale. Results will be presented in kg/m2.
body fat percentage
Evaluation of body fat percentage will be done by weighing scale. Results will be presented in %.
body fat amount
Evaluation of body fat amount will be done by weighing scale. Results will be presented in kg.
lean body weight ratio
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in %.
Lean body weight
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in kg.
Cardiovascular fitness
Cardiovascular fitness will be evaluated with the "6-minute walk test". For this test, which evaluates functional performance; Marking will be made at both starting points of a distance of 30 meters in the corridor. Individuals will be asked to walk for 6 minutes at the highest speed without running, and at the end of 6 minutes, the distance they walked will be recorded in meters. During the exercise test, vital signs such as blood pressure, heart rate, fatigue, shortness of breath, oxygen saturation of all individuals will be recorded before and immediately after the test.
Muscular static endurance
For the abdominal static endurance test, a board will be used to position the patient in 60º flexion. The subjects will be positioned with the trunk at 60°, the hips and knees flexed at 90°, and the hands on the opposite shoulders, leaning against the board. The board will be pulled back 10 cm and the patient will be asked to keep his isometric position as much as possible by contracting his abdominal muscles. As soon as the subject's body touches the board, the test will be terminated and the time to hold the position will be recorded in seconds. The test is continued for a maximum of 120 seconds and after 120 seconds the test will be stopped.
Muscular dynamic endurance
30 seconds sit-up test will be used for dynamic endurance. In the 30-second sit-up test, individuals will be asked to stand up to the level of the lower angle of the scapula and return to the starting position, with the knees flexed at 90 degrees, the hands on the back of the neck and the soles of the feet on the ground, with the command to start in the supine position to evaluate the dynamic endurance of the abdominal muscles. The exact and correct number of starts during 30 seconds will be recorded as the test score.
Muscle strength (for lower extremity)
Dominant side knee extension strength for the lower extremity will be measured with the Nicholas Manual Muscle Tester.
Muscle strength (for upper extremity)
For upper extremity muscle strength, the grip strength of the dominant hand will be measured with a Hand grip dynamometer.
Flexibility
It will be evaluated with the sit-reach test. Individuals will be asked to perform maximum trunk flexion with both hands on top of each other in a long sitting position with legs straight. The distance between the tip of the hand and the board against the soles of the feet will be measured. The distance will be recorded in +/- centimeters (cm).
Menstrual stress level
The complaints of individuals in the menstrual, premenstrual and intermenstrual periods will be evaluated in the Menstrual Distress Complaint List.
Anxiety/depressive symptom level
Anxiety and depressive symptom levels of individuals will be evaluated with the Depression Anxiety Stress Scale.
Quality of life level
The quality of life of individuals will be evaluated with the World Health Organization Quality of Life Scale-Short Form. In the scale consisting of 5 subsections, each section score varies between 4 and 20. Higher scores indicate higher quality of life.
Sleep quality
Sleep quality of individuals will be evaluated with the Women's Health Initiative Insomnia Scale. The higher the score, the higher the degree of insomnia.
Perception of improvement
A 3-point Likert-type scale will be used to evaluate the subjective perception of improvement of individuals. An increase in the score indicates that the perception of improvement increases.

Full Information

First Posted
October 31, 2022
Last Updated
November 11, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05623085
Brief Title
Yoga and Aerobic Exercise Training in Primary Dysmenorrhea
Official Title
Comparison of the Effects of Yoga and Aerobic Exercise Training in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to compare the effects of aerobic exercise and yoga exercises on menstrual pain parameters (pain severity and duration, analgesic usage), uterine artery blood flow, menstrual stress level, physical fitness, anxiety/depressive symptom level, quality of life and sleep quality in individuals with primary dysmenorrhea. This study is a prospective, parallel group, randomized study. Three days a week for eight weeks, the participants in this study will receive individualized yoga and aerobic exercise. In the literature, there are no studies comparing the effectiveness of aerobic exercise and yoga in the management of PD, which is a public health problem that seriously affects women's lives. Especially when aerobic exercise and yoga exercises are considered, there is no study on how much the features such as uterine artery blood flow and physical fitness sub-parameters have changed with these two commonly used exercise types separately in the management of PD.
Detailed Description
The aim of this study is to compare the effects of aerobic exercise and yoga exercises on menstrual pain parameters (pain severity and duration, analgesic usage), uterine artery blood flow, menstrual stress level, physical fitness, anxiety/depressive symptom level, quality of life and sleep quality in individuals with primary dysmenorrhea. This study is a prospective, parallel group, randomized study. It was planned to enroll 44 individuals with Primary Dysmenorrhea in this randomized study. A physical therapist is responsible for all assessments. Participants were included in one of two treatment groups (G1: Aerobic exercise; G2: Yoga exercise). In the literature, there are no studies comparing the effectiveness of aerobic exercise and yoga in the management of PD, which is a public health problem that seriously affects women's lives. Especially when aerobic exercise and yoga exercises are considered, there is no study on how much the features such as uterine artery blood flow and physical fitness sub-parameters have changed with these two commonly used exercise types separately in the management of PD. The results of our study show that norm values can be established by evaluating uterine arterial blood flow and physical fitness, instead of focusing on pharmacological treatment and classical nonpharmacological approaches (warm application, transcutaneous electrical nerve stimulation (TENS), acupuncture, etc.) in individuals with PD. It is aimed to develop new exercise protocols that can be done easily. It is expected that our results, which we will obtain in the light of the original values of our research, will contribute to the literature and guide future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Pain, Dysmenorrhea
Keywords
Menstrual Pain, Uterine Bleeding, Yoga exercise, Aerobic exercise, Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Aerobic exercise group with 8 weeks of individualized exercise according to the Karvonen protocol (heart rate reserve percentage-% HR). Exercise training will be 30 minutes at 50% of HR between weeks 0-2, 45 minutes at 50% of HR between weeks 2-4, 45 minutes at 60% of HR between weeks 4-6 and 6-8 weeks It will be done on the treadmill 3 days a week, for 60 minutes at 60% of HR between weeks. The treadmill speed will be adjusted during exercise to maintain the set target heart rate level.
Arm Title
Yoga Exercise
Arm Type
Active Comparator
Arm Description
Yoga exercise group with 8 weeks of individualized exercise program. Exercise training will be done 3 days a week. The duration of the exercise will be adjusted to be the same as the aerobic exercise group.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Individuals in this group will be given 8-week individualized exercise according to the Karvonen protocol (heart rate reserve percentage-% HR). Exercise training will be 30 minutes at 50% of HR between weeks 0-2, 45 minutes at 50% of HR between weeks 2-4, 45 minutes at 60% of HR between weeks 4-6 and 6-8 weeks It will be done on the treadmill 3 days a week, for 60 minutes at 60% of HR between weeks. The treadmill speed will be adjusted during exercise to maintain the set target heart rate level.
Intervention Type
Other
Intervention Name(s)
Yoga exercise
Intervention Description
Individuals in this group will be given 8-week individualized yoga exercise including stretching, relaxing, strength training. Exercise training will be done 3 days a week. The duration of the exercise will be adjusted to be the same as the aerobic exercise group.
Primary Outcome Measure Information:
Title
Menstrual pain severity
Description
As primary outcome measures, the highest menstrual pain severity perceived by the participants in their last menstruation and the average of the pain severity in the first 3 days of their menstruation will be evaluated. A 10-cm VAS from zero (no pain at all) to 10 (the worst pain I have ever felt) will be used to determine the severity of menstrual pain. Individuals will be asked to mark the severity of pain they felt in the first 3 days of their last menstruation on 3 separate VAS lines.
Time Frame
Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary Outcome Measure Information:
Title
Uterine artery blood flow
Description
Determination of uterine artery blood flow changes will be made with Doppler US imaging device. Uterine arterial blood flow will be determined by recording the systole / diastole ratios (S / D), pulsatility indices (PI) and resistance indices (RI) values in the first 3 days of the menstrual cycle of individuals.
Time Frame
Change in uterine artery blood flow from baseline up to end of 8th week.
Title
Body mass index
Description
Evaluation of body mass index will be done by weighing scale. Results will be presented in kg/m2.
Time Frame
Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.
Title
body fat percentage
Description
Evaluation of body fat percentage will be done by weighing scale. Results will be presented in %.
Time Frame
Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.
Title
body fat amount
Description
Evaluation of body fat amount will be done by weighing scale. Results will be presented in kg.
Time Frame
Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.
Title
lean body weight ratio
Description
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in %.
Time Frame
Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Lean body weight
Description
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in kg.
Time Frame
Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Cardiovascular fitness
Description
Cardiovascular fitness will be evaluated with the "6-minute walk test". For this test, which evaluates functional performance; Marking will be made at both starting points of a distance of 30 meters in the corridor. Individuals will be asked to walk for 6 minutes at the highest speed without running, and at the end of 6 minutes, the distance they walked will be recorded in meters. During the exercise test, vital signs such as blood pressure, heart rate, fatigue, shortness of breath, oxygen saturation of all individuals will be recorded before and immediately after the test.
Time Frame
Change in cardiovascular fitness from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Muscular static endurance
Description
For the abdominal static endurance test, a board will be used to position the patient in 60º flexion. The subjects will be positioned with the trunk at 60°, the hips and knees flexed at 90°, and the hands on the opposite shoulders, leaning against the board. The board will be pulled back 10 cm and the patient will be asked to keep his isometric position as much as possible by contracting his abdominal muscles. As soon as the subject's body touches the board, the test will be terminated and the time to hold the position will be recorded in seconds. The test is continued for a maximum of 120 seconds and after 120 seconds the test will be stopped.
Time Frame
Change in muscular static endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Muscular dynamic endurance
Description
30 seconds sit-up test will be used for dynamic endurance. In the 30-second sit-up test, individuals will be asked to stand up to the level of the lower angle of the scapula and return to the starting position, with the knees flexed at 90 degrees, the hands on the back of the neck and the soles of the feet on the ground, with the command to start in the supine position to evaluate the dynamic endurance of the abdominal muscles. The exact and correct number of starts during 30 seconds will be recorded as the test score.
Time Frame
Change in muscular dynamic endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Muscle strength (for lower extremity)
Description
Dominant side knee extension strength for the lower extremity will be measured with the Nicholas Manual Muscle Tester.
Time Frame
Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Muscle strength (for upper extremity)
Description
For upper extremity muscle strength, the grip strength of the dominant hand will be measured with a Hand grip dynamometer.
Time Frame
Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Flexibility
Description
It will be evaluated with the sit-reach test. Individuals will be asked to perform maximum trunk flexion with both hands on top of each other in a long sitting position with legs straight. The distance between the tip of the hand and the board against the soles of the feet will be measured. The distance will be recorded in +/- centimeters (cm).
Time Frame
Change in flexibility from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Menstrual stress level
Description
The complaints of individuals in the menstrual, premenstrual and intermenstrual periods will be evaluated in the Menstrual Distress Complaint List.
Time Frame
Change in menstrual stress level from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Anxiety/depressive symptom level
Description
Anxiety and depressive symptom levels of individuals will be evaluated with the Depression Anxiety Stress Scale.
Time Frame
Change in anxiety/depressive symptom level from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Quality of life level
Description
The quality of life of individuals will be evaluated with the World Health Organization Quality of Life Scale-Short Form. In the scale consisting of 5 subsections, each section score varies between 4 and 20. Higher scores indicate higher quality of life.
Time Frame
Change in quality of life level from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Sleep quality
Description
Sleep quality of individuals will be evaluated with the Women's Health Initiative Insomnia Scale. The higher the score, the higher the degree of insomnia.
Time Frame
Change in sleep quality level from baseline up to end of 8th week, 3rd month, and 6th month.
Title
Perception of improvement
Description
A 3-point Likert-type scale will be used to evaluate the subjective perception of improvement of individuals. An increase in the score indicates that the perception of improvement increases.
Time Frame
Change in perception of improvement from baseline up to end of 8th week, 3rd month, and 6th month..

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals who do not have any known disease (systemic, metabolic, etc.), No complaints of acute or chronic pain other than dysmenorrhea, Meeting the primary dysmenorrhea criteria outlined in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe pain felt on the 1st or 2nd day of menstruation), Have a regular menstrual cycle (28± 7 days), The severity of menstrual pain in the last 6 months is ≥ 4 cm according to the Visual Analogue Scale, 18 years and over, Nulligravid (unborn) Volunteer female individuals who gave consent to participate in the study Exclusion Criteria: Individuals undergoing pelvic surgery, Having a history and/or finding of secondary dysmenorrhea, Receiving alternative treatment, Using intrauterine contraceptive device or birth control pill, Individuals with situations where exercise is contraindicated (answering yes to any of the 7 questions on the exercise readiness scale), Not complying with the requirements of the research protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serap Özgül, Prof.
Phone
+905339390803
Email
serapky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap Özgül, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gamze Nalan Çinar
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Nalan Çinar, PhD
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak, Prof.
First Name & Middle Initial & Last Name & Degree
Ceren Gürşen, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Sezcan Mümüşoğlu, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Yoga and Aerobic Exercise Training in Primary Dysmenorrhea

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