Menstrual PainNCT05623085
Yoga and Aerobic Exercise Training in Primary Dysmenorrhea
A study testing Aerobic exercise and Yoga exercise in people with Menstrual Pain and Dysmenorrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Pain, Dysmenorrhea
- What is being tested?
- Aerobic exercise and Yoga exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2022to 4 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Yoga and Aerobic Exercise Training in Primary Dysmenorrhea
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.
Read the 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.
- Conditions
- Menstrual Pain, Dysmenorrhea
- Being tested
- Aerobic exercise, Yoga exercise
- Keywords
- Menstrual Pain, Uterine Bleeding, Yoga exercise, Aerobic exercise, Dysmenorrhea
- Medical subject headings
- Dysmenorrhea, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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.
Yoga exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | 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. Receives: Other: Aerobic exercise |
| Yoga Exercise | Active comparator | 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. Receives: Other: Yoga exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary outcomes (17)
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.
Measured: Change in uterine artery blood flow from baseline up to end of 8th week.
Body mass index
Evaluation of body mass index will be done by weighing scale. Results will be presented in kg/m2.
Measured: Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.
body fat percentage
Evaluation of body fat percentage will be done by weighing scale. Results will be presented in %.
Measured: Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.
body fat amount
Evaluation of body fat amount will be done by weighing scale. Results will be presented in kg.
Measured: Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.
lean body weight ratio
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in %.
Measured: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Lean body weight
Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in kg.
Measured: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in cardiovascular fitness from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in muscular static endurance from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in muscular dynamic endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Muscle strength (for lower extremity)
Dominant side knee extension strength for the lower extremity will be measured with the Nicholas Manual Muscle Tester.
Measured: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
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).
Measured: Change in flexibility from baseline up to end of 8th week, 3rd month, and 6th month.
Menstrual stress level
The complaints of individuals in the menstrual, premenstrual and intermenstrual periods will be evaluated in the Menstrual Distress Complaint List.
Measured: Change in menstrual stress level from baseline up to end of 8th week, 3rd month, and 6th month.
Anxiety/depressive symptom level
Anxiety and depressive symptom levels of individuals will be evaluated with the Depression Anxiety Stress Scale.
Measured: Change in anxiety/depressive symptom level from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in quality of life level from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in sleep quality level from baseline up to end of 8th week, 3rd month, and 6th month.
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.
Measured: Change in perception of improvement from baseline up to end of 8th week, 3rd month, and 6th month..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start31 Oct 2022
- Primary completion1 Sep 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Menstrual PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
- Investigators
- Serap Özgül, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623085
- Sponsor's protocol ID
- KA- 21091
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
PubMed 28844356Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
PubMed 12890299Guimaraes AC, Vaz MA, De Campos MI, Marantes R. The contribution of the rectus abdominis and rectus femoris in twelve selected abdominal exercises. An electromyographic study. J Sports Med Phys Fitness. 1991 Jun;31(2):222-30.
PubMed 1836517Bianco A, Lupo C, Alesi M, Spina S, Raccuglia M, Thomas E, Paoli A, Palma A. The sit up test to exhaustion as a test for muscular endurance evaluation. Springerplus. 2015 Jul 2;4:309. doi: 10.1186/s40064-015-1023-6. eCollection 2015.
PubMed 26155448Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8.
PubMed 19661831Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.
PubMed 5749738Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Levine DW, Kripke DF, Kaplan RM, Lewis MA, Naughton MJ, Bowen DJ, Shumaker SA. Reliability and validity of the Women's Health Initiative Insomnia Rating Scale. Psychol Assess. 2003 Jun;15(2):137-48. doi: 10.1037/1040-3590.15.2.137.
PubMed 12847774Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
PubMed 2691207
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Yoga and Aerobic Exercise Training in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05623085
- Acronym / sponsor ID
- KA- 21091
- Conditions
- Menstrual Pain, Dysmenorrhea
- Keywords
- Menstrual Pain, Uterine Bleeding, Yoga exercise, Aerobic exercise, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Aerobic exerciseAerobic 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 | Active comparator | Other: Yoga exerciseYoga 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseIndividuals 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. | Other | Aerobic Exercise |
| Yoga exerciseIndividuals 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. | Other | Yoga Exercise |
Primary outcome
Menstrual pain severity
Time frame: Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.
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.
17 secondary outcomes
Uterine artery blood flow
Time frame: Change in uterine artery blood flow from baseline up to end of 8th week.
Body mass index
Time frame: Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.
body fat percentage
Time frame: Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.
body fat amount
Time frame: Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.
lean body weight ratio
Time frame: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Lean body weight
Time frame: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Cardiovascular fitness
Time frame: Change in cardiovascular fitness from baseline up to end of 8th week, 3rd month, and 6th month.
Muscular static endurance
Time frame: Change in muscular static endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Muscular dynamic endurance
Time frame: Change in muscular dynamic endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Muscle strength (for lower extremity)
Time frame: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Muscle strength (for upper extremity)
Time frame: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Flexibility
Time frame: Change in flexibility from baseline up to end of 8th week, 3rd month, and 6th month.
Menstrual stress level
Time frame: Change in menstrual stress level from baseline up to end of 8th week, 3rd month, and 6th month.
Anxiety/depressive symptom level
Time frame: Change in anxiety/depressive symptom level from baseline up to end of 8th week, 3rd month, and 6th month.
Quality of life level
Time frame: Change in quality of life level from baseline up to end of 8th week, 3rd month, and 6th month.
Sleep quality
Time frame: Change in sleep quality level from baseline up to end of 8th week, 3rd month, and 6th month.
Perception of improvement
Time frame: Change in perception of improvement from baseline up to end of 8th week, 3rd month, and 6th month..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 28844356Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
- Background: PubMed 12890299Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
- Background: PubMed 1836517Guimaraes AC, Vaz MA, De Campos MI, Marantes R. The contribution of the rectus abdominis and rectus femoris in twelve selected abdominal exercises. An electromyographic study. J Sports Med Phys Fitness. 1991 Jun;31(2):222-30.
- Background: PubMed 26155448Bianco A, Lupo C, Alesi M, Spina S, Raccuglia M, Thomas E, Paoli A, Palma A. The sit up test to exhaustion as a test for muscular endurance evaluation. Springerplus. 2015 Jul 2;4:309. doi: 10.1186/s40064-015-1023-6. eCollection 2015.
- Background: PubMed 19661831Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8.
- Background: PubMed 5749738Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 12847774Levine DW, Kripke DF, Kaplan RM, Lewis MA, Naughton MJ, Bowen DJ, Shumaker SA. Reliability and validity of the Women's Health Initiative Insomnia Rating Scale. Psychol Assess. 2003 Jun;15(2):137-48. doi: 10.1037/1040-3590.15.2.137.
- Background: PubMed 2691207Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Özgül, Prof principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Yoga exercise in people with Menstrual Pain and Dysmenorrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 15 Nov 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 Turkey (Türkiye). 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. 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?
Menstrual pain severity (time frame: Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.). 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 NCT05623085, which also lists 9 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 15 Nov 2024.