Clinical trial NCT05623085: 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
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Pain
Dysmenorrhea
Keywords: Menstrual Pain
Uterine Bleeding
Yoga exercise
Aerobic exercise
Dysmenorrhea
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Menstrual pain severity
timeFrame: Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary outcomes:
measure: Uterine artery blood flow
timeFrame: Change in uterine artery blood flow from baseline up to end of 8th week.
measure: Body mass index
timeFrame: Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.
measure: body fat percentage
timeFrame: Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.
measure: body fat amount
timeFrame: Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.
measure: lean body weight ratio
timeFrame: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Lean body weight
timeFrame: Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Cardiovascular fitness
timeFrame: Change in cardiovascular fitness from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Muscular static endurance
timeFrame: Change in muscular static endurance from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Muscular dynamic endurance
timeFrame: Change in muscular dynamic endurance from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Muscle strength (for lower extremity)
timeFrame: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Muscle strength (for upper extremity)
timeFrame: Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Flexibility
timeFrame: Change in flexibility from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Menstrual stress level
timeFrame: Change in menstrual stress level from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Anxiety/depressive symptom level
timeFrame: Change in anxiety/depressive symptom level from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Quality of life level
timeFrame: Change in quality of life level from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Sleep quality
timeFrame: Change in sleep quality level from baseline up to end of 8th week, 3rd month, and 6th month.
measure: Perception of improvement
timeFrame: Change in perception of improvement from baseline up to end of 8th week, 3rd month, and 6th month..
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gamze Nalan Çinar
Study officials:
affiliation: Hacettepe University
name: Serap Özgül, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
citation: Guimaraes 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.
citation: Bianco 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.
citation: Arnold 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.
citation: Moos 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.
citation: Lovibond 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.
citation: Levine 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.
citation: Jaeschke 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.