Yoga and Aerobic Exercise Training in Primary Dysmenorrhea

NCT05623085 | Completed

• 1 other identifier: KA- 21091
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Pain; Dysmenorrhea

Keywords

Menstrual Pain; Uterine Bleeding; Yoga exercise; Aerobic exercise; Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Change in uterine artery blood flow from baseline up to end of 8th week.

• Body mass index

  Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.

• body fat percentage

  Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.

• body fat amount

  Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.

• lean body weight ratio

  Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.

Study Arms (2)

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.

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.

Other: Yoga exercise

Interventions

Aerobic exercise OTHER

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.

Aerobic Exercise

Yoga exercise OTHER

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.

Yoga Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• years and over,
• Nulligravid (unborn)
• Volunteer female individuals who gave consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Gamze Nalan Çinar

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (9)

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  PMID: 1836517 BACKGROUND

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  PMID: 19661831 BACKGROUND

• 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.

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• 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.

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  PMID: 2691207 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Uterine Hemorrhage

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serap Özgül, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 21, 2022
• Study Start: October 31, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 4, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)