Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05243927
• Other study ID #: 2022/02/08
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: August 2023

Study information

• Verified date: February 2022
• Source: Ankara Yildirim Beyazit University
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints.

Description:

PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study.

Exclusion Criteria:

Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a history of ischemic heart disease (recently myocardial infarction, angina pectoralis, uncontrolled hypertension, etc.), Having a psychiatric disease, Having a history of malignancy

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Aerobic exercise program
Aerobic exercise will be performed under the supervision of a physiotherapist with a treadmill during 40-60 minutes 3 days a week for 8 weeks
• Spinal stabilization exercise program
Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes 3 days a week for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual pain intensity	Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.	change from baseline at 8 weeks
Secondary	Menstrual symptoms	Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.	change from baseline at 8 weeks
Secondary	Impacts of academic/work performance	Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected".	change from baseline at 8 weeks
Secondary	Impacts of life quality	Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.	change from baseline at 8 weeks
Secondary	Functional and emotional effects	Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale. Options in the 14-item scale are (1) not at all similar to my situation, (2) Not similar to my situation, (3) Both similar and not similar to my situation, (4) considered similar to my situation, (5) very similar to my situation. The total score range is between 14-70. As the scores obtained from the scale increase, the functional and emotional state of being affected by dysmenorrhea also increases.	change from baseline at 8 weeks
Secondary	Sleep quality	Sleep quality will be evaluated with Jenkins Sleep Scale, which consists of 4 items. Each item is rated with a 6-point Likert Scale. The total score ranges from 0 to 20. An average of at least 4 or more is considered a sleep quality disorder.	change from baseline at 8 weeks
Secondary	Trunk muscle endurances	Trunk muscle endurances will be evaluated with McGill's endurance tests. During the tests, individuals will be asked to maintain the determined positions and the elapsed time will be recorded in seconds. The test result is recorded in seconds.	change from baseline at 8 weeks
Secondary	Posture	Posture will be evaluated with PostureScreen Mobile application. PostureScreen Mobile application is an application that evaluates posture anterior-posterior-lateral photographically and provides data by comparing deviations that can be seen in posture according to ideal standing posture.	change from baseline at 8 weeks
Secondary	Pelvic tilt	Pelvic tilt will be evaluated with Palpation Meter (PALM) device. The PALM device is an inclinometer and a palpation meter consisting of two caliper arms, which are used to measure the lumbopelvic position and pelvic tilt.	change from baseline at 8 weeks
Secondary	Functional capacity	Functional capacity will be evaluated with a 2 kilometer walking test. The time taken for walking is calculated by substituting the heart rate, body mass index and age at the end of walking. The result obtained is evaluated according to age and gender, and an appropriateness index is found.	change from baseline at 8 weeks
Secondary	Subjective perception of improvement	Subjective perception of improvement will be evaluated with 4-item Likert-type scale (worse, same, better, improved).	After exercise program (at 8 week)