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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Aerobic exercise program; Other: Spinal stabilization exercise program

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise group; 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.	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
Active Comparator: Stabilization exercise group; Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes, 3 days a week for 8 weeks.	Other: Spinal stabilization exercise program; Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes 3 days a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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)

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 2022/02/08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No