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

Primary Purpose

Primary Dysmenorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic exercise program
Spinal stabilization exercise program
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Aerobic exercise group

    Stabilization exercise group

    Arm Description

    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 exercises will be performed with a physiotherapist during 40-60 minutes, 3 days a week for 8 weeks.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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".
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Subjective perception of improvement
    Subjective perception of improvement will be evaluated with 4-item Likert-type scale (worse, same, better, improved).

    Full Information

    First Posted
    February 8, 2022
    Last Updated
    February 8, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05243927
    Brief Title
    Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
    Official Title
    Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Dysmenorrhea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobic exercise group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Stabilization exercise group
    Arm Type
    Active Comparator
    Arm Description
    Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes, 3 days a week for 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic exercise program
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Spinal stabilization exercise program
    Intervention Description
    Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes 3 days a week for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Menstrual pain intensity
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Secondary Outcome Measure Information:
    Title
    Menstrual symptoms
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Impacts of academic/work performance
    Description
    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".
    Time Frame
    change from baseline at 8 weeks
    Title
    Impacts of life quality
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Functional and emotional effects
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Sleep quality
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Trunk muscle endurances
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Posture
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Pelvic tilt
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Functional capacity
    Description
    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.
    Time Frame
    change from baseline at 8 weeks
    Title
    Subjective perception of improvement
    Description
    Subjective perception of improvement will be evaluated with 4-item Likert-type scale (worse, same, better, improved).
    Time Frame
    After exercise program (at 8 week)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Primary dysmenorrhea is a gynecological problem that can be seen in most women.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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