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

NCT05243927 | Unknown

• 1 other identifier: 2022/02/08
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Menstrual symptoms

  change from baseline at 8 weeks

• Impacts of academic/work performance

  change from baseline at 8 weeks

• Impacts of life quality

  change from baseline at 8 weeks

• Functional and emotional effects

  change from baseline at 8 weeks

• Sleep quality

  change from baseline at 8 weeks

Study Arms (2)

Aerobic exercise group

EXPERIMENTAL

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

Stabilization exercise group

ACTIVE COMPARATOR

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

Interventions

Aerobic exercise program OTHER

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

Aerobic exercise group

Spinal stabilization exercise program OTHER

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

Stabilization exercise group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Primary dysmenorrhea is a gynecological problem that can be seen in most women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Officials

• Seyda Toprak Celenay

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000; sydtoprak@hotmail.com

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: associate professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 17, 2022

Record last verified: 2022-02