Clinical trial NCT06530368: Effect of a Calisthenic Exercises on Premenstrual Symptoms
Official title: Investigation of the Effect of a Calisthenic Home Exercise Program on Premenstrual Symptoms, Pain and Sleep Quality in Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Pain
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of an eight-week calisthenic home exercise program on premenstrual symptoms, pain and sleep quality in young women.

Detailed description: The study was conducted on 30 volunteers who met the inclusion criteria among female students studying at Haliç University Faculty of Health Sciences. The "Premenstrual Syndrome Scale (PMSS)" was used to assess the individuals' premenstrual symptoms; the "Visual Analog Scale (VAS)" was used to assess pain for each of the abdominal, lumbar and general body pain; and the "Pittsburgh Sleep Quality Index (PSQI)" was used to assess sleep quality. Then, the participants were randomly divided into two groups as "Group 1: Control group (n=15)" and "Group 2: - Calisthenic home exercise group (n=15)". Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks. Participants in the second group were informed about calisthenic home exercise programs face to face and were asked to perform these exercises as home exercises for eight weeks. At the end of the treatment process, participants' PMSS, VAS and PSQI scores were re-evaluated.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility criteria: Inclusion Criteria:

* Being a woman between the ages of 18-25
* Studying at Halic University Faculty of Health Sciences
* Voluntarily participating in the study
* Having a normal menstrual cycle
* Not exercising
* Having a score above the mild level on the Premenstrual Syndrome Scale

Exclusion Criteria:

* Having a condition that prevents exercise
* Pregnancy
* Menopause
* Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, myoma/uterine tumor, etc.)

Primary outcomes:
measure: Premenstrual Syndrome Scale (PMSS)
timeFrame: at baseline and at week 8.
measure: Visual Analog Scale (VAS)
timeFrame: at baseline and at week 8.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at baseline and at week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
Study officials:
affiliation: Halic University
name: Duygu Şahin Altaç, PT, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pearce E, Jolly K, Jones LL, Matthewman G, Zanganeh M, Daley A. Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials. BJGP Open. 2020 Aug 25;4(3):bjgpopen20X101032. doi: 10.3399/bjgpopen20X101032. Print 2020 Aug.
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
citation: Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.