- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530368
Effect of a Calisthenic Exercises on Premenstrual Symptoms
July 28, 2024 updated by: Duygu Şahin Altaç, Halic University
Investigation of the Effect of a Calisthenic Home Exercise Program on Premenstrual Symptoms, Pain and Sleep Quality in Young Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Halic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 1: Control group
Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks.
|
|
|
Experimental: Group 2: Calisthenic home exercise group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Premenstrual Syndrome Scale (PMSS)
Time Frame: at baseline and at week 8.
|
The scale, which is widely used in the clinic, has 44 questions that women mark considering "the state of being in the period one week before menstruation".
The lowest score that can be obtained from the scale is 44; the highest score is 220.
In addition, PMS severity classes can be created according to the scores obtained from the scale.
Accordingly, a score of 88 and above from PMSS indicates severe PMS symptoms, and a score below 88 indicates mild PMS symptoms.
Individuals who scored 88 and above from the scale were included in our study.
|
at baseline and at week 8.
|
|
Visual Analog Scale (VAS)
Time Frame: at baseline and at week 8.
|
VAS is a simple, practical, valid, reliable and repeatable measure that evaluates the pain felt by scoring it between 0-10.
Participants were asked to score the pain intensity they felt between 0-10 for each of the abdominal region, lumbar region and general body pain.
|
at baseline and at week 8.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at baseline and at week 8.
|
The PSQI questionnaire used to assess sleep quality includes 18 items for scoring.
A total PSQI score between 0-4 indicates good sleep quality, and a score between 5-21 indicates poor sleep quality.
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at baseline and at week 8.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duygu Şahin Altaç, PT, MSc., Halic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Actual)
April 15, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
July 28, 2024
First Submitted That Met QC Criteria
July 28, 2024
First Posted (Actual)
July 31, 2024
Study Record Updates
Last Update Posted (Actual)
July 31, 2024
Last Update Submitted That Met QC Criteria
July 28, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.07.2024-MÇ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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