NCT06530368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Premenstrual Syndrome Scale (PMSS)

    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)

    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)

    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.

    at baseline and at week 8.

Study Arms (2)

Group 1: Control group

NO INTERVENTION

Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks.

Group 2: Calisthenic home exercise group

EXPERIMENTAL

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.

Other: Calisthenic home exercise programs

Interventions

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.

Group 2: Calisthenic home exercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Duygu Şahin Altaç, PT, MSc.

    Halic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc.

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

February 15, 2024

Primary Completion

April 15, 2024

Study Completion

May 15, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations