- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834127
Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome
Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are many different signs and symptoms of premenstrual syndrome (PMS), including mood swings, sensitive breasts, food cravings, exhaustion, irritability, pain and sadness. Premenstrual syndrome is thought to have affected up to 3 out of every 4 women who are menstruation. A consistent pattern of recurrence exists for symptoms. However, the physical and emotional changes you go through with premenstrual syndrome can range from hardly perceptible to severe. Some people's physical discomfort and emotional stress are so severe that it interferes with their daily life. Regardless of the severity of the symptoms, most women's signs and symptoms go away four days following the start of their menstrual cycle.
Various treatment options are available in the literature to effectively manage these issues through Pharmacotherapies. All these interventions are reported to have beneficial effect for these problems. In this study the effects of aerobic exercises and Yoga on premenstrual syndrome population will be analyzed. This study will be a randomized clinical trial which will incorporate two different interventions. Aerobic exercises and yoga would be administered to the females. 32 patients will randomly divided into two groups. Assessment will be done by using PMS scale and visual analogue scale. The goal of this study to compare the effects of aerobic exercises and yoga on premenstrual syndrome. Subjects meeting the predetermined inclusion criteria will be divided into two groups. 1stgroup will be treated with aerobic exercise. 2nd group will be treated with yoga movements. The pain intensity (Visual Analog Scale) and PMS Scale will be measured before, at the end of 15 days, and after 1 month of treatment program. Recorded values will be analyzed for any change using SPSS25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Jinnah Hospital Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age between 16 and 45 years
- No history of any mental and physical diseases
- No history of joint, motion, muscle, and bone diseases that reduce their abilities of exercise
- Not on any medication and mineral supplements during three menstrual cycles
- Having regular menstrual cycles 24 to 35 days
- No incidents such as relatives' death, marriage, or any medical emergency in the last 3 months
Exclusion Criteria
- Not able to tolerate physical exercise
- Any history of gynecological surgery
- Professional athletes
- Chronic disease: diabetes, hypertension, cardiac disease, infectious disease
- Irregular and infrequent menstrual cycle
- Using intrauterine devices and hormonal therapy
- Pregnant Females
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercises
Group A will receive aerobic exercises.
Treatment will be given 3 times a week for 1 month.
Total number of sessions will be 12
|
Group A will receive aerobic exercise in the form of warm up and cool down (both for 5 min)
|
|
Active Comparator: Yoga exercises
Group B will receive yoga. Treatment will be given for 40 min, 3 times a week for 1 month. Total number of sessions will be 12 |
Group B will receive yoga movements for 40 min, 3 times a week for 1 month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 4 weeks
|
Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, as illustrated.
The patient marks on the line the point that they feel represents their perception of their current state.
The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks
|
4 weeks
|
|
PMS Scale(premenstrual syndrome scale)
Time Frame: 4 weeks
|
Premenstrual Syndrome Scale (PSS) was used based on Diagnostic and Statistical Manual III (DSM-III) and IV (revised)(DSM IV-R) for the evaluation of PMS.
The scale consists of 44 items, 5 of which are Likert type.
The scores range between 44 and 220 and those with a score of 133 and above are considered to have PMS
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.phil, Riphah International University
Publications and helpful links
General Publications
- Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
- A DM, K S, A D, Sattar K. Epidemiology of Premenstrual Syndrome (PMS)-A Systematic Review and Meta-Analysis Study. J Clin Diagn Res. 2014 Feb;8(2):106-9. doi: 10.7860/JCDR/2014/8024.4021. Epub 2014 Feb 3. Erratum In: J Clin Diagn Res. 2015 Jul;9(7):ZZ05.
- Derman O, Kanbur NO, Tokur TE, Kutluk T. Premenstrual syndrome and associated symptoms in adolescent girls. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):201-6. doi: 10.1016/j.ejogrb.2004.04.021.
- Steiner M, Steinberg S, Stewart D, Carter D, Berger C, Reid R, Grover D, Streiner D. Fluoxetine in the treatment of premenstrual dysphoria. Canadian Fluoxetine/Premenstrual Dysphoria Collaborative Study Group. N Engl J Med. 1995 Jun 8;332(23):1529-34. doi: 10.1056/NEJM199506083322301.
- Chen KM, Tseng WS, Ting LF, Huang GF. Development and evaluation of a yoga exercise programme for older adults. J Adv Nurs. 2007 Feb;57(4):432-41. doi: 10.1111/j.1365-2648.2007.04115.x.
- Vaghela N, Mishra D, Sheth M, Dani VB. To compare the effects of aerobic exercise and yoga on Premenstrual syndrome. J Educ Health Promot. 2019 Oct 24;8:199. doi: 10.4103/jehp.jehp_50_19. eCollection 2019.
- Ghaffarilaleh G, Ghaffarilaleh V, Sanamno Z, Kamalifard M, Alibaf L. Effects of Yoga on Quality of Sleep of Women With Premenstrual Syndrome. Altern Ther Health Med. 2019 Sep;25(5):40-47.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on Aerobic exercise
-
Riphah International UniversityCompleted
-
Sultan Abdulhamid Han Training and Research Hospital...RecruitingPhysical InactivityTurkey
-
University of FloridaAmerican Psychological Foundation; Clinical & Translational Science Institute; American Psychological Association (APA)CompletedBrain ConcussionUnited States
-
Radboud University Medical CenterUniversity Hospital, Bonn; University of Dublin, Trinity College; German Sport... and other collaboratorsCompletedMild Cognitive ImpairmentNetherlands, Ireland, Germany
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
National Yang Ming UniversityUnknownKnee OsteoarthritisTaiwan
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanRecruitingCardiology | PsychiatryTaiwan
-
RenJi HospitalRecruitingST-segment Elevation Myocardial Infarction (STEMI)China
-
Federal University of PelotasMinistry of Health, BrazilUnknownHypertension | Cardiovascular Disease | Chronic Kidney Disease | Chronic Renal DiseaseBrazil
-
Acibadem UniversityCompletedMultiple SclerosisTurkey (Türkiye)