Clinical trial NCT05834127: Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome
Official title: Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Pain
Keywords: Aerobic exercises
Menstruation
Premenstrual syndrome
Visual analogue scale
Yoga
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 36
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sign and symptoms including mood swings, sensitive breasts, food cravings, exhaustion, irritability, pain and sadness. 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 4 weeks
measure: PMS Scale(premenstrual syndrome scale)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M.phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.