Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome

Pain Clinical Trial

Official title:

Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834127
• Other study ID #: REC/RCR & AHS/23/0508
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Aerobic exercise
Group A will receive aerobic exercise in the form of warm up and cool down (both for 5 min) Treadmill (30 min) based on Target Heart Rate (calculated using Karvina formula at 60%-70% of heart rate reserve). Treatment will be given 3 times a week for 1 month
• Yoga Exercises
Group B will receive yoga movements for 40 min, 3 times a week for 1 month. They will be given yoga movements, including 10 min of Kapalbharti Pranayama which includes automatic inhalation with short and forceful exhalations. 20 min of yoga movements (Cat-cow pose, Child's pose, Plank pose, Cobra pose - each for 5 min). 10 min of meditation/relaxation in Savasana pose

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	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
Primary	PMS Scale(premenstrual syndrome scale)	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