Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome

NCT05834127 | Completed

• 1 other identifier: REC/RCR & AHS/23/0508
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome; Pain

Keywords

Aerobic exercises; Menstruation; Premenstrual syndrome; Visual analogue scale; Yoga

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Aerobic exercises

EXPERIMENTAL

Group A will receive aerobic exercises. Treatment will be given 3 times a week for 1 month. Total number of sessions will be 12

Other: Aerobic exercise

Yoga exercises

ACTIVE COMPARATOR

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

Other: Yoga Exercises

Interventions

Aerobic exercise OTHER

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

Aerobic exercises

Yoga Exercises OTHER

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

Yoga exercises

Eligibility Criteria

• Age: 16 Years - 45 Years
• Gender Eligibility Details: Because PMS condition is only present in females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 24701496 BACKGROUND

• 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.

  PMID: 15358465 BACKGROUND

• 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.

  PMID: 7739706 BACKGROUND

• 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.

  PMID: 17291207 BACKGROUND

• 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.

  PMID: 31867375 BACKGROUND

• 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.

  PMID: 2197679 BACKGROUND

• 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.

  PMID: 31221931 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sabiha Arshad, M.phil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: November 20, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)