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Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic exercise
Yoga Exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Aerobic exercises, Menstruation, Premenstrual syndrome, Visual analogue scale, Yoga

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah Hospital LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercises

Yoga exercises

Arm Description

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 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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
June 6, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05834127
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Pain
Keywords
Aerobic exercises, Menstruation, Premenstrual syndrome, Visual analogue scale, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises
Arm Type
Experimental
Arm Description
Group A will receive aerobic exercises. Treatment will be given 3 times a week for 1 month. Total number of sessions will be 12
Arm Title
Yoga exercises
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Yoga Exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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
Time Frame
4 weeks
Title
PMS Scale(premenstrual syndrome scale)
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Because PMS condition is only present in females
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabiha Arshad, M.phil
Phone
03248495979
Email
s.arshad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.phil
Phone
03248495979
Email
s.arshad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Noor Javaid, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24701496
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. Erratum In: J Clin Diagn Res. 2015 Jul;9(7):ZZ05.
Results Reference
background
PubMed Identifier
15358465
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.
Results Reference
background
PubMed Identifier
7739706
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.
Results Reference
background
PubMed Identifier
17291207
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.
Results Reference
background
PubMed Identifier
31867375
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.
Results Reference
background
PubMed Identifier
2197679
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.
Results Reference
background
PubMed Identifier
31221931
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.
Results Reference
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Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome

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