Premenstrual SyndromeNCT05834127
Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome
A study testing Aerobic exercise and Yoga Exercises in people with Premenstrual Syndrome and Pain, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Pain
- What is being tested?
- Aerobic exercise and Yoga Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome
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.
Read the 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.
- Conditions
- Premenstrual Syndrome, Pain
- Being tested
- Aerobic exercise, Yoga Exercises
- Keywords
- Aerobic exercises, Menstruation, Premenstrual syndrome, Visual analogue scale, Yoga
- Medical subject headings
- Premenstrual Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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 ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Yoga Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Nov 2022
- Primary completion30 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834127
- Sponsor's protocol ID
- REC/RCR & AHS/23/0508
- Status last verified
- Dec 2023
- First submitted
- 18 Apr 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24701496Derman 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.
PubMed 15358465Steiner 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.
PubMed 7739706Chen 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.
PubMed 17291207Vaghela 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.
PubMed 31867375Wewers 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.
PubMed 2197679Ghaffarilaleh 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.
PubMed 31221931
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT05834127
- Acronym / sponsor ID
- REC/RCR & AHS/23/0508
- Conditions
- Premenstrual Syndrome, Pain
- Keywords
- Aerobic exercises, Menstruation, Premenstrual syndrome, Visual analogue scale, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: Aerobic exerciseGroup A will receive aerobic exercises. Treatment will be given 3 times a week for 1 month. Total number of sessions will be 12 |
| Yoga exercises | Active comparator | Other: Yoga ExercisesGroup 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 |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseGroup 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 | Other | Aerobic exercises |
| Yoga ExercisesGroup 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 | Other | Yoga exercises |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 24701496A 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.
- Background: PubMed 15358465Derman 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.
- Background: PubMed 7739706Steiner 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.
- Background: PubMed 17291207Chen 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.
- Background: PubMed 31867375Vaghela 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.
- Background: PubMed 2197679Wewers 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.
- Background: PubMed 31221931Ghaffarilaleh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Arshad, M.phil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Yoga Exercises in people with Premenstrual Syndrome and Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834127, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.