- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811455
Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain and Quality of Life
April 12, 2023 updated by: Riphah International University
Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain,Anxiety and Quality of Life
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles.
As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation.
Around 10% to 53% of female adults suffer from this condition.
This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important.
Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies.
However, these two interventions have never been compared to test their effects on pain, and functional performance.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Johar Institute of Professional Studies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18 to 40 years
- Females in their last week of the luteal phase (1 week before menstruation)
- Females with regular menstrual with equal intervals between 21 and 35 days
- Females with a score of 133 and above after being screened with Premenstrual syndrome scale
- Females suffering from PMS for at least the past six months
Exclusion Criteria:
- Females with the irregular menstrual cycle
- Pregnant females
- Menstruating females or females in the follicular or ovulatory phase
- History of physical exercise in the past three months before the beginning of the study
- Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: aerobic exercises.
The first treatment group will be given aerobic exercises for six weeks at least three times per week.
This group will include 14 participants.
This study group will be assigned with basic treatment protocol with aerobic exercises along with 10 minutes of warm up period.
|
To compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome
|
|
Active Comparator: group b progressive muscle relaxation exercises.
The intervention will be given three days per week for six weeks. Pre and post-treatment readings will be noted. Each total session will last for 45 minutes. The importance of the study will be explained, and consent will be taken from the people before the intervention will be applied.
|
progressive muscle relaxation exercises.
|
|
No Intervention: Group C. Control group
No intervention was given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time Frame: 6 weeks
|
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.(16)
|
6 weeks
|
|
Numerical rating scales (NRSs)
Time Frame: 6 weeks
|
Numerical rating scales (NRSs) are the simplest and most commonly used scale.
The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable
|
6 weeks
|
|
• SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36)
Time Frame: 6 weeks
|
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatima Tariq, Mphill, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR & AHS/22/054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
Clinical Trials on Aerobic exercises
-
University of Sao Paulo General HospitalCompleted
-
Cairo UniversityActive, not recruiting
-
Çankırı Karatekin UniversityHacettepe UniversityCompleted
-
University of HailCompleted
-
Istanbul Medipol University HospitalCompletedCognitive Function 1, SocialTurkey
-
Prince Sattam Bin Abdulaziz UniversityCompletedHealth, SubjectiveSaudi Arabia
-
Riphah International UniversityCompletedDepression | Sleep Quality | Primigravida FemalesPakistan
-
Ankara City Hospital BilkentRecruitingAxial Spondyloarthritis and Ankylosing SpondylitisTurkey
-
Istanbul UniversityCompletedFibromyalgia | Fibromyalgia Syndrome | Fibromyalgia (FM)Turkey (Türkiye)
-
Instituto Politécnico de Castelo BrancoCompleted