- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697536
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and Quality of Life in Premenstrual Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Unmarried
- Age between 18-30 years
- Patients with at least 5 of 11 symptoms on premenstrual syndrome questionnaire
Exclusion Criteria:
- Patients suffering from Any Disability.
- Patients suffering from diabetes or hypertension or any other Chronic Illness.
- Spine fracture or history of Any Previous Surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates training
Group A will receive Pilates training.
The treatment will be given with the frequency of 3 times per week for 8 weeks.
Treatment sessions will be of 45 minutes with short resting intervals.
|
It consists of patients who will receive pilates exercise training sessions 3 times per week for 8 weeks. Every session will be of 45 minutes. Exercise programs follow the basic principles of pilates method but particularly movements with low and medium difficulty levels will be chosen to adapt the program to the physical capacity of the patients. Protocol will be compromise of 9 modules: postural education, search for neutral position, sitting exercise, antalgic exercise, stretching exercises, proprioceptively improvement exercises and breathing exercises. |
Experimental: Aerobic exercise
Group B will receive aerobic exercise plan.
The frequency of treatment will be as same as that of Pilates exercise program i.e. 3 times a week for 8 weeks.
Treatment sessions will be of 45 minutes with short resting intervals.
|
It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 45 minutes. It will include warm up phase, active phase and |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 8th week
|
The Numerical pain rating scale is the most commonly used pain scale in the health care. This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10. 0 means no pain and 10 worst pain. |
8th week
|
Anxiety
Time Frame: 8th week
|
DASS-21 is a self reported questionnaire which is used to assess the severity of range of symptoms like depression, anxiety and stress.
It is not only used to measure the severity of symptoms but can also be used to assess the subject's response to treatment.
Less the scores mean less anxiety and more the score means severe anxiety.
|
8th week
|
WHO quality of life questionnaire
Time Frame: 8th week
|
WHO inventiveness to develop a quality of life assessment arises from a requirement for a genuinely international measure of quality of life and a commitment to the continued promotion of an holistic approach to health and health care.
Its developmental process consisted of several stages.
|
8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeela Arif, Mphil, Riphah International University
Publications and helpful links
General Publications
- Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
- Samadi Z, Taghian F, Valiani M. The effects of 8 weeks of regular aerobic exercise on the symptoms of premenstrual syndrome in non-athlete girls. Iran J Nurs Midwifery Res. 2013 Jan;18(1):14-9.
- Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
- Roh SY. Effect of a 16-week Pilates exercise program on the ego resiliency and depression in elderly women. J Exerc Rehabil. 2016 Oct 31;12(5):494-498. doi: 10.12965/jer.1632704.352. eCollection 2016 Oct.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adeela Arif
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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