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Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pilates training
Aerobic Exercise
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Riphah International university, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pilates training

Aerobic exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
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.
Anxiety
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.
WHO quality of life questionnaire
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05697536
Brief Title
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS
Official Title
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and Quality of Life in Premenstrual Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

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
The significance of this study is that it may improve the premenstrual symptoms like pain and anxiety in females with premenstrual syndrome and improve their quality of life. This study may add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy. Therefore, the study will be done to compare the effects of Pilate exercises and aerobic exercises on pain, anxiety and quality of life in females with premenstrual syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pilates training
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
8th week
Title
Anxiety
Description
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.
Time Frame
8th week
Title
WHO quality of life questionnaire
Description
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.
Time Frame
8th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeela Arif, Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International university, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12725453
Citation
Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
Results Reference
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PubMed Identifier
23983722
Citation
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.
Results Reference
background
PubMed Identifier
33246104
Citation
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.
Results Reference
background
PubMed Identifier
27807531
Citation
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.
Results Reference
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Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS

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