NCT05697536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

January 4, 2023

Last Update Submit

June 14, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    8th week

  • 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.

    8th week

  • 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.

    8th week

Study Arms (2)

Pilates training

EXPERIMENTAL

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.

Other: Pilates training

Aerobic exercise

EXPERIMENTAL

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.

Other: Aerobic Exercise

Interventions

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.

Pilates training

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

Aerobic exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unmarried
  • Age between 18-30 years
  • Patients with at least 5 of 11 symptoms on premenstrual syndrome questionnaire

You may not qualify if:

  • Patients suffering from Any Disability.
  • Patients suffering from diabetes or hypertension or any other Chronic Illness.
  • Spine fracture or history of Any Previous Surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.

    PMID: 12725453BACKGROUND
  • 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.

    PMID: 23983722BACKGROUND
  • 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.

    PMID: 33246104BACKGROUND
  • 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.

    PMID: 27807531BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Exercise Movement TechniquesExercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adeela Arif, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 26, 2023

Study Start

January 15, 2022

Primary Completion

February 25, 2023

Study Completion

March 15, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations