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

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.

  • Breathe in, and tense the first muscle group (hard but not to the point of pain or cramping) for 4 to 10 seconds.
  • Breathe out, and suddenly and completely relax the muscle group (do not relax it gradually) (20)
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.

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.

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