Effect of HIIT VS Yoga on Level of Pain, Catastrophizing and QoL in Dysmenorrhea

November 24, 2022 updated by: Riphah International University

Effect of High Intensity Interval Training Versus Yoga on Level of Pain, Catastrophizing and Quality of Life Among Females With Dysmenorrhea

This study is aimed at determining the effect of high intensity interval training VS yoga on pain, catastrophizing and quality of life among young females with dysmenorrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dysmenorrhea is defined as a pain experienced by females before or during menstruation and it is a common and important gynecological condition found in females of reproductive age that adversely affects their quality of life. The cause of PD is believed to be the excess release of prostaglandins during normal ovulation cycle.

The health care costs were altogether higher among females with dysmenorrhea compared with females who didn't experience the ill effects of this condition, and excess costs were essentially determined by outpatient care, so poses greater burden of disease than any other gynecological complaint. Females having more pain catastrophizing scores leads to increases chances of disability. Proper evidence behind HIIT training among females with primary dysmenorrhea is sparse and is based on different clinical experiences and a less number of studies with limited methodological design.

Study Type

Interventional

Enrollment (Actual)

34

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

  • Pakistan
    • Fedral
      • Rawalpindi, Fedral, Pakistan, 44000
        • Railway General Hospital

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

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Unmarried Females with age 18-25 years
  • Normal Menstrual cycles 21-35 days
  • Primary Dysmenorrhea diagnosis made on the WaLIDD score
  • WaLIDD score of 1- 7 (Mild to moderate dysmenorrhea)

Exclusion Criteria:

  • History of regular exercise (3 times weekly for 30-45 min)
  • Motor Disabilities ( ALS, Multiple sclerosis, Muscular dystrophy )
  • Autoimmune conditions (RA, Hashimotos Thyroiditis)
  • Chronic illnesses that might contraindicate physical exercise (asthma, epilepsy, migraine, anemia, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension)

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High intensity interval training
High intensity interval training will be administered three days a week for 8 weeks. six series with 3 minutes rest period between series. For first 4 weeks the series would consist of 30 seconds of exercise and 30 seconds rest. exercises will consist of burpees, skipping, lunges, 1-legged squat, leg lever, push ups. for next four weeks the duration of exercise will be 45 seconds followed by 30 seconds recovery.
Other: High intensity interval training

HIIT 3 times a week for 8 weeks. For week 1 to 4 , Warm up 5 minutes jogging in place, 6 series of 30 seconds Burpees, 30 seconds recovery, 30 seconds skipping, 30 seconds recovery, 30 seconds lunge, 30 seconds recovery, 30 seconds 1-legged squats, 30 seconds recovery, 30 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches.

For week 5 to 8 , Warm up 5 minutes jogging in place, 6 series of 45 seconds Burpees, 45 seconds recovery, 45 seconds skipping, 30 seconds recovery, 45 seconds lunge, 30 seconds recovery, 45 seconds 1-legged squats, 30 seconds recovery, 45 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches.
ACTIVE_COMPARATOR: Yoga Training
Yoga will be administered 3 days a week for 8 weeks. the session would be of 30-50 minutes with 5 minutes breathing followed by 15-35 minutes yoga and 10 minutes supine meditation. cat-cow stretch, child's pose, downward dog, plank, cobra pose will be used.
Other: Yoga Training
Yoga 3 times a week for 8 weeks. 30-50 minutes session, 5 minutes breathing, 15-35 minutes yoga poses (Cat-cow, child's pose, downward dog, plank, Cobra), followed by 10 minutes supine meditation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: 8th week
changes from baseline The numeric pain rating scale (NPRS) is a 10 points scale on which, zero represent no pain, 1 to 3 represent mild pain, 4 to 7 represent moderate and pain score between 7 and 10 were considered to be a severe form of pain.[
8th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain catastrophizing
Time Frame: 8th week
The 13-item scale measures the extent to which participants worry, amplify, and feel helpless about the experience of pain on a five-point (0-4) scale. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
8th week
EQ-5D for quality of life
Time Frame: 8th week
The EQ-5D is an acceptable, reliable and valid measure of quality of life. The EQ-5D, a standardized questionnaire consists of two parts: the first is the 'EQ-5D descriptive system' with five questions about several dimensions of HrQoL (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). Each dimension can be rated at three levels: 'no problems', 'some problems' and 'major problems'. The responses to the five dimensions together lead to an aggregated index, the 'EQ-5D index', which corresponds to a health state. The second part of the scale is the 'EQ Visual Analogic Scale' (EQVAS) which is the respondent's own assessment of her overall health status on a thermometer-like visual scale.
8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (ACTUAL)

August 25, 2022

Study Completion (ACTUAL)

August 25, 2022

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (ACTUAL)

August 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01098 Areeba Aamir

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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