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

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity interval training
Yoga Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring yoga, dysmenorrhea, Pain, catastrophizing, exercise

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity interval training

Yoga Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric pain rating scale
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.[

Secondary Outcome Measures

Pain catastrophizing
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.
EQ-5D for quality of life
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.

Full Information

First Posted
August 11, 2021
Last Updated
November 24, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05010967
Brief Title
Effect of HIIT VS Yoga on Level of Pain, Catastrophizing and QoL in Dysmenorrhea
Official Title
Effect of High Intensity Interval Training Versus Yoga on Level of Pain, Catastrophizing and Quality of Life Among Females With Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 25, 2022 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
yoga, dysmenorrhea, Pain, catastrophizing, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
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.
Arm Title
Yoga Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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.[
Time Frame
8th week
Secondary Outcome Measure Information:
Title
Pain catastrophizing
Description
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.
Time Frame
8th week
Title
EQ-5D for quality of life
Description
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.
Time Frame
8th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study is focused on females with dysmenorrhea.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Ehsan, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of HIIT VS Yoga on Level of Pain, Catastrophizing and QoL in Dysmenorrhea

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