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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010967
• Other study ID #: REC/01098 Areeba Aamir
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: November 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Railway General Hospital	Rawalpindi	Fedral

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (23)

Akiyama S, Tanaka E, Cristeau O, Onishi Y, Osuga Y. Evaluation of the treatment patterns and economic burden of dysmenorrhea in Japanese women, using a claims database. Clinicoecon Outcomes Res. 2017 May 22;9:295-306. doi: 10.2147/CEOR.S127760. eCollection 2017. — View Citation

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B. S. M. Ameade, EP Kwuame, "Menstrual pain assessment: comparing verbal rating scale (VRS) with numerical rating scales (NRS) as pain measurement tools," 2016

Chen CX, Carpenter JS, LaPradd M, Ofner S, Fortenberry JD. Perceived Ineffectiveness of Pharmacological Treatments for Dysmenorrhea. J Womens Health (Larchmt). 2021 Sep;30(9):1334-1343. doi: 10.1089/jwh.2020.8581. Epub 2020 Oct 7. — View Citation

Durand H, Monahan K, McGuire BE. Prevalence and Impact of Dysmenorrhea Among University Students in Ireland. Pain Med. 2021 Dec 11;22(12):2835-2845. doi: 10.1093/pm/pnab122. — View Citation

Fernandez-Martinez E, Onieva-Zafra MD, Parra-Fernandez ML. Lifestyle and prevalence of dysmenorrhea among Spanish female university students. PLoS One. 2018 Aug 10;13(8):e0201894. doi: 10.1371/journal.pone.0201894. eCollection 2018. — View Citation

Heidarimoghadam R, Abdolmaleki E, Kazemi F, Masoumi SZ, Khodakarami B, Mohammadi Y. The Effect of Exercise Plan Based on FITT Protocol on Primary Dysmenorrhea in Medical Students: A Clinical Trial Study. J Res Health Sci. 2019 Aug 24;19(3):e00456. — View Citation

Hu Z, Tang L, Chen L, Kaminga AC, Xu H. Prevalence and Risk Factors Associated with Primary Dysmenorrhea among Chinese Female University Students: A Cross-sectional Study. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):15-22. doi: 10.1016/j.jpag.2019.09.004. Epub 2019 Sep 17. — View Citation

J. R. Rahimi, Niloofar, Effat Bambaiechi, "Comparison the effect of eight weeks high intensity interval and moderate continuous trainings on pain reductionand and blood levels of IL6 and TNF-a in woman with primary dysmenorrhea," Res. Med., vol. 41, no. 4, pp. 258--268, 2017

Kannan P, Chapple CM, Miller D, Claydon-Mueller L, Baxter GD. Effectiveness of a treadmill-based aerobic exercise intervention on pain, daily functioning, and quality of life in women with primary dysmenorrhea: A randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:80-86. doi: 10.1016/j.cct.2019.05.004. Epub 2019 May 7. — View Citation

Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15. — View Citation

McGovern CE, Cheung C. Yoga and Quality of Life in Women with Primary Dysmenorrhea: A Systematic Review. J Midwifery Womens Health. 2018 Jul;63(4):470-482. doi: 10.1111/jmwh.12729. Epub 2018 Jun 14. — View Citation

P. Guruprasad, Padmaja and Sharma, Urvashi and Palekar, Tushar and Pimpri, "Immediate Effect of Yoga Postures v/s Physiotherapy Exercises Along With KTaping on Pain in Dysmenorrhea," 2019.

P. Prabhu, Shraddha and Nagrale, Sanket and Shyam, Ashok and Sancheti, "Effect of yogasanas on menstrual cramps in young adult females with primary dysmenorrhea," Int J Physiother Res, vol. 7, no. 4, pp. 3109--3112, 2019.

Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):192-6. doi: 10.1016/j.jpag.2011.01.059. Epub 2011 Apr 21. — View Citation

S. Atashak, Sirvan and Rashidi, "Effect of eight-week high-intensity interval training and ginger supplementation on primary dysmenorrhea in nonathletic female students," Iran. J. Obstet. Gynecol. Infertil., vol. 20, no. 12, pp. 23--31, 2018.

S. I. and others Aiyegbusi, Ayoola Ibifubara and Adeagbo, Caleb Adewunmi and Uwem-Umoh, "Comparative efficacy of core strengthening and stretching exercises on systemic and quality-of-life symptoms in adolescent college students with primary dysmenorrhea," New Niger. J. Clin. Res., vol. 9, no. 16, p. 59, 2020.

Sperlich B, Hahn LS, Edel A, Behr T, Helmprobst J, Leppich R, Wallmann-Sperlich B, Holmberg HC. A 4-Week Intervention Involving Mobile-Based Daily 6-Minute Micro-Sessions of Functional High-Intensity Circuit Training Improves Strength and Quality of Life, but Not Cardio-Respiratory Fitness of Young Untrained Adults. Front Physiol. 2018 May 9;9:423. doi: 10.3389/fphys.2018.00423. eCollection 2018. — View Citation

Sperlich B, Wallmann-Sperlich B, Zinner C, Von Stauffenberg V, Losert H, Holmberg HC. Functional High-Intensity Circuit Training Improves Body Composition, Peak Oxygen Uptake, Strength, and Alters Certain Dimensions of Quality of Life in Overweight Women. Front Physiol. 2017 Apr 3;8:172. doi: 10.3389/fphys.2017.00172. eCollection 2017. — View Citation

T. N. Ouda, Khalil, Sameh Latif, "A study of the effect of heat application on relieving dysmenorrheal pain among young females," African J. Nurs. Midwifery, vol. 5, no. 6, pp. 727-735, 2017.

Tsai SY. Effect of Yoga Exercise on Premenstrual Symptoms among Female Employees in Taiwan. Int J Environ Res Public Health. 2016 Jul 16;13(7):721. doi: 10.3390/ijerph13070721. — View Citation

Yang NY, Kim SD. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016 Sep;22(9):732-8. doi: 10.1089/acm.2016.0058. Epub 2016 Jun 17. — View Citation

Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.[	8th week
Secondary	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.	8th week
Secondary	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.	8th week