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Primary DysmenorrheaNCT05010967

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

A study testing High intensity interval training and Yoga Training in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Primary Dysmenorrhea
What is being tested?
High intensity interval training and Yoga Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
1 Aug 2021to 25 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Railway General Hospital

    Rawalpindi, Fedral, 44000

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
High intensity interval training, Yoga Training
Keywords
yoga, dysmenorrhea, Pain, catastrophizing, exercise
Medical subject headings
Dysmenorrhea, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity interval trainingOther

    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 TrainingOther

    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.

Study groups in NCT05010967
Study groupRoleWhat they receive
High intensity interval trainingExperimentalHigh 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.
Receives: Other: High intensity interval training
Yoga TrainingActive comparatorYoga 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.
Receives: Other: Yoga Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.[

    Measured: 8th week

Secondary outcomes (2)
  1. 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.

    Measured: 8th week

  2. 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.

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start1 Aug 2021
  3. Primary completion25 Aug 2022
  4. Study completion25 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010967
Sponsor's protocol ID
REC/01098 Areeba Aamir
Status last verified
Nov 2022
First submitted
11 Aug 2021
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30096156
  • 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.

    PubMed 28579813
  • 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.

    PubMed 31539615
  • Aubry G, Panel P, Thiollier G, Huchon C, Fauconnier A. Measuring health-related quality of life in women with endometriosis: comparing the clinimetric properties of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D). Hum Reprod. 2017 Jun 1;32(6):1258-1269. doi: 10.1093/humrep/dex057.

    PubMed 28383700
  • 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.

    PubMed 33822197
  • 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.

    PubMed 27315239
  • 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.

    PubMed 29037637
  • 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.

    PubMed 29902363
  • 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.

  • 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.

    PubMed 28420999
  • 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-α in woman with primary dysmenorrhea," Res. Med., vol. 41, no. 4, pp. 258--268, 2017

  • 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.

    PubMed 29867519
  • 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.

    PubMed 32415471
  • 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.

    PubMed 31071464

Questions about this trial

What is this clinical trial studying?

A study testing High intensity interval training and Yoga Training in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric pain rating scale (time frame: 8th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010967, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.

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