Dysmenorrhea PrimaryNCT06738212
Comparative Effects of Aerobic and Aviva Exercises in Primary Dysmenorrhea
A study testing Group A aerobic exercises and Group B Aviva exercises in people with Dysmenorrhea Primary, run by Riphah International University at 1 site in Pakistan.
Trial summary
Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. Primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Group A aerobic exercises and Group B Aviva exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2024to 1 Mar 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unmarried females
- Regular menstrual cycles (every 21-35 days)
- Moderate to severe menstrual cramp pain
Who cannot join
- Pelvic pathology (endometriosis, chronic pelvic inflammatory disease, adenomyosis)
- History of pelvic surgery or inflammatory disease
- Chronic pain or pain disorders (e.g., fibromyalgia)
- Current use of pain medication or muscle relaxants
- History of mental health disorders (e.g., depression, anxiety)
- Inability to understand or complete study assessments
- Any underlying medical condition that may be contributing to dysmenorrhea (e.g., thyroid disorders, kidney disease)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sharif Medical Complex & Kasrat gym
Lahore, Punjab Province, 6400
About this study
Official title: Comparative Effects of Aerobic and Aviva Exercises on Pain Quality of Life, Sleep and Daily Functioning in Primary Dysmenorrhea
Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. Primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. However, it can affect the quality of life of women and cause inability to carry out daily functioning consequently, absence from school or workplace. Exercise is one of the non-conservative methods to reduce the severity of primary dysmenorrhea. The aim of this study is to compare the effects of aerobic and Aviva exercises on primary dysmenorrhea. This study emphasizes the importance of aerobic exercises and Aviva exercise to reduce the severity of primary Dysmenorrhea. This will help in patients over all recovery and will improve general well-being.
This will be a Randomized clinical trial conducted on 42 participants. The data will be collected from Sharif Medical Complex and Kasrat Gym Lake City by using non-probability convenience sampling technique. Patients with primary dysmenorrhea diagnosed with Walid score questionnaire of age 20-40 will be included. A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises. Participants will be assessed using the Mc Gill pain questionnaire for pain, women health initiative insomnia rating scale will be used for sleep, and brief pain inventory short form for daily functioning and Quality of life enjoyment and satisfaction questionnaire short form for quality of life. Data will be analyzed by using SPSS version 26.0.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Group A aerobic exercises, Group B Aviva exercises
- Keywords
- Exercise, Quality of life, Sleep, Pain
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A aerobic exercisesOther
Group A will perform the aerobic exercises (such as bicycling, treadmill and running) Aerobic exercises 15min/session for each exercise, 2 times/week. Frequency: 2 times /week Intensity: Easy to moderate about 60 to 75% of maximum heart rate Type: treadmill, bicycling, running Time: 45min/session
Bicycling:
15
- Start with gentle, low-intensity cycling and gradually increase as comfort allows - Aim for regular, consistent cycling sessions (e.g., 2-3 times a week,15min/session) - Consider incorporating other exercises, like stretching or yoga, to complement cycling.
Running
To get started with running for dysmenorrhea:
- Start with short distances and gradually increase as comfort allows
- Aim for regular, consistent running sessions (e.g., 2-3 times a week,15 minute/session)
- Consider incorporating other exercises, like stretching or yoga, to complement running.
Group B Aviva exercisesOther
Group B will perform the Aviva exercises in 18 different movements. Aviva exercise intervention method is based on a carefully structured, mild-to-moderate intensity series of 18 movement sequences and aerobic exercises 30min/session, 2 times/week (20)
Aviva Methods of exercises:
These exercises are a carefully structured, intense, and methodical series of movement sequences, including a 5 min warm-up exercise at the beginning and 5 min cooling-down exercises at the end of the session. These exercises are performed in Standing, Sitting, Supine lying, prone lying
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercises | Experimental | Not described Receives: Other: Group A aerobic exercises |
| Aviva Exercises | Active comparator | Not described Receives: Other: Group B Aviva exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mc Gill Pain Questionnaire
The Mc Gill pain questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.
Validity and reliability 0.79 and 0.89.
Measured: 12 weeks
Women's Health Initiative Insomnia Rating Scale (WHIIRS)
A brief five-item scale evaluating insomnia symptoms, the WHIIRS was developed as part of a larger study investigating a range of health issues affecting postmenopausal women. The scale requires individuals to rate the quality of their sleep and the frequency with which they experience certain sleep problems, providing a total score that may be useful for both research and clinical purposes.
Measured: 12 weeks
Brief Pain Inventory Short Form SF 12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is given the bidirectional link between sleep and pain. The range of the scale from 0 to 10.the internal reliability ranging from .95 to .97 for surgical cancer and .82 to .95 ranging for patient with low back pain and arthritis. It is often used as a quality-of-life measure.
Measured: 12 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form(Q-LES-Q-SF)
Quality of life Enjoyment and Satisfaction Questionnaire Short form evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start30 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738212
- Sponsor's protocol ID
- Riphah international universit
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anis T, Hasan S, Lohana N, Salahuddin I, Saeed HJJoXaSU, Natural Sciences Edition. Effects of aerobic program on the severity of dysmenorrhea using WaLIDD score. 2023;19(6):550-4
Kovacs Z, Atombosiye E, Hegyi G, Szoke H. The Effect of Aviva Exercise Intervention on Pain Level and Body Awareness in Women with Primary Dysmenorrhea. Medicina (Kaunas). 2024 Jan 20;60(1):184. doi: 10.3390/medicina60010184.
PubMed 38276063Elbandrawy AM, Elhakk SM. Comparison between the effects of aerobic and isometric exercises on primary dysmenorrhea. 2021
Gohil K, Mehta B. Effect of aerobic exercise on pain and quality of life in women with primary dysmenorrhea. International Journal of Applied Research. 2022;8(6):256-8
Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.
PubMed 29855308
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic and Aviva Exercises on Pain Quality of Life, Sleep and Daily Functioning in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06738212
- Acronym / sponsor ID
- Riphah international universit
- Conditions
- Dysmenorrhea Primary
- Keywords
- Exercise, Quality of life, Sleep, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. Primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. However, it can affect the quality of life of women and cause inability to carry out daily functioning consequently, absence from school or workplace. Exercise is one of the non-conservative methods to reduce the severity of primary dysmenorrhea. The aim of this study is to compare the effects of aerobic and Aviva exercises on primary dysmenorrhea. This study emphasizes the importance of aerobic exercises and Aviva exercise to reduce the severity of primary Dysmenorrhea. This will help in patients over all recovery and will improve general well-being.
This will be a Randomized clinical trial conducted on 42 participants. The data will be collected from Sharif Medical Complex and Kasrat Gym Lake City by using non-probability convenience sampling technique. Patients with primary dysmenorrhea diagnosed with Walid score questionnaire of age 20-40 will be included. A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises. Participants will be assessed using the Mc Gill pain questionnaire for pain, women health initiative insomnia rating scale will be used for sleep, and brief pain inventory short form for daily functioning and Quality of life enjoyment and satisfaction questionnaire short form for quality of life. Data will be analyzed by using SPSS version 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A sample will be divided into two groups, each group will have 21 participants. The group A will be given Aerobic exercise and Group B will be given Aviva exercises.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercises | Experimental | Other: Group A aerobic exercises |
| Aviva Exercises | Active comparator | Other: Group B Aviva exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unmarried females
- Regular menstrual cycles (every 21-35 days)
- Moderate to severe menstrual cramp pain
Key exclusion criteria (7 listed)
- Pelvic pathology (endometriosis, chronic pelvic inflammatory disease, adenomyosis)
- History of pelvic surgery or inflammatory disease
- Chronic pain or pain disorders (e.g., fibromyalgia)
- Current use of pain medication or muscle relaxants
- History of mental health disorders (e.g., depression, anxiety)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A aerobic exercisesGroup A will perform the aerobic exercises (such as bicycling, treadmill and running) Aerobic exercises 15min/session for each exercise, 2 times/week. Frequency: 2 times /week Intensity: Easy to moderate about 60 to 75% of maximum heart rate Type: treadmill, bicycling, running Time: 45min/session Bicycling: 15 - Start with gentle, low-intensity cycling and gradually increase as comfort allows - Aim for regular, consistent cycling sessions (e.g., 2-3 times a week,15min/session) - Consider incorporating other exercises, like stretching or yoga, to complement cycling. Running To get started with running for dysmenorrhea: 1. Start with short distances and gradually increase as comfort allows 2. Aim for regular, consistent running sessions (e.g., 2-3 times a week,15 minute/session) 3. Consider incorporating other exercises, like stretching or yoga, to complement running. | Other | Aerobic Exercises |
| Group B Aviva exercisesGroup B will perform the Aviva exercises in 18 different movements. Aviva exercise intervention method is based on a carefully structured, mild-to-moderate intensity series of 18 movement sequences and aerobic exercises 30min/session, 2 times/week (20) Aviva Methods of exercises: These exercises are a carefully structured, intense, and methodical series of movement sequences, including a 5 min warm-up exercise at the beginning and 5 min cooling-down exercises at the end of the session. These exercises are performed in Standing, Sitting, Supine lying, prone lying | Other | Aviva Exercises |
Primary outcome
Mc Gill Pain Questionnaire
Time frame: 12 weeks
The Mc Gill pain questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. Validity and reliability 0.79 and 0.89.
Women's Health Initiative Insomnia Rating Scale (WHIIRS)
Time frame: 12 weeks
A brief five-item scale evaluating insomnia symptoms, the WHIIRS was developed as part of a larger study investigating a range of health issues affecting postmenopausal women. The scale requires individuals to rate the quality of their sleep and the frequency with which they experience certain sleep problems, providing a total score that may be useful for both research and clinical purposes.
Brief Pain Inventory Short Form SF 12
Time frame: 12 weeks
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is given the bidirectional link between sleep and pain. The range of the scale from 0 to 10.the internal reliability ranging from .95 to .97 for surgical cancer and .82 to .95 ranging for patient with low back pain and arthritis. It is often used as a quality-of-life measure.
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form(Q-LES-Q-SF)
Time frame: 12 weeks
Quality of life Enjoyment and Satisfaction Questionnaire Short form evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- BackgroundAnis T, Hasan S, Lohana N, Salahuddin I, Saeed HJJoXaSU, Natural Sciences Edition. Effects of aerobic program on the severity of dysmenorrhea using WaLIDD score. 2023;19(6):550-4
- Background: PubMed 38276063Kovacs Z, Atombosiye E, Hegyi G, Szoke H. The Effect of Aviva Exercise Intervention on Pain Level and Body Awareness in Women with Primary Dysmenorrhea. Medicina (Kaunas). 2024 Jan 20;60(1):184. doi: 10.3390/medicina60010184.
- BackgroundElbandrawy AM, Elhakk SM. Comparison between the effects of aerobic and isometric exercises on primary dysmenorrhea. 2021
- BackgroundGohil K, Mehta B. Effect of aerobic exercise on pain and quality of life in women with primary dysmenorrhea. International Journal of Applied Research. 2022;8(6):256-8
- Background: PubMed 29855308Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hina gul, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A aerobic exercises and Group B Aviva exercises in people with Dysmenorrhea Primary, 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 3 inclusion and 7 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 25 Feb 2026. 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?
Mc Gill Pain Questionnaire (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT06738212, which also lists 5 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 25 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.