Primary DysmenorrheaNCT05258253
Effects of HIA and PCE in Primary Dysmenorrhea
A study testing High intensity aerobics and Pelvic clock exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea. Read more about this study
- Who is it for?
- Ages 17 to 24 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- High intensity aerobics and Pelvic clock exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Feb 2021to 13 Nov 2021
- 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 17 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Girls aged 17-23 years with regular menstrual cycle
- Unmarried girls
Who cannot join
- Athletes, Married women,
- Girls who were regularly exercising
- Having any pelvic pathology, abnormal menstrual cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Aerobics and Pelvic Clock Exercises in Primary Dysmenorrhea
The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.
Read the detailed description
There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. Although there are many researches on high intensity aerobics.Previous researches only have lierature about aerobics.So to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- High intensity aerobics, Pelvic clock exercises
- Keywords
- high intensity aerobics, primary dysmenorrhea, aerobics, painful menstruation
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobicsOther
"London bridges (8mins)" "Jumping lunges(8mins)" "Mountain climbers(8mins)" "Quadruped bent knee hip extension (8mins)"
Pelvic clock exercisesOther
Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock.
| Study group | Role | What they receive |
|---|---|---|
| high intensity aerobics | Experimental | "London bridges (8mins)","Jumping lunges(8mins)","Mountain climbers(8mins)","Quadruped bent knee hip extension (8mins)" Receives: Other: High intensity aerobics |
| pelvic clock exercises | Active comparator | Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock. Receives: Other: Pelvic clock exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Scores are recorded by making a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: last 1 day
Secondary outcomes (1)
DASS 21
DASS-21 scale contains 7 items, divided into subscales with similar content.
Measured: last 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start8 Feb 2021
- Primary completion13 Jul 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258253
- Sponsor's protocol ID
- REC/Lhr/21/0505 Asmaa Qamar
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Aerobics and Pelvic Clock Exercises in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05258253
- Acronym / sponsor ID
- REC/Lhr/21/0505 Asmaa Qamar
- Conditions
- Primary Dysmenorrhea
- Keywords
- high intensity aerobics, primary dysmenorrhea, aerobics, painful menstruation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 28 Feb 2022 (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.
The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.
Detailed description
There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. Although there are many researches on high intensity aerobics.Previous researches only have lierature about aerobics.So to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity aerobics | Experimental | Other: High intensity aerobics"London bridges (8mins)","Jumping lunges(8mins)","Mountain climbers(8mins)","Quadruped bent knee hip extension (8mins)" |
| pelvic clock exercises | Active comparator | Other: Pelvic clock exercisesLie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Girls aged 17-23 years with regular menstrual cycle
- Unmarried girls
Key exclusion criteria (3 listed)
- Athletes, Married women,
- Girls who were regularly exercising
- Having any pelvic pathology, abnormal menstrual cycle.
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 |
|---|---|---|
| High intensity aerobics"London bridges (8mins)" "Jumping lunges(8mins)" "Mountain climbers(8mins)" "Quadruped bent knee hip extension (8mins)" | Other | high intensity aerobics |
| Pelvic clock exercisesLie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock. | Other | pelvic clock exercises |
Primary outcome
Visual analogue scale
Time frame: last 1 day
Scores are recorded by making a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
1 secondary outcome
DASS 21
Time frame: last 1 day
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 28 Feb 2022.
- 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.
Sara Aabroo, PPDPT 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 High intensity aerobics and Pelvic clock exercises 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 2 inclusion and 3 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 Feb 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?
Visual analogue scale (time frame: last 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2022.