Dysmenorrhea PrimaryNCT06129708
Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females
A study testing Aquatic Exercise and Aerobic Exercise in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to determine the difference between impact of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls. Read more about this study
- Who is it for?
- Ages 14 to 20 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Aquatic Exercise and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Oct 2023
- 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 14 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy, nonsmoking, virginal girls having moderate to severe primary dysmenorrhea (score on pain rating scale > 3).
- Their ages ranged from 14 to 20 years
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They haven't practice any sports at least one year
Who cannot join
- Any musculoskeletal disorder.
- Cardio-respiratory disease.
- Diabetes, hypertension, or anemia.
- Adolescent girls who have utilized hormonal treatment in the six months prior to study commencement.
- currently undergoing pharmacological therapy for menstrual pain management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females: A Randomized Controlled Trial
This study was conducted to determine the difference between impact of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
Read the detailed description
Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was significantly more frequent in students from rural residence (Shaimaa et al., 2018).
There is only one previous study investigate effect of aquatic exercise on primary dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of aerobic ex , however non of the previous studies compared between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore this study was the first one which aimed to investigate the difference between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Aquatic Exercise, Aerobic Exercise
- Keywords
- Primary Dysmenorrhea, Adolescent Females, Aquatic Exercise, Aerobic Exercise, Pressure Pain Threshold, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExerciseOther
The aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and
Aerobic ExerciseOther
The exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down. Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill. Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0 Borg scale) for 30 minutes. At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale).
| Study group | Role | What they receive |
|---|---|---|
| Group (A) Aquatic Exercise Group | Experimental | They participated in an aqua aerobic exercise program, 3 days per week, for 8 weeks Receives: Other: Aquatic Exercise |
| Group (B) Aerobic Exercise Group | Experimental | They participated in an aerobic exercise program on a treadmill, 3 days per week, for 8 weeks. Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of dysmenorrhea severity
It was assessed for each participant in the two groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using WaLIDD scale, which has high sensitivity and high specificity.
Measured: 12 weeks
Measurement of pain intensity
It was measured for each participant in both groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using the Arabic version of numeric pain rating scale. The respondents were required to select a number (0-10 integers) that best reflected the intensity of her pain. In the numeric pain rating scale, 0 represented no pain, 1-3 indicated mild pain, 4-6 indicated moderate pain, while 7-10 indicated severe pain.
Measured: 12 weeks
Assessment of pressure pain threshold (PPT)
The PPT was measured for each participant in both groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using a pressure algometry.
Measured: 12 weeks
Assessment of health related quality of life
The health related quality of life of all participants in both groups (A \& B) was evaluated before and after the end of treatment program, using the Arabic version of EQ-5D-3L questionnaire.
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 posted13 Nov 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Yossry Abdelrahman Ahmed, Cairo University
- Investigators
- Sohier M. Elkosery, Prof., Study chair, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129708
- Sponsor's protocol ID
- P.T.REC/012/004770
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelrahman AY, El-Kosery SM, Abbassy AH, Botla AM. Effect of aquatic exercise versus aerobic exercise on primary dysmenorrhea and quality of life in adolescent females: A randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2095. doi: 10.1002/pri.2095.
PubMed 38767193
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06129708
- Acronym / sponsor ID
- P.T.REC/012/004770
- Conditions
- Dysmenorrhea Primary
- Keywords
- Primary Dysmenorrhea, Adolescent Females, Aquatic Exercise, Aerobic Exercise, Pressure Pain Threshold, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Nov 2023 (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.
This study was conducted to determine the difference between impact of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
Detailed description
Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was significantly more frequent in students from rural residence (Shaimaa et al., 2018).
There is only one previous study investigate effect of aquatic exercise on primary dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of aerobic ex , however non of the previous studies compared between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore this study was the first one which aimed to investigate the difference between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) Aquatic Exercise Group | Experimental | Other: Aquatic ExerciseThey participated in an aqua aerobic exercise program, 3 days per week, for 8 weeks |
| Group (B) Aerobic Exercise Group | Experimental | Other: Aerobic ExerciseThey participated in an aerobic exercise program on a treadmill, 3 days per week, for 8 weeks. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy, nonsmoking, virginal girls having moderate to severe primary dysmenorrhea (score on pain rating scale > 3).
- Their ages ranged from 14 to 20 years
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They haven't practice any sports at least one year
Key exclusion criteria (5 listed)
- Any musculoskeletal disorder.
- Cardio-respiratory disease.
- Diabetes, hypertension, or anemia.
- Adolescent girls who have utilized hormonal treatment in the six months prior to study commencement.
- currently undergoing pharmacological therapy for menstrual pain management
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 |
|---|---|---|
| Aquatic ExerciseThe aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and | Other | Group (A) Aquatic Exercise Group |
| Aerobic ExerciseThe exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down. Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill. Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0 Borg scale) for 30 minutes. At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale). | Other | Group (B) Aerobic Exercise Group |
Primary outcome
Assessment of dysmenorrhea severity
Time frame: 12 weeks
It was assessed for each participant in the two groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using WaLIDD scale, which has high sensitivity and high specificity.
Measurement of pain intensity
Time frame: 12 weeks
It was measured for each participant in both groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using the Arabic version of numeric pain rating scale. The respondents were required to select a number (0-10 integers) that best reflected the intensity of her pain. In the numeric pain rating scale, 0 represented no pain, 1-3 indicated mild pain, 4-6 indicated moderate pain, while 7-10 indicated severe pain.
Assessment of pressure pain threshold (PPT)
Time frame: 12 weeks
The PPT was measured for each participant in both groups (A \& B) before and after 12 weeks of treatment at the first day of menstruation, using a pressure algometry.
Assessment of health related quality of life
Time frame: 12 weeks
The health related quality of life of all participants in both groups (A \& B) was evaluated before and after the end of treatment program, using the Arabic version of EQ-5D-3L questionnaire.
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 13 Nov 2023.
- Derived from this study: PubMed 38767193Abdelrahman AY, El-Kosery SM, Abbassy AH, Botla AM. Effect of aquatic exercise versus aerobic exercise on primary dysmenorrhea and quality of life in adolescent females: A randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2095. doi: 10.1002/pri.2095.
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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.
Sohier M. Elkosery, Prof. study chair
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercise and Aerobic Exercise in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Egypt.
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 5 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 13 Nov 2023. 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 Egypt. 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?
Assessment of dysmenorrhea severity (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 NCT06129708, which also lists 1 linked publication.
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 13 Nov 2023.