Premenstrual SyndromeNCT03264612
Effect of Swimming on Premenstrual Syndrome
A study testing Aerobic exercise in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2016to 12 Aug 2017
- 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
- virgins.
- Their age ranged from 18 to 25 years old
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They were clinically and medically stable during the study
- Have regular menstrual cycle of 23 to 35 days duration
Who cannot join
- cardiopulmonary or orthopaedic problems
- women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study
- any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
- Women with endocrine abnormality as thyroid, pituitary or ovarian disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
Read the detailed description
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down. Warming up phase involved 5 minutes of breathing, circulatory and stretching exercises. Breathing diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was performed at a convenient position with full relaxation, then she inspires deeply through the nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that was repeated 3-5 times.
Costal breathing exercise was done also at the woman favorable position then she inspires deeply through the nose, opens out her ribs then expires through the mouth with a sigh and slowly and that was repeated 3-5 times..
Circulatory foot and ankle exercises were done by instructing the woman to point her toes up and down, doing isometric calf muscle contractions and knee flexion and extension.
Stretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers, triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor fascia latae and quadriceps muscles were performed during warming up phase.
The second phase of treatment was swimming for 20 minutes starting with 5 minutes walking inside the pool around its edges, then forth and back swimming without reaching fatigue level for 15 minutes.
The last phase was cooling down phase which was the same exercises of the warming up phase for 5 minutes
- Conditions
- Premenstrual Syndrome
- Being tested
- Aerobic exercise
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Also called Swimming
Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
| Study group | Role | What they receive |
|---|---|---|
| Swimming group | Active comparator | Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down. Receives: Behavioral: Aerobic exercise |
| Non swimming group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual distress questionnaire
47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)
Measured: 3 months after start of swimming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start3 Apr 2016
- Primary completion14 May 2017
- Study completion12 Aug 2017
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 Premenstrual SyndromeStudies 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264612
- Sponsor's protocol ID
- 10
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.
PubMed 29350276
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT03264612
- Acronym / sponsor ID
- 10
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Apr 2016 (actual)
- Primary completion
- 14 May 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 29 Aug 2017 (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.
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
Detailed description
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down. Warming up phase involved 5 minutes of breathing, circulatory and stretching exercises. Breathing diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was performed at a convenient position with full relaxation, then she inspires deeply through the nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that was repeated 3-5 times.
Costal breathing exercise was done also at the woman favorable position then she inspires deeply through the nose, opens out her ribs then expires through the mouth with a sigh and slowly and that was repeated 3-5 times..
Circulatory foot and ankle exercises were done by instructing the woman to point her toes up and down, doing isometric calf muscle contractions and knee flexion and extension.
Stretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers, triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor fascia latae and quadriceps muscles were performed during warming up phase.
The second phase of treatment was swimming for 20 minutes starting with 5 minutes walking inside the pool around its edges, then forth and back swimming without reaching fatigue level for 15 minutes.
The last phase was cooling down phase which was the same exercises of the warming up phase for 5 minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swimming group | Active comparator | Behavioral: Aerobic exerciseFemales in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down. |
| Non swimming group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- virgins.
- Their age ranged from 18 to 25 years old
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They were clinically and medically stable during the study
- Have regular menstrual cycle of 23 to 35 days duration
Key exclusion criteria (4 listed)
- cardiopulmonary or orthopaedic problems
- women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study
- any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
- Women with endocrine abnormality as thyroid, pituitary or ovarian disorders
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 |
|---|---|---|
| Aerobic exerciseAlso: SwimmingFemales in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down. | Behavioural | Swimming group |
Primary outcome
Premenstrual distress questionnaire
Time frame: 3 months after start of swimming
47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)
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 29 Aug 2017.
- Derived from this study: PubMed 29350276Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged, MD principal investigator
kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Premenstrual Syndrome, 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 5 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 29 Aug 2017. 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?
Premenstrual distress questionnaire (time frame: 3 months after start of swimming). 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 NCT03264612, 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 29 Aug 2017.