PostmenopausalNCT06741384
Breathing Exercises on Depression in Postmenopausal Women
A study testing Diaphragmatic breathing exercises and Aerobic training in people with Postmenopausal and Depressive Symptom, run by Middle East University.
Trial summary
Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Postmenopausal, Depressive Symptom, Breathing Exercises
- What is being tested?
- Diaphragmatic breathing exercises and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2024to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Minimum of 3 years after menopause.
- Mild to moderate depression.
- Mild to moderate sexual dysfunction.
- Their ages will be ranged from 45 to 60 years old.
- Their BMI will be less than 30 kg/m2.
Who cannot join
- Prolapse of the pelvic organs.
- Pelvic tumors.
- Vaginal infections.
- Musculoskeletal/ neurological limitations to exercise.
- Psychiatric disorders.
- Unstable cardiovascular conditions.
- Diabetes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Elhamrawy, Ph.D contact
About this study
Official title: Effect of Breathing Exercises on Depression and Sexual Function in Postmenopausal Women
Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women
Read the detailed description
Sixty postmenopausal women will be sourced from the Obstetrics \& Gynecology outpatient clinic at El Mahalla El Kobra general hospital in Egypt, with referrals from gynecologists. Patients will be randomly assigned into two groups.
Study group: It will include 30 women participating in diaphragmatic breathing plus aerobic training.
Control group: It will include 30 women participating in aerobic training.
At baseline and poststudy, the following outcomes will be assessed:
- Depression (Beck Depression Inventory II scale).
- Sexual function (female sexual function index questionnaire).
- Conditions
- Postmenopausal, Depressive Symptom, Breathing Exercises
- Being tested
- Diaphragmatic breathing exercises, Aerobic training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exercisesOther
Participants will be directed to position their hands on the rectus abdominis muscle located under the anterior chest wall while resting in a hook position. They will be instructed to inhale slowly and deeply via the nostrils, expanding their abdomen without raising their upper chest, and resting their shoulders. Following the cessation of respiration, the woman will slowly exhale by pursing her lips. A respiratory cycle will consist of a three-second inhalation, a three-second pause, and a six-second exhalation. The diaphragmatic training regimen will consist of doing 3-5 sets of 5-10 deep breaths, with 2-minute intervals of rest in between sets.
Aerobic trainingOther
The women will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing exercises group | Active comparator | 30 women participating in diaphragmatic breathing plus aerobic training. Receives: Other: Diaphragmatic breathing exercises; Other: Aerobic training |
| Control group | Active comparator | 30 women participating in aerobic training only. Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The second edition of Beck depression inventory scale will be scored. The second edition of Beck depression inventory scale consists of 21- items. Item scores ranging from 0 to 3 are combined to produce a total score that ranges from 0 to 63 using the cumulative scoring technique. Elevated scores suggest a more severe level of depression.
Measured: At baseline and after 8 weeks
Secondary outcomes (1)
Sexual function
Female sexual function index questionnaire will be scored. The female sexual function index questionnaire is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function. The 19 items of the female sexual function index questionnaire use a 5-point scale ranging from 1 to 5 with higher scores indicating greater levels of sexual functioning on the respective item. Total scores of 26.5 or lower characterize sexual dysfunction.
Measured: At baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start26 Dec 2024 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Middle East University
- Investigators
- Mohammed Sayed Saif, Ph.D, Study director, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741384
- Sponsor's protocol ID
- Breathing Exercises
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercises on Depression and Sexual Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06741384
- Acronym / sponsor ID
- Breathing Exercises
- Conditions
- Postmenopausal, Depressive Symptom, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 26 Dec 2024 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 19 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.
Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women
Detailed description
Sixty postmenopausal women will be sourced from the Obstetrics \& Gynecology outpatient clinic at El Mahalla El Kobra general hospital in Egypt, with referrals from gynecologists. Patients will be randomly assigned into two groups.
Study group: It will include 30 women participating in diaphragmatic breathing plus aerobic training.
Control group: It will include 30 women participating in aerobic training.
At baseline and poststudy, the following outcomes will be assessed:
- Depression (Beck Depression Inventory II scale).
- Sexual function (female sexual function index questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing exercises group | Active comparator | Other: Diaphragmatic breathing exercises, Other: Aerobic training30 women participating in diaphragmatic breathing plus aerobic training. |
| Control group | Active comparator | Other: Aerobic training30 women participating in aerobic training only. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Minimum of 3 years after menopause.
- Mild to moderate depression.
- Mild to moderate sexual dysfunction.
- Their ages will be ranged from 45 to 60 years old.
- Their BMI will be less than 30 kg/m2.
Key exclusion criteria (7 listed)
- Prolapse of the pelvic organs.
- Pelvic tumors.
- Vaginal infections.
- Musculoskeletal/ neurological limitations to exercise.
- Psychiatric 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 |
|---|---|---|
| Diaphragmatic breathing exercisesParticipants will be directed to position their hands on the rectus abdominis muscle located under the anterior chest wall while resting in a hook position. They will be instructed to inhale slowly and deeply via the nostrils, expanding their abdomen without raising their upper chest, and resting their shoulders. Following the cessation of respiration, the woman will slowly exhale by pursing her lips. A respiratory cycle will consist of a three-second inhalation, a three-second pause, and a six-second exhalation. The diaphragmatic training regimen will consist of doing 3-5 sets of 5-10 deep breaths, with 2-minute intervals of rest in between sets. | Other | Diaphragmatic breathing exercises group |
| Aerobic trainingThe women will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down. | Other | Control group, Diaphragmatic breathing exercises group |
Primary outcome
Depression
Time frame: At baseline and after 8 weeks
The second edition of Beck depression inventory scale will be scored. The second edition of Beck depression inventory scale consists of 21- items. Item scores ranging from 0 to 3 are combined to produce a total score that ranges from 0 to 63 using the cumulative scoring technique. Elevated scores suggest a more severe level of depression.
1 secondary outcome
Sexual function
Time frame: At baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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.
Mohammed Elhamrawy, Ph.D contact
Mohammed Sayed Saif, Ph.D study director
National institute for Gerontology
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercises and Aerobic training in people with Postmenopausal and Depressive Symptom, run by Middle East University.
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 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: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Elgayar, Ph.D (01020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: At baseline and after 8 weeks). 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 20 Dec 2024.