Breathing Exercises on Depression in Postmenopausal Women

NCT ID: NCT06741384

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2025-03-25

Brief Summary

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Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women

Detailed Description

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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:

1. Depression (Beck Depression Inventory II scale).
2. Sexual function (female sexual function index questionnaire).

Conditions

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Postmenopausal Depressive Symptom Breathing Exercises

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Diaphragmatic breathing exercises group

30 women participating in diaphragmatic breathing plus aerobic training.

Group Type ACTIVE_COMPARATOR

Diaphragmatic breathing exercises

Intervention Type OTHER

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 training

Intervention Type OTHER

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.

Control group

30 women participating in aerobic training only.

Group Type ACTIVE_COMPARATOR

Aerobic training

Intervention Type OTHER

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.

Interventions

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Diaphragmatic breathing exercises

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.

Intervention Type OTHER

Aerobic training

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Prolapse of the pelvic organs.
* Pelvic tumors.
* Vaginal infections.
* Musculoskeletal/ neurological limitations to exercise.
* Psychiatric disorders.
* Unstable cardiovascular conditions.
* Diabetes.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Middle East University

OTHER

Sponsor Role lead

Responsible Party

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Saher Lotfy El Gayar

Assistant Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Sayed Saif, Ph.D

Role: STUDY_DIRECTOR

National institute for Gerontology

Central Contacts

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Saher Elgayar, Ph.D

Role: CONTACT

Phone: 01020429911

Email: [email protected]

Mohammed Elhamrawy, Ph.D

Role: CONTACT

Other Identifiers

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Breathing Exercises

Identifier Type: -

Identifier Source: org_study_id