Breathing Exercises on Depression in Po… | Clinical Trial

Key information

Conditions

Postmenopausal Behavior Behavioral Symptoms Breathing Exercises Depression Depressive Symptom

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaphragmatic breathing exercises

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

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.

Primary outcomes

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.

Secondary outcomes

Sexual function

Time frame: At baseline and after 8 weeks

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Elhamrawy, Ph.D

CONTACT

Saher Elgayar, Ph.D

CONTACT

[email protected]

01020429911

Sponsors and collaborators

Lead sponsor

Middle East University

Other

Registry information

Official study title

Effect of Breathing Exercises on Depression and Sexual Function in Postmenopausal Women

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 19, 2024
Registry last updated: Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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