Breathing Exercises on Depression in Postmenopausal Women

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postmenopausal; Breathing Exercises; Depressive Symptom
• Intervention / Treatment: Other: Diaphragmatic breathing exercises; Other: Aerobic training

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Elgayar, Ph.D; Phone Number: 01020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Elhamrawy, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diaphragmatic breathing exercises group; 30 women participating in diaphragmatic breathing plus aerobic training.	Other: 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.; 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.
Active Comparator: Control group; 30 women participating in aerobic training only.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Middle East University
• Investigators: Study Director: Mohammed Sayed Saif, Ph.D, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2024
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): March 25, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Behavioral Symptoms; Respiratory Tract Diseases; Respiration Disorders; Depression; Respiratory Aspiration
• Other Study ID Numbers: Breathing Exercises

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No