NCT06741384

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

December 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 17, 2024

Last Update Submit

December 18, 2024

Conditions

PostmenopausalDepressive SymptomBreathing Exercises

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sexual function

    At baseline and after 8 weeks

Study Arms (2)

Diaphragmatic breathing exercises group

ACTIVE COMPARATOR

30 women participating in diaphragmatic breathing plus aerobic training.

Other: Diaphragmatic breathing exercisesOther: Aerobic training

Control group

ACTIVE COMPARATOR

30 women participating in aerobic training only.

Other: Aerobic training

Interventions

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.

Diaphragmatic breathing exercises group
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.

Control groupDiaphragmatic breathing exercises group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Mohammed Sayed Saif, Ph.D

    National institute for Gerontology

    STUDY DIRECTOR

Central Study Contacts

Saher Elgayar, Ph.D

CONTACT

01020429911saherlotfy020@gmail.com

Mohammed Elhamrawy, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 19, 2024

Study Start

December 26, 2024

Primary Completion

March 20, 2025

Study Completion

March 25, 2025

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share