NCT05267067

Brief Summary

Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

February 13, 2022

Last Update Submit

February 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

    By respiratory pressure meter

    3 month

Study Arms (2)

manual respirtory exercises

ACTIVE COMPARATOR

Using manual traditional respiratory exercises.

Other: respiratory exercises

Respiratory exercises with respiratory pressure meter

ACTIVE COMPARATOR

Using pressure respiratory meter in exercises.

Other: respiratory exercises

Interventions

Manual respiratory exercises versus respiratory exercises with pressure meter

Respiratory exercises with respiratory pressure metermanual respirtory exercises

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male patients
  • underwent valve surgery (repair or replacement) for mitral valve stenosis;
  • hemodynamically stable,
  • ages ranged from 12 to 18 years old-
  • BMI ranges from 18.5 to 24.9
  • reduced MEP, MVV and complaining from shortness of breath with exertion.

You may not qualify if:

  • Patients with previous cardiac surgery
  • congenital heart disease
  • neurological disorders
  • type1 diabetes mellitus
  • smoker
  • pacemaker implantation
  • atrial fibrillation
  • utilization of mechanical ventilation longer than 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahar Abdalbary

Cairo, Select State/province, 11431, Egypt

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Abdallaha Mohamed, MD

    Nahda University, Faculty of Physical Therapy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 13, 2022

First Posted

March 4, 2022

Study Start

September 2, 2020

Primary Completion

January 20, 2021

Study Completion

February 1, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations