Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery
Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 13, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedMarch 4, 2022
February 1, 2022
5 months
February 13, 2022
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 COMPARATORUsing manual traditional respiratory exercises.
Respiratory exercises with respiratory pressure meter
ACTIVE COMPARATORUsing pressure respiratory meter in exercises.
Interventions
Manual respiratory exercises versus respiratory exercises with pressure meter
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Sahar Abdalbary
Cairo, Select State/province, 11431, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Abdallaha Mohamed, MD
Nahda University, Faculty of Physical Therapy
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