Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries

NCT ID: NCT06621693

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2025-01-30

Brief Summary

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This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery

Detailed Description

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Phrenic nerve injury post cardiac surgery is a serious problem closely related to frequent respiratory complications. It has been associated with diaphragm dysfunction, pneumonia and difficulty weaning from mechanical ventilation in critical ill patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy.

There is increased flow of patients after heart surgery in kasr Aini hospital who suffers from respiratory complication due to phrenic nerve injury so the hospitalization period of them increased which make economic burden in health insurance services with decreased level of quality of life that is the most concern as to improve patient status and relief this burden. So this study aims to decrease respiratory complication and improve phrenic nerve regeneration by using neuromuscular electrical stimulation as a safe, noninvasive , inexpensive and virtually risk free method.

Conditions

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Post-cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group

This group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks

Group Type EXPERIMENTAL

Transcutaneous electrical diaphragmatic stimulation intervention

Intervention Type DEVICE

It will be applied on diaphragm, 30 min per session ,3 days/week for 4 weeks at a stimulation frequency of 30 Hz, pulse width of 400 μs, the intensity was gradually increased until visible muscle contraction was observed.

traditional physiotherapy program

Intervention Type OTHER

The participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks

Traditional physiotherapy group

This group will receive traditional physiotherapy only, three times per week for 4 weeks

Group Type ACTIVE_COMPARATOR

traditional physiotherapy program

Intervention Type OTHER

The participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks

Interventions

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Transcutaneous electrical diaphragmatic stimulation intervention

It will be applied on diaphragm, 30 min per session ,3 days/week for 4 weeks at a stimulation frequency of 30 Hz, pulse width of 400 μs, the intensity was gradually increased until visible muscle contraction was observed.

Intervention Type DEVICE

traditional physiotherapy program

The participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients post cardiac surgery (coronary artery bypass graft, valve repair or replacement ).
* Patients referred by physician.
* Medically stable patients.
* Both genders
* Ages from 25 to 45
* BMI 25-29.9 kg/m2
* Able to understand the requirements of the study.
* Conscious patient and respond to verbal commands.

Exclusion Criteria

Participants will be excluded if they meet one of the following criteria:

* Patients with rib fracture.
* Patients developing lung cancer.
* Patients have dementia.
* Patients on mechanical ventilator after 24 hours
* Metabolically unstable chronic illness
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hala Atef Abd El Fatah

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala R. Mahmoud, professor

Role: STUDY_DIRECTOR

Cairo University

Nagwa M. Badr, professor

Role: STUDY_CHAIR

Cairo University

Locations

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Hala Atef Abdel Fattah

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hala A. Abdel Fattah, Master

Role: CONTACT

+201027551192

Rana H. El Banaa, PHD

Role: CONTACT

+201062070686

Other Identifiers

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P.T.REC/012/005299

Identifier Type: -

Identifier Source: org_study_id

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