NCT06621693

Brief Summary

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

Trial Health

43
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 Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 29, 2024

Last Update Submit

September 29, 2024

Conditions

Post-cardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • Phrenic nerve conduction study: motor latency

    Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study. Motor latency is the impulse traveled from the stimulation site to the recording site is called latency and it is measured in milliseconds (ms). its normal value: (5.74ms -7.10 ms).

    4 weeks

  • Phrenic nerve conduction study: Amplitude

    Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study. Amplitude represents the maximal action potential depolarization and voltage gradient for all depolarized fibers of the phrenic nerve. it is measured in microvolt or millivolt (mv). its normal value: (0.47 mv-0.83 mv).

    4 weeks

Study Arms (2)

Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group

EXPERIMENTAL

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

Device: Transcutaneous electrical diaphragmatic stimulation interventionOther: traditional physiotherapy program

Traditional physiotherapy group

ACTIVE COMPARATOR

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

Other: traditional physiotherapy program

Interventions

Transcutaneous electrical diaphragmatic stimulation interventionDEVICE

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.

Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group
traditional physiotherapy programOTHER

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 groupTranscutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hala Atef Abdel Fattah

Cairo, Egypt

Location

Study Officials

  • Hala R. Mahmoud, professor

    Cairo University

    STUDY DIRECTOR

  • Nagwa M. Badr, professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hala A. Abdel Fattah, Master

CONTACT

+201027551192hala.atef1996@gmail.com

Rana H. El Banaa, PHD

CONTACT

+201062070686rana.elbanna@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 1, 2024

Study Start

October 4, 2024

Primary Completion

January 15, 2025

Study Completion

January 30, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)