Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.

March 23, 2023 updated by: Tamer Ibrahim Abo Elyazed, Beni-Suef University

Effect of Different Types of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid Syndrome. A Randomized Control Trail

The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharq
      • Banī Suwayf, Sharq, Egypt, 11222
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female above 18 years old
  • history of probable or confirmed SARS-CoV-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms .

Exclusion Criteria:

  • Subjects under 18.
  • Patients known to have chronic lung disease .
  • Patients known to have neuromuscular disorder.
  • Patients known to have diaphragmatic hernia.
  • Patients known to have malignancy.
  • Patients with clinical evidence of phrenic nerve injury.
  • Patients with recent abdominal or thoracic surgery,
  • Patients with history of traumatic lesion possibly affecting diaphragm.
  • Subjects with severe malnutrition.
  • Patients with BMI more than 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
received, traditional medical treatment and no exercise
Other: Control
Traditional medical treatment
Experimental: diaphragmatic positioning group
received diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak
Other: diaphragmatic positioning
Traditional medical treatment plus diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak
Experimental: incentive spirometer group
received diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak
Other: incentive spirometer
Traditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic thickness
Time Frame: 6 weeks
Measured by ultrasonography
6 weeks
Pulmonary Function Test
Time Frame: 6 weeks
MVV
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Tamer Abo Elyazed, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

February 2, 2023

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuefU3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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