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

Primary Purpose

Corona Virus Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diaphragmatic positioning
incentive spirometer
Control
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring Diaphragmatic function, Post Covid, Exercises

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beni-Suef University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

diaphragmatic positioning group

incentive spirometer group

Arm Description

received, traditional medical treatment and no exercise

received diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak

received diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak

Outcomes

Primary Outcome Measures

Diaphragmatic thickness
Measured by ultrasonography
Pulmonary Function Test
MVV

Secondary Outcome Measures

Full Information

First Posted
February 25, 2023
Last Updated
March 23, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05787275
Brief Title
Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.
Official Title
Effect of Different Types of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid Syndrome. A Randomized Control Trail
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
Keywords
Diaphragmatic function, Post Covid, Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
received, traditional medical treatment and no exercise
Arm Title
diaphragmatic positioning group
Arm Type
Experimental
Arm Description
received diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak
Arm Title
incentive spirometer group
Arm Type
Experimental
Arm Description
received diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak
Intervention Type
Other
Intervention Name(s)
diaphragmatic positioning
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
incentive spirometer
Intervention Description
Traditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Traditional medical treatment
Primary Outcome Measure Information:
Title
Diaphragmatic thickness
Description
Measured by ultrasonography
Time Frame
6 weeks
Title
Pulmonary Function Test
Description
MVV
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Abo Elyazed
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University
City
Banī Suwayf
State/Province
Sharq
ZIP/Postal Code
11222
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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