- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787275
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
-
-
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
|
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
|
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
|
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
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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