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

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT05787275

Collaborator

(none)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

22.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection	Other: diaphragmatic positioning Other: incentive spirometer Other: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Actual Primary Completion Date :

Feb 2, 2023

Actual Study Completion Date :

Feb 2, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diaphragmatic thickness [6 weeks]
Measured by ultrasonography
Pulmonary Function Test [6 weeks]
MVV

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni-Suef University	Banī Suwayf	Sharq	Egypt	11222

Sponsors and Collaborators

Beni-Suef University

Investigators

Principal Investigator: Tamer Abo Elyazed, Beni-Suef University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Ibrahim Abo Elyazed, Associate Professor of Physical Therapy, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT05787275

Other Study ID Numbers:

BeniSuefU3

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tamer Ibrahim Abo Elyazed, Associate Professor of Physical Therapy, Beni-Suef University

Diaphragmatic function

Post Covid

Exercises

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Mar 28, 2023