NCT05787275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 25, 2023

Last Update Submit

March 23, 2023

Conditions

Corona Virus Infection

Keywords

Diaphragmatic functionPost CovidExercises

Outcome Measures

Primary Outcomes (2)

  • Diaphragmatic thickness

    Measured by ultrasonography

    6 weeks

  • Pulmonary Function Test

    MVV

    6 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

received, traditional medical treatment and no exercise

Other: Control

diaphragmatic positioning group

EXPERIMENTAL

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

incentive spirometer group

EXPERIMENTAL

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

Other: incentive spirometer

Interventions

diaphragmatic positioningOTHER

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

diaphragmatic positioning group
incentive spirometerOTHER

Traditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak

incentive spirometer group
ControlOTHER

Traditional medical treatment

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Banī Suwayf, Sharq, 11222, Egypt

Location

MeSH Terms

Conditions

Coronavirus InfectionsMotor Activity

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBehavior

Study Officials

  • Tamer Abo Elyazed

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 28, 2023

Study Start

October 1, 2022

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)