NCT04919031

Brief Summary

Inspiratory muscle training considered as safe and valid method to improve respiratory muscle strength and functional capacity among uncountable conditions which could improve post COVID-19 persistent symptoms including but not limited to respiratory muscle strength, diminishing dyspnea, enhance blood oxygenation, and patient's functional capacity and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable covid19

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

June 7, 2021

Last Update Submit

February 6, 2023

Conditions

Covid19HypertensionCorona Persistent Symptoms

Outcome Measures

Primary Outcomes (1)

  • maximal inspiratory pressure

    For determining MIP, patients breathe through a flanged mouthpiece with nose clips in place. They are instructed to exhale to RV. At RV, a valve or shutter is closed, and the patient is coached to inhale as forcefully as possible. Maximum pull should be maintained for 1-2 seconds.

    6 weeks

Secondary Outcomes (11)

  • sleeping quality scale

    6 weeks

  • Timed stair climbing

    6 weeks

  • 6 minute walk test

    6 weeks

  • modified medical research council (mMRC) scale (0-4)

    6 weeks

  • Oxygen saturation

    6 weeks

  • +6 more secondary outcomes

Study Arms (2)

study

EXPERIMENTAL

Inspiratory muscle trainer plus diaphragmatic release and traditional medications

Device: Inspiratory muscle trainerOther: diaphragmatic release

control

ACTIVE COMPARATOR

inspiratory muscle trainer plus traditional medications

Device: Inspiratory muscle trainer

Interventions

Inspiratory muscle trainerDEVICE

POWER breathe IMT is a drug-free, hand-held breathing training device. The medical term for this type of breathing training is Inspiratory Muscle Training, or IMT. POWER breathe IMT exercises the main muscles you use to breathe in, primarily your diaphragm and intercostal

controlstudy
diaphragmatic releaseOTHER

diaphragmatic release is a manual technique use for restoring the ability of the diaphragm to go through a full range of motion

study

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sixty non hospitalized negative post covid-19
  • men
  • cigarette smokers
  • years old
  • stage II Hypertensive (160-179 / 100-109 mmHg)
  • Oxygen saturation less than 94%
  • Severity of disease (Moderate Covid-19 affection)
  • Body mass index (BMI) ranged from 25 to 29.9 kg/m2
  • hemodynamically stable
  • at least 4 weeks since first COVID-19 swab at time of screening

You may not qualify if:

  • Patients with red flag indicators as chest pain, critical drop of oxygen saturation which require oxygen supply, severe level of hypoxia (blue lips)
  • Unconscious patient
  • Positive covid-19 patients
  • Patients with cognitive impairment
  • End-stage of chronic diseases
  • BMI more than 30 kg/m2
  • History of other cardiovascular disease as coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
  • Neurological, neuromuscular, and musculoskeletal limitations
  • Current active infection
  • Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
  • Participation in a clinical study or other type of research in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

COVID-19Hypertension

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ebtesam N Nagy, doctoral

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 9, 2021

Study Start

August 1, 2021

Primary Completion

November 23, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
one year after study actual completion date

Locations

EG(1)