Protocol summary

Study aim
Determining the rate of changes in respiratory parameters and disease course in patients with moderate to severe Covid-19 infection by changing body position from supine to prone and pulmonary rehabilitation.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized on 105 patients. Randomized with random allocation software
Settings and conduct
In the two intervention groups, in addition to standard treatment measures, patients will be in a supine position for a maximum of two hours daily for one week and will undergo pulmonary rehabilitation for 15 minutes by a trained nursing expert. It will be recorded minutes after being in the prone position and also 60 minutes after the patient is in the supine position.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Covid-19 positive patients admitted to non-specialized wards, from 18 to 75 years old, non-intubated, under treatment, oxygen support, no bed sores on shoulder, knee and face, estimated weight less than 100 kg. Exclusion criteria: Patients with increased cerebral pressure, patients with increased intraocular pressure, dissatisfaction to participation.
Intervention groups
The three different groups studied are: The first group is patients who will receive only standard treatments of the national protocol for the treatment of Covid 19. (Control group) The second group, who will be receiving oxygen with a simple mask, will undergo peroneal and lung rehabilitation in addition to the national protocol treatments. The third group, who will be receiving oxygen with a reservoir mask, will undergo peroneal and lung rehabilitation in addition to the national protocol treatments.
Main outcome variables
spo2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210316050722N1
Registration date: 2021-05-30, 1400/03/09
Registration timing: registered_while_recruiting

Last update: 2021-05-30, 1400/03/09
Update count: 0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
meysam elhami jadid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3226 4830
Email address
st-elhami.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pulmonary rehabilitation and prone position on respiratory parameters in patients with COVID-19 admitted to non- specialized ward of Hajar hospital of Shahrekord; a double blind randomized clinical trial
Public title
Evaluation of the effects of lung rehabilitation and prone condition on respiratory parameters in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-positive patients admitted to non-specialized wards From 18 to 75 years old Non-intubated and supported by oxygen therapy, No bed sores on shoulders, knees, and face, Estimated weight less than 100 kg
Exclusion criteria:
Patients with increased cerebral pressure Patients with increased intraocular pressure, Dissatisfaction with participation in the study,
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants to study groups (control group and two intervention groups one and two) will be done using random allocation software. Then, envelopes are prepared according to the number of people participating in the study and are recorded on the first envelope number one, the second envelope number 2, etc. Becomes. In this way, with the entry of each person, a special envelope is opened for that person and according to the option inside the envelope, the person is assigned to one of the control groups, intervention one or intervention two.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the table, people will be included in study one by one and a special code will be assigned to each group and members of each group so that patients keep blind about the type of intervention (one blind) and on the other side is blindness by a statistical specialist who will analyze the data without knowing the study groups (blindness on the other side).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.SKUMS.REC.1399.277

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
spo2
Timepoint
30 and 60 minutes after being in the prone position and also 60 minutes after the patient is in the supine position.
Method of measurement
Standard pulse oximetry device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The second group of standard treatment measures of the state oxygen protocol with a normal mask + 2 hours of prone position + 15 minutes of lung rehabilitation
Category
Rehabilitation

2

Description
Intervention group: Group 3 standard treatment measures of the state oxygen protocol with reservoir mask + 2 hours of prone position + 15 minutes of lung rehabilitation
Category
Rehabilitation

3

Description
Control group: Group 1 will only receive the standard treatments recommended in the national protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Akbar Soleimani
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-elhami.m@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-elhami.m@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Meysam Elhami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-elhami.m@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Meysam Elhami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-elhami.m@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Meysam Elhami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-elhami.m@skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2021-2022
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
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