Protocol summary

Study aim
Evaluation of the effect of respiratory physiotherapy on pulmonary function including respiratory capacity, the tidal volume, residual volume, number of breaths, and its frequency while walking on a treadmill, O2-CO2 gas concentration in inhalation and exhalation, parameters related to spirometry In patients with COVID-19 in its recovery period.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 44 patients. The random table of numbers is used for randomization.
Settings and conduct
In the next stage, after assigning patients to intervention and control groups, patients in the intervention group are asked to go to the physiotherapy clinic for 10 days a week for 10 sessions and under the supervision of a physiotherapist with at least 10 years experience in respiratory physiotherapy, interventions To receive. The control group receives its routine treatments prescribed by the relevant physician.
Participants/Inclusion and exclusion criteria
Patients aged 35-55 years old who have a history of hospitalization due to COVID-19 virus. A minimum of 1 month and a maximum of 2 months have elapsed since discharge from the hospital and a positive PCR test or diagnosis of lung involvement based on CT scan of the lung at the time of hospitalization.
Intervention groups
Chest physiotherapy intervention: 1- Segmental breathing exercises for lung lobes in lying and sitting position 2- Proper posture (postural drainage) 3- Deep breathing and diaphragmatic exercises 4- Incentive spirometer 5- Controlled movement and movement and breathing exercises while riding a stationary bike In the control group, after the study phase, 10 sessions of physiotherapy will be performed as mentioned.
Main outcome variables
Tidal volume, Residual volume, FEV1, FEV time,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160808029264N9
Registration date: 2020-08-15, 1399/05/25
Registration timing: prospective

Last update: 2020-08-15, 1399/05/25
Update count: 0
Registration date
2020-08-15, 1399/05/25
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of chest physiotherapy on respiratory capacity and the rate of respiratory gas exchange during walking on the treadmill in patients with COVID-19 after the recovery stage
Public title
Effects of chest physiotherapy in COVID-19 patients with respiratory infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with a history of hospitalization in the Hospital of Semnan University of Medical Sciences due to the COVID-19 virus. A minimum of 1 month and a maximum of 2 months from the time of discharge from the hospital Positive PCR test or diagnosis of lung involvement based on CT scan of the lung at the time of admission No drug and smoking addiction No previous history of chronic lung disease Lack of musculoskeletal diseases such as tumor fractures and ...
Exclusion criteria:
Any aggravation of the patient's symptoms due to shortness of breath and pain in the chest and dizziness, abnormal sweating, blurred vision and nausea ... Any cases that are prohibited for performing chest physiotherapy intervention in people with this disease.
Age
From 35 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method in the form of a random number table will be used. Patients with odd numbers will be assigned in the intervention group and patients with even numbers will be assigned in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind randomized clinical trial. In this way, patients are divided into two groups by one researcher who does not interfere in the intervention and evaluation of results, and in addition, the evaluation will be performed by another researcher who is not aware of grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Mashahir Sq., Ghods Ave., Neuromuscular Rehabilitation Research Center.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.SEMUMS.REC.1399.111

Health conditions studied

1

Description of health condition studied
Respiratory infection due to COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Tidal volume, residual volume and other lung volumes while resting and running on a treadmill
Timepoint
Before and after the physiotherapy intervention
Method of measurement
Spirometry device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Chest physiotherapy intervention 5 days in a week for 10 sessions: 1- Segmental breathing exercises for lung lobes in lying and sitting position 2- Proper posture (postural drainage) 3- Deep breathing and diaphragmatic exercises 4- Incentive spirometer 5- Controlled movement and movement and breathing exercises while riding a stationary bike.
Category
Rehabilitation

2

Description
Control group: Standard treatments include medications prescribed for the disease as directed by the treating physician. In the control group, after the study phase, 10 sessions of physiotherapy will be performed as mentioned in the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Mohammad Memarian
Street address
Basij Ave., Kosar Hospital
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4180
Email
draria2014@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Basij Ave., Deputy of research and technology
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ghods Ave., Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4180
Email
rasool.bagheri@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ghods Ave., Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4180
Email
Rasool.bagheri@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ghods Ave., Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4180
Email
Rasool.bagheri@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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