To identify the effect of virtual pulmonary rehabilitation on the outcome and quality of life of COVID19 patients after recovery from the acute phase
Design
Clinical trial with control group, with parallel groups, randomized on 70 patients, for randomization, permutation blocks with 4 samples in each block using Random Allocation software was used.
Settings and conduct
Breathing exercises in the form of educational videos will be provided to the intervention group in a virtual way using the training site, and patients should do the exercises for 8 weeks 5 days a week, three times a day and three repetitions each time.
Participants/Inclusion and exclusion criteria
Definite diagnosis of covid 19 with PCR
Hospitalization during the acute phase of the disease
Lung involvement with a typical pattern of covid 19 in chest X ray or chest CT scan
Being clinically stable
Being able to understand and perform the virtual respiratory exercises as given to them in the study
Age over 18 and less than 60 years
Intervention groups
Virtual pulmonary rehabilitation in the form of breathing exercise for intervention group
Main outcome variables
The perceived dyspnea severity during daily activities, The severity of dyspnea, General health-related quality of life, Psychological state and mood disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200930048892N1
Registration date:2020-10-18, 1399/07/27
Registration timing:prospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Fariba Erfani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5383 8166
Email address
erfanif70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-20, 1399/07/29
Expected recruitment end date
2021-02-17, 1399/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of virtual pulmonary rehabilitation on the outcome and quality of life of COVID 19 patients after recovery from the acute phase
Public title
evaluation the effect of virtual pulmonary rehabilitaion on covid 19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of covid 19 with PCR
Hospitalization during the acute phase of the disease
Lung involvement with a typical pattern of covid 19 in chest X ray or chest CT scan
Being clinically stable
Being able to understand and perform the virtual respiratory exercises as given to them in the study
Age > 18 and < 60 years
Exclusion criteria:
COPD, asthma and any other respiratory disease
Neuromuscular disorders that affect lung function
History of ischemic heart disease, congestive heart failure and uncontrolled hypertension
Asymptomatic carriers
Sever comorbid conditions
Disagree to participate in the study
Lack of access to the internet and virtual applications
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method was performed based on random permutation blocks with 4 samples in each block and a random list of data was obtained using Random Allocation software. Independent T test and paired T test will be used for statistical analysis of the data. Blindness will be done for people who measure the outcomes and people who analyze the data
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Medical School. Imam Hossein Square.Zand Stree .Shiraz Cityt
City
shiraz
Province
Fars
Postal code
7134845794
Approval date
2020-10-02, 1399/07/11
Ethics committee reference number
IR.SUMS.MED.REC.1399.364
Health conditions studied
1
Description of health condition studied
COVID 19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The perceived dyspnea severity during daily activities
Timepoint
Before intervention and 8 weeks after study
Method of measurement
Medical Research Council Scale
2
Description
The severity of dyspnea
Timepoint
Before intervention and 8 weeks after study
Method of measurement
Modified Borg Scale
3
Description
General health-related quality of life
Timepoint
Before intervention and 8 weeks after study
Method of measurement
Short-Form 36 (SF-36)
4
Description
psychological state and mood disorder
Timepoint
Before intervention and 8 weeks after study
Method of measurement
The Hospital Anxiety and Depression Scale (HADS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: virtual pulmonary rehabilitation in the form of breathing exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Seyed Mohammad Kazem Tadayyon
Street address
Zand Blvd, Shiraz City
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Ali Asghar hospital
Full name of responsible person
Parnian Nikmanesh
Street address
Meshkin fam street
City
Shiraz
Province
Fars
Postal code
7143918796
Phone
+98 71 3228 8907
Email
aliasghar@sums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Seyed Rouhollah Mousavi
Street address
Chamran Blvd, Shiraz City
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
chamhosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeian zade
Street address
Zand Blvd. Shiraz Univercity of Science,Shiraz City
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Erfani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16, Nasr Blvd,Taleghani Street , Neyriz
City
Neyriz
Province
Fars
Postal code
7491944388
Phone
+98 71 5383 8166
Email
erfanif70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Erfani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16, Nasr Blvd. Taleghani Street, Neyriz
City
Neyriz
Province
Fars
Postal code
7491944388
Phone
+98 71 5383 8166
Email
erfanif70@gmail .com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Erfani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16, Nasr Blvd,Taleghani Street , Neyriz
City
Neyriz
Province
Fars
Postal code
7491944388
Phone
+98 71 5383 8166
Email
erfanif70@gmail.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