This study aims to evaluate the efficacy of pulmonary telerehabilitation vs. rehabilitation in patients with Covid-19.
Design
This study is a single-blind, two-armed parallel randomized controlled trial in which participants would be blinded.
Settings and conduct
The pulmonary telerehabilitation program will perform through WhatsApp (video call) platform. This program includes 2 sessions of one hour per week of pulmonary exercises, such as diaphragmatic breathing exercises, and hand massages. The third week after the intervention, pulmonary outcomes will be assessed. Regarding the control group, the same program will be performed for patients with Covid-19 who are candidates for the rehabilitation program. Onsite rehabilitation programs will be held at the physical medicine and rehabilitation research center, Shohadaye Tajrish Hospital, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion:
1- Patients who were diagnosed with Covid-19 and discharged from the hospital. 2- Patients aged between 18 to 80 years.
Exclusion:
1- Patients who are unwilling to continue their participation in the study. 2- Having chronic diseases. 3- Patients who have participated in any rehabilitation programs during the study.
Intervention groups
Patients in the intervention group will receive a telerehabilitation program through 2 sessions per week. on the other hand, patients enrolled in the control group will receive the onsite rehabilitation program, as same as the intervention group.
Main outcome variables
O2 saturation, the 36-Item Short Form Survey (SF-36), Borg scale, and Heart rate before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220103053609N1
Registration date:2022-02-19, 1400/11/30
Registration timing:registered_while_recruiting
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Mahsa Ghorbanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2219 6207
Email address
mahsaghorbanzadeh1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Telerehabilitation on Pulmonary Functions in Discharged Patients with Covid-19; A Single-Blind Parallel-Randomized Controlled Trial
Public title
Efficacy of Pulmonary Telerehabilitation in Patients with Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients who were diagnosed with Covid-19 and discharged from the hospital. 2- Patients who are desired to participate in the study. 3- Patients aged between 18 to 80 years. 4- Having accessibility to the Internet.
Exclusion criteria:
1- Patients who are unwilling to continue their participation in the study. 2- Having chronic diseases, such as pulmonary disease, kidney diseases, neurologic disease, high blood pressure, uncontrolled heart disease, rheumatic diseases, cognitive disorders and psychological problems, and musculoskeletal disease. 3. Patients who have undergone any physiotherapy. 4. Patients who have participated in any rehabilitation programs during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 60 patients with a previous diagnosis of Covid-19 and discharged from the hospital randomely will be included in the study .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with siza of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order .In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blinded and blinding is done only on the analyzer without knowledge about two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
Intervention group: Pulmonary telerehabilitation will be done through communication via video call with the help of WhatsApp program. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of third week, which is the time of the final follow-up.
Category
Rehabilitation
2
Description
Control group:Pulmonary rehabilitation will be done in rehabilitation center of shohada Tajrish Hospital. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of third week, which is the time of the final follow-up.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih daneshvari hospital
Full name of responsible person
Mahsa ghorbanzadeh
Street address
Unit 5, No 10, eastern Nazaru alley, Sadaf St, Weastern Sarv St, Saadatabad
City
Tehran
Province
Tehran
Postal code
1998845739
Phone
+98 21 2219 4207
Email
Mahsaghorbanzadeh1992@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Unit 5, No 10, eastern nazari alley, Sadaf St, western sarv St, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998845739
Phone
+98 912 484 8648
Email
Mahsaghorbanzadeh1992@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa ghorbanzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 5, No 5, eastern Nazari alley, Sadaf St, western Sarv St, Saadatabad
City
Tehran
Province
Tehran
Postal code
1998845739
Phone
+98 21 2219 4207
Email
Mahsaghorbanzadeh1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa ghorbanzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 5, No 10, eastern Nazari alley, Sadaf St, western Sarv St, Saadatabad
City
Tehran
Province
Tehran
Postal code
1998845739
Phone
+98 21 2219 6207
Email
Mahsaghorbanzadeh1992@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa ghorbanzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 5, No 10, eastern nazari alley, Sadaf St, western sarv St, Saadat Abad
City
Tehran
Province
Tehran
Postal code
198845739
Phone
+98 21 2219 6207
Email
Mahsaghorbanzadeh1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient data can be shared through files after identifying them.
When the data will become available and for how long
Access period 1 month after printing the results
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
Any use to help advance science is unrestricted.
From where data/document is obtainable
Email address to mahsa ghorbanzadeh
Mahsaghorbanzadeh1992@gmail.com
What processes are involved for a request to access data/document
After sending an email to request, they can access the information within a month.