Evaluation of the effectiveness of pulmonary rehabilitation in the rehabilitation center in comparison with tele rehabilitation on the prognosis of patients with Covid-19
Comparison of the average activities of daily living, the average quality of life, the findings of the 6MWT and Barthel Index before and after the intervention in the intervention and control groups.
Design
Clinical trial with control group, with parallel groups, randomized, on 52 patients. Data analysis is done using SPSS version 25 software.
Settings and conduct
A questionnaire including demographic information, quality of life, stress and depression and Barthel index is given to each patient. Then the patients are placed in one of the two groups of pulmonary rehabilitation in the rehabilitation center or tele rehabilitation. Patients in the first group are treated with a course of respiratory physiotherapy by visiting the rehabilitation center, and patients in the second group are treated with a respiratory physiotherapy program that is given to them in the form of a brochure. Patients are evaluated before the beginning of pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. No blinding done.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. Patients with a definite diagnosis of covid19
2. Age > 30 and < 60 years
Exclusion criteria :
underlying lung disease, neuromuscular diseases, heart disease
Intervention groups
The intervention group includes patients with covid-19 who receive respiratory rehabilitation intervention in the rehabilitation center.
The comparison group includes patients with covid-19 who receive remote respiratory rehabilitation intervention.
Main outcome variables
Quality of life questionnaire score; Activities of daily living questionnaire score; Hospital anxiety and depression scale score; Bartel index score; The amount of distance traveled in the 6-minute walking test based on meters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220723055525N1
Registration date:2022-09-07, 1401/06/16
Registration timing:registered_while_recruiting
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
soheila shahbaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8870 7584
Email address
so.sh82@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-29, 1401/05/07
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of pulmonary rehabilitation in the rehabilitation center in comparison with tele rehabilitation on the prognosis of patients with Covid-19
Public title
Evaluation of the effectiveness of pulmonary rehabilitation on the prognosis of patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with difinit diagnosis of COVID-19 according to PCR
Age between 30 to 60 years
Having symptoms of cough and dyspnea
Moderate to severe pulmonary involvement according to CT scan ( less than 50% pulmonary involvement according to CT scan)
3 weeks after positive PCR test
No COPD disease
No cardiac disease
Exclusion criteria:
COPD, asthma and any underlying lung disease
Neuromuscular diseases that affect lung function
History of ischemic heart disease, congestive heart failure and uncontrolled blood pressure
Asymptomatic carriers
Severe comorbidity
Unwillingness to participate in the study
Lack of access to the Internet and virtual programs
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization tool is version 2 of the Random Allocation software.
Using the software, the order of the random chain is determined, and then the patients of the intervention and control groups are entered into the chain based on the order obtained through the software.
For example, first blocks of 8 are prepared, each block of 8 includes 4 patients for the control group and 4 patients for the intervention group. In one block, the first four patients may be placed in the control group and the next four patients in the intervention group, and in another block, the patients may be divided one by one.
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 Artesh University of Medical Sciences
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Quality of life questionnaire
2
Description
activities of daily living
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Daily activity questionnaire
3
Description
psychological status in terms of anxiety and depression
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Hospital anxiety and depression scale
4
Description
Barthel index
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Barthel questionnaire
5
Description
6 minute walking test
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
6 minute walking test results
Secondary outcomes
1
Description
Pulse rate
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Pulse oximeter device
2
Description
Oxygen saturation percentage
Timepoint
Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation
Method of measurement
Pulse oximeter device
Intervention groups
1
Description
Intervention group: Patients in the first group are treated with a course of respiratory muscle physiotherapy by visiting the rehabilitation center. These measures are performed on the day of the patient's visit and then repeated 1 month and 3 months later in 15-minute sessions. In this treatment method, strengthening of respiratory muscles is taught by performing movements. Equipment or medicine is not used during these sessions.
Category
Rehabilitation
2
Description
Control group: The patients of the second group are treated with a 15-minute respiratory physiotherapy program, which is taught how to do it by a brochure, and they are followed up on the day of referral, and then 1 month later and 3 months later in terms of home training. In this treatment method, strengthening of respiratory muscles is taught by performing movements. No equipment or medicine is used in this method.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine in Artesh Medical Sciences Hospital