Protocol summary
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Study aim
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Improving general health in patients infected with Covid-19, by using virtual education of breathing exercises.
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Design
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Clinical trial with control group, with parallel group, double-blind, randomized, phase 3 on 70 patients. Blocked random method is used for randomization.
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Settings and conduct
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Patients in the treatment group learn respiratory exercises through virtual training and are regularly monitored during the 4 weeks of study; While the control group only receives sports training in the form of pamphlets and basic explanations. Patients in both groups complete the general health questionnaire before and after the study and the results are compared. Questionnaire questioner and statistical analyzer are blind in this study
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Participants/Inclusion and exclusion criteria
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The inclusion criteria: 1) being diagnosed with COVID through PCR test or typical pattern through X-ray or CT Scan 2) a mild form of this virus which enables patients to look after themselves at home and they do not need to be hospitalized 3)having clinical stability 4)being able to understand and do breathing exercises online 5)being in the 18 to 65 age groups.
The exclusion criteria : 1) having other lung diseases such as COPD and asthma 2) having advanced background heart diseases 3) having background uncontrolled diseases 4) being infected and hospitalized due to COVID 5) having background lower and upper motor neuron diseases 6) lack of awareness of and access to virtual world 7) refusing consent for participating in this study
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Intervention groups
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Patients in the treatment group learn breathing exercises through virtual training and are monitored regularly throughout the 4 weeks of study; While the control group only receives sports training in the form of pamphlets and basic explanations.
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Main outcome variables
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Improving public health and reduction of anxiety and depression in patients with Corona Virus
General information
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Reason for update
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Due to the late acceptance of the proposal, the start date of the work and the patient were postponed, and since this study is a clinical coincidence, the start and end date of the work is edited.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201204049600N1
Registration date:
2021-04-06, 1400/01/17
Registration timing:
prospective
Last update:
2021-04-27, 1400/02/07
Update count:
1
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Registration date
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2021-04-06, 1400/01/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-31, 1400/03/10
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Expected recruitment end date
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2021-09-11, 1400/06/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the impact of breathing exercise ( through virtual education )on the general health of patients infected with Covid-19 in shiraz . Randomized clinical trial
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Public title
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Investigating the impact of breathing exercises on general health of patient infected with Covid-19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being diagnosed with COVID-19 through PCR test.
Pulmonary involvement with typical pattern through Chest X-ray or Chest CT Scan.
A mild form of disease which enables patients to look after themselves at home and they do not need to be hospitalized.
Having clinical stability.
Being able to understand and do breathing exercises online.
Being in the 18 to 65 age groups.
Exclusion criteria:
Presence and history of other lung diseases such as COPD and asthma...
History of advanced heart disease such as IHD and CHF...
History of uncontrolled diseases including liver, kidney and thyroid and...
History of hospitalization in ICU due to Corona VIRUS.
History of lower motor neuron diseases including motor neuron diseases, peripheral neuropathy, neuromuscular junction disease and myopathy
History of upper motor neuron diseases such as stroke and M.S and... .
Lack of access and awareness of cyberspace.
Dissatisfaction with participating in the study.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this clinical intervention study, patients in both groups are the same and are randomly assigned; Thus, random allocation of patients is done using block randomization with two permutations AB and BA. In this way, 35 numbers are randomly selected from the table of random numbers, and if the numbers are between zero and 4, block AB is assigned to them, and if they are 5-9, block BA is assigned to them, and thus two lists of 35 people include two We will have an intervention and control group at random. For concealment, this method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by this person who is unaware of the division of groups.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Participant: In this study, we are not able to blind the patient, because patients of both interventions are aware of the type of intervention.
Clinical caregiver: We teach the person in charge of patient care and follow-up how to complete the questionnaire. This person has no knowledge of the type of patient intervention.
Researcher: In this study, we do not have the ability to blind the researcher, because the research does both studies himself and is aware of the type of intervention in each group.
Outcome Assessor: Completed questionnaires are given to a person who is not aware of the interventions performed and he / she is asked to determine the amount of stress, anxiety and depression reduction and increase general health in each person according to the questionnaire.
Data Analyzer: The questionnaires are finally given to a person to review the information after completing and collecting all the information. This person does not know any of the steps of the work and how to divide the intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-14, 1399/08/24
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.433
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Reduce general health of patient infected with Covid-19
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Timepoint
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The beginning and the end of the study.
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Method of measurement
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General health qustionnair (GHQ)
Secondary outcomes
1
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Description
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Function of patient
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Timepoint
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The beginning and the end of the study.
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Method of measurement
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Medical Research Council Breathlessness Scale (MRC dyspnea scale)
Intervention groups
1
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Description
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Intervention group: This group learns breathing exercises completely for a month through cyberspace (WhatsApp and Instagram). Then we will contact them regularly (two to three times a week) and answer their questions. Patients fill in the questionnaires at the beginning and end of the study. Patients exercise for one month and six days a week, three times a day and five times a day.
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Category
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Rehabilitation
2
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Description
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Intervention group: This group only receives educational pamphlets and basic trainings at the beginning of the month. But they are asked to do exercises 6 times a week, 3 times a day, 5 times a day. The difference is that we do not have much contact with patients during a month and only at the beginning and end of the study, the questionnaires are filled out by patients.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shiraz University of medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All available data can be shared after making people unidentifiable
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When the data will become available and for how long
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Access period starts 1year after the results are published.
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To whom data/document is available
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everyone can access to this information
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Under which criteria data/document could be used
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If the information in this study helps to improve the science process
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From where data/document is obtainable
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Drsheidashojaei@gmail.com 00989214783046
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What processes are involved for a request to access data/document
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After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.
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Comments
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