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IRCT20200711048077N1 IRCT 2020-11-16 Mashhad University of Medical Sciences Evaluation of respiratory Tele-rehabilitation in patient with COVID-19 The impact of respiratory Tele-rehabilitation on pulmonary function and quality of life in patient with COVID-19 2020-11-21 anticipated 60 Complete https://irct.ir/trial/50721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization of study will done by generating a random sequence with randomization.com for each research unit in two groups alternatively. The envelope method in the package is used to hide the random sequence. In this way, a random sequence is written on small cards as code A or B and is kept in a closed envelope. Whenever a research unit is found to meet the inclusion criteria, it is opened in an envelope and entered the group based on the first card. Becomes relevant. This will continue until the required number of research units are assigned to both groups, Blinding description: Participants will be informed that generally there will be two different groups in the study, in one different pulmonary rehabilitation exercises will be performed online and in the other one pulmonary rehabilitation training will be given via pamphlet. Patients are then informed that they will be randomly assigned to one of two groups. The data collected from both groups will be provided to the data analyzer without specifying which control or test group it belongs to. N/A Coronavirus 2019. Intervention 1: Intervention group: For four weeks, every day for 30 minutes once a day for two set with 10 minutes of rest and hydration. The program includes one-minute diaphragmatic breathing exercises, 5-minute incentive spirometry exercises, 30-second sit to stand squats, 30-second standing marching, 30-second seated arm reaches, 30-second standing heel raises, 30-second sidestepping, 30- second Wall pushups. Individuals practice in groups of five on the Skyroom platform. Every day after training, the amount of fatigue and dyspenea based on the BORG scale, the number of exercises performed and problems during training in a special checklist for each The person is registered. Intervention 2: The usual training is done during discharge. They are given a training pamphlet on encouraging respiratory rehabilitation and spirometry exercises. Their condition is monitored daily by telephone. They are asked to record fatigue and shortness of breath and the number of exercises in the checklist. Yes - There is a plan to make this available What will be shared: In this study, all participants' data (demographic information, pulmonary function factors and questionnaire scores) will be available after being identified. When: Access period starts 3 months after the results are published. To whom: Researcher working in academic institutions Conditions: Academic researchers will be able to submit requests for data, and all quantitative and qualitative inferential and analytical analyzes of the data will be allowed. Where to obtain: Fatemeh Rangani. Ranganif981@mums.ac.ir How to obtain: The applicant must write a formal application to the corresponding author, announcing his/her application. After approval and coordination with the Vice Chancellor for Research, the study data will be sent to the applicant formally and confidentially. Comments:
public Fateme Rangani
No 10, Haft-e-Tir 5, Hafte-e-Tir Blvd, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9178846674 +98 51 3864 6372 ranganif981@mums.ac.ir Mashhad University of Medical Sciences scientific Fateme Rangani
No 10, Haft-e-Tir 5, Hafte-e-Tir Blvd, Vakilabad Blvd
mashhad Iran (Islamic Republic of) 9178846674 +98 51 3864 3672 ranganif981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Acceptable visual, auditory and alertness to participate in study Ability to understand and speak Persian Having online communication facilities such as internet and one of the smart devices such as laptop, tablet or smartphone. Ability to use online technology or caregiver to access it during quarantine. Patients who have been diagnosed with covid 19 and have a lung lesion based on the results of a CXR or CT scan with the approval of an infectious disease specialist Discharge after treatment Observance of social isolation Having a cardiac echo at the time of admission that indicates heart health 18 years 80 years Both Having deformity in the chest mental disorder Any severe illness that impairs the movement of patients such as severe heart disease, severe musculoskeletal pain, vascular aneurysms, severe neurological diseases Pregnancy vestibular disorders U07.1 COVID-19, virus identified Other Other Intervention group: For four weeks, every day for 30 minutes once a day for two set with 10 minutes of rest and hydration. The program includes one-minute diaphragmatic breathing exercises, 5-minute incentive spirometry exercises, 30-second sit to stand squats, 30-second standing marching, 30-second seated arm reaches, 30-second standing heel raises, 30-second sidestepping, 30- second Wall pushups. Individuals practice in groups of five on the Skyroom platform. Every day after training, the amount of fatigue and dyspenea based on the BORG scale, the number of exercises performed and problems during training in a special checklist for each The person is registered. The usual training is done during discharge. They are given a training pamphlet on encouraging respiratory rehabilitation and spirometry exercises. Their condition is monitored daily by telephone. They are asked to record fatigue and shortness of breath and the number of exercises in the checklist. Quality of life score in SF-36 questionnaire. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: SF-36 questionnaire. Pulmonary function. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: By examining the six-minute walk test and measuring the maximum inspiratory pressure (MIP) and the percentage of blood oxygen saturation (SPO2). Six-minute walking test (6mwt). Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: The patient walks a 30-meter flat path in six minutes and the distance is measured. Maximum inspiratory pressure (MIP). Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: En IMT K1 POWER BREATH device. Peripheral capillary oxygen saturation. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: Pulse Oximeter. Fatigue and dyspnea score. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: Borg scale 6-20. Mashhad University of Medical Sciences Approved 2020-09-15 Ethic committee of mashhad university of medical sciences No. 10, Hafte-e-Tir 5, Hafte-e-Tir Blvd, Vakil abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)