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IRCT20140810018754N12 IRCT 2021-03-15 Iran University of Medical Sciences Effect of pulmonary tele-rehabilitation and progressive muscle relaxation training in COVID-19 patients Evaluation of the effect of pulmonary tele-rehabilitation with and without progressive muscle relaxation training on exercise capacity, anxiety and depression in COVID-19 patients after hospital discharge: a randomized clinical trial 2021-02-08 anticipated 52 Complete https://irct.ir/trial/54036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation is done by permuted block randomization method.The size of the blocks is twice the number of groups (four). The intervention group will be considered as A and the control group as B. We will have six blocks [AABB], [BBAA], [BABA], [ABAB], [BAAB] and [ABBA], numbered from one to six. Fourteen random numbers is needed to put the blocks together based on the sample size and the size of the blocks. Google random number generation will be used to get 14 random numbers (from one to six) and put the blocks together, Blinding description: Evaluator and patients in the study will be blinded during the entire process. The evaluator will be unaware of the study objectives and the randomized distribution of patients to study groups and will not have access to the randomization sequence. N/A COVID-19. Intervention 1: Intervention group: pulmonary telerehabilition with progressive muscle relaxation exercise. pulmonary rehabilitation includes breathing exercises, aerobic and resistance exercises. The relaxation exercise is based on Jacobsen's summarized method. The duration of the intervention is six weeks and the exercises are supervised by the physiotherapist through video call twice a week. Intervention 2: ِControl group: pulmonary telerehabilitation includes breathing exercises, aerobic and resistance exercises. The duration of the intervention is six weeks and the exercises are supervised by the physiotherapist through video call twice a week. Yes - There is a plan to make this available What will be shared: All data or results of the present study will be presented in an article or some articles that will be published, also will be avialable through correspondence with the corresponding author. When: After completing the present study and publishing the resulting article or articles To whom: All researchers in the field of the present study Conditions: With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences. Where to obtain: The corresponding author of the article or articles derived from this study How to obtain: Written request from the author responsible for the present review after the publication of the resulting article or articles Comments:
public Javad Sarrafzadeh
Department of physiotherapy, School of Rehabilitation Science, Iran University of Medical Sciences, Madadkaran st., Shahnazari st., Madar square., Mirdamad Ave, Tehran
Tehran Iran (Islamic Republic of) 1545913487 00982122228051-00982122227124 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences scientific Javad Sarrafzadeh
Department of physiotherapy, school of rehabilitation science of Iran university of medical science, Madadkaran st., Shahnazari st., Madar squ., Mirdamad Ave, Tehran
Tehran Iran (Islamic Republic of) 1545913487 00982122228051-00982122227124 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) COVID-19 confirmed with polymerase chain reaction test (PCR) Discharged from hospital (at least six days after the onset of symptoms) Patients who have to the ability to read and write in Persian Patients who access to the Internet and video call service 18 years 65 years Both Severe heart condition such as uncontrolled arrhythmias Chronic pulmonary and kidney condition Severe neurological condition such as guillan-barre, stroke and multiple sclerosis Uncontrolled diabetes or hypertension Smoker Athlete Pregnant women U07.1 COVID-19, virus identified Rehabilitation Rehabilitation Intervention group: pulmonary telerehabilition with progressive muscle relaxation exercise. pulmonary rehabilitation includes breathing exercises, aerobic and resistance exercises. The relaxation exercise is based on Jacobsen's summarized method. The duration of the intervention is six weeks and the exercises are supervised by the physiotherapist through video call twice a week. ِControl group: pulmonary telerehabilitation includes breathing exercises, aerobic and resistance exercises. The duration of the intervention is six weeks and the exercises are supervised by the physiotherapist through video call twice a week. Exercise capacity. Timepoint: before intervention, up to two and six week after intervention. Method of measurement: Six minute walk test. Dyspnea. Timepoint: Before intervention, up to two and six week after start of intervention. Method of measurement: 0-10 dyspnea Borg scale. Axiety. Timepoint: Before intervention and six weeks after start of intervention. Method of measurement: Hospital anxiety and depression scale. Sleep quality. Timepoint: Before intervention, six weeks after start of intervention. Method of measurement: Petersborg sleep quality questionaire. Quality of life. Timepoint: Before intervention, six weeks after start of intervention. Method of measurement: SF36, santgeorg respiratory questionaire. Fatigue severity. Timepoint: Before intervention, six weeks after start of intervention. Method of measurement: fatigue severity scale. Exercise capacity. Timepoint: Before intervention, six weeks after start of intervention. Method of measurement: repeated chair rise test during 30 seconds. Depression. Timepoint: Before intervention and six weeks after start of intervention. Method of measurement: Hospital anxiety and depression scale. Iran University of Medical Sciences Approved 2021-01-12 Ethics committee of Iran University of Medical Sciences 5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways, Tehran Tehran Tehran Iran (Islamic Republic of)