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IRCT20231207060287N1 IRCT 2024-01-28 Iran University of Medical Sciences Investigating the effects of physiotherapy on the treatment of post-Covid-19 syndrome complications Comparing the effects of pulmonary rehabilitation interventions, whole body vibration and cognitive-behavioral therapy on fatigue, dyspnea, physical function and quality of life in people with post-COVID-19 syndrome. A randomized clinical controlled trial 2024-02-20 anticipated 51 Complete https://irct.ir/trial/74278 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: In this study, we will use the restricted randomization method of the block balanced randomization type. In this method, the size of all the blocks is equal and we will have 6 blocks in this three-group experiment. The randomization tool is also used from random sequence generation software (Random allocation software), which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. For concealment, we use Concealment Allocation, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using opaque, sealed, numbered sequentially envelopes, in this method, each random sequence created is recorded on a card, and the cards are inside the letter envelopes. They are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. The process of random allocation will be done by someone outside the research team and before the start of the study, and since the therapist is not aware of the allocation of groups until the implementation of the intervention, the important feature of allocation concealment of RCT studies is observed in this study, Blinding description: In this study, the researcher who is in charge of treating patients is blind, and the process of dividing and placing each person in different groups will be done by someone other than the therapist. ​. N/A Complications of post-COVID-19 syndrome including fatigue and shortness of breath. Intervention 1: Control group: pulmonary rehabilitation. In this study, for pulmonary rehabilitation, we will use breathing exercises, stretching exercises and resistance exercises with elastic band along with encouragement to carry out care recommendations at home, during 6 weeks and 3 sessions per week.​. Intervention 2: The first intervention group: pulmonary rehabilitation with whole body vibration. In this study, for lung rehabilitation, we will use breathing exercises, stretching exercises and resistance exercises with an elastic band along with encouragement to carry out care recommendations at home, during 6 weeks and 3 sessions per week, and in addition to exercise the total tremor. The body is made of lanaform brand, POWER FULLS model and model number LA 57665, made in Belgium. Each whole body vibration training session consists of ten sets of one minute, using the device with a frequency of 35 Hz, after each one minute of using the device, the person rests for one minute. The whole body vibration training is done in 12 sessions twice a week in the morning. Intervention 3: The second intervention group: pulmonary rehabilitation with cognitive-behavioral therapy. In this study, we will use breathing exercises, stretching exercises and resistance exercises with an elastic band for pulmonary rehabilitation, along with encouraging to carry out care recommendations at home, during 6 weeks and 3 sessions per week, and in addition to cognitive behavioral therapy. Stark and Beck et al.'s model will be used. The sessions will be held in 6 weeks with 8 sessions (the first week (2 sessions), the second to fifth weeks (one session per week) and the last week (2 sessions)) for a duration of 45 minutes to one hour. Yes - There is a plan to make this available What will be shared: The individual data of the participants without mentioning their names and addresses, the protocols carried out in the study, the way of statistical analysis, statistical codes, data coding systems, consent forms, questionnaires and registered clinical reports are documents that can have sharing ​ When: Since the publication of the article and the publication of the results, access to the data is possible. ​ To whom: All people in scientific institutions, universities and research centers will be allowed to access the documents. Conditions: If the documents are provided to qualified people, whose goal is to use the data for the development of scientific activities and treatment protocols. ​ Where to obtain: To access the documents, people can contact the researcher's email at Fatemeh.menatnia@gmail.com. How to obtain: After receiving the request from the qualified people and providing the identity and scientific documents, the data files will be available to the applicants within one working week. Comments:
public Fatemeh Menatnia
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran ​
Tehran Iran (Islamic Republic of) 1341838771 +98 21 2226 9608 fatemeh.menatnia@gmail.com Iran University of Medical Sciences scientific Fatemeh Menatnia
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran ​
Tehran Iran (Islamic Republic of) 1341838771 +98 21 2226 9608 fatemeh.menatnia@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) People in the age range of 20 to 50 years People who have at least reading and writing literacy. (Having a primary degree) Patients who have been infected with Covid-19 for at least 3 months People with long-term covid diagnosis, according to C19-YRSm tool Patients who have not participated in any other intervention or training and rehabilitation program at the same time Individuals have no contraindications to exercise with a whole body vibration device (eg, vertigo, balance disorders, high blood pressure, severe osteoporosis, deep vein thrombosis, metal implants, pacemakers, epilepsy, tumors, arterial aneurysms, or arrhythmia)​ 20 years 50 years Both Pregnant women Patients with previous psychological disorders or undergoing psychiatric treatment Cardiovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity Any concurrent lung disease Patients who have suffered from other respiratory disease or other musculoskeletal disease during the last 12 months Hearing and vision impairment that may interfere with the implementation of procedures Heart rate at rest, more than 100 beats per minute If the patient's peripheral capillary oxygen saturation (SpO2) is less than 88% and does not resolve with rest, or if the patient has persistent symptoms such as heart palpitations, sweating, and shortness of breath, and the doctor determines that rehabilitation is inappropriate for him Other obstacles prohibiting the safety of sports Inability or unwillingness to continue cooperation in the study​ X, XIII, X Diseases of the respiratory system(X)، Diseases of the musculoskeletal system and connective tissue(XIII)، Factors influencing health status and contact with health services(XXI). Rehabilitation Rehabilitation Rehabilitation Control group: pulmonary rehabilitation. In this study, for pulmonary rehabilitation, we will use breathing exercises, stretching exercises and resistance exercises with elastic band along with encouragement to carry out care recommendations at home, during 6 weeks and 3 sessions per week.​ The first intervention group: pulmonary rehabilitation with whole body vibration. In this study, for lung rehabilitation, we will use breathing exercises, stretching exercises and resistance exercises with an elastic band along with encouragement to carry out care recommendations at home, during 6 weeks and 3 sessions per week, and in addition to exercise the total tremor. The body is made of lanaform brand, POWER FULLS model and model number LA 57665, made in Belgium. Each whole body vibration training session consists of ten sets of one minute, using the device with a frequency of 35 Hz, after each one minute of using the device, the person rests for one minute. The whole body vibration training is done in 12 sessions twice a week in the morning. The second intervention group: pulmonary rehabilitation with cognitive-behavioral therapy. In this study, we will use breathing exercises, stretching exercises and resistance exercises with an elastic band for pulmonary rehabilitation, along with encouraging to carry out care recommendations at home, during 6 weeks and 3 sessions per week, and in addition to cognitive behavioral therapy. Stark and Beck et al.'s model will be used. The sessions will be held in 6 weeks with 8 sessions (the first week (2 sessions), the second to fifth weeks (one session per week) and the last week (2 sessions)) for a duration of 45 minutes to one hour. Fatigue score in the Fatigue severity scale questionnaire. Timepoint: Measurements will be done once before the intervention, once immediately after the intervention and again 2 months after the last evaluation. Method of measurement: Fatigue severity scale questionnaire. Severity of shortness of breath in the Borg questionnaire. Timepoint: Measurements will be done once before the intervention, once immediately after the intervention and again 2 months after the last evaluation. Method of measurement: Borg shortness of breath severity questionnaire. Quality of life score through quality of life questionnaire. Timepoint: Measurements will be done once before the intervention, once immediately after the intervention and again 2 months after the last evaluation. Method of measurement: The 12-Item Short Form Health Survey (SF-12). Iran University of Medical Sciences Approved 2023-10-07 Ethics Committee of Iran University of Medical Sciences Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Maddkaran St., Shah Nazari St., Mader Square, Mirdamad, Tehran Tehran Tehran Iran (Islamic Republic of)