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IRCT20201102049234N2 IRCT 2021-10-26 Semnan University of Medical Sciences The Effect of Functional Electrical Stimulation Intervention in Treatment of Older Adults with COVID-19 COVID-19 The Effect of Functional Electrical Stimulation Intervention on Fatigue, Muscle Strength, Muscle Mass and Quality of Life in Older Adults with COVID-19 2021-10-02 anticipated 40 Complete https://irct.ir/trial/58793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with a random number table such that each person is given a code and they are written in a table. We select one place from the table in a blinded manner. Then we select 12 numbers smaller than the selected number in the same row. The same would be true for the treatment and control group, Blinding description: The researcher will be blind to the intervention using the research assistant and he/she is absent in the treatment room. The outcome evaluator will vary with the researcher and research data be given him with code and is unaware of the participants intervention. N/A Coronavirus disease (COVID-19). Intervention 1: Intervention group: The first group will receive functional electrical stimulation during 10 sessions of rehabilitation treatment. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator (710 P-plus, Iran) with pairs of electrodes (10 × 5 cm) placed transversally on the quadriceps muscle (5 cm below the inguinal crease and 5 cm above the patella). The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 μs). The total duration of the FES session is 30 minutes. Thus eliciting a total of 90 evoked contractions per day. Stimulation intensity will adjust daily by the physical therapist to elicit a visible twitch in each muscle. The maximal stimulation intensity will record for each session and considered as a surrogate marker of FES dose. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator with pairs of electrodes (10 × 5 cm) placed transversally on the anterior tibialis muscle. One electrode will place over the motor point of the TA muscle and the other will place immediately below the belly of the muscle. FES will be apply for 20 minutes (pulse duration μs) with a frequency of 50 Hz. Intervention 2: Control group: The second intervention group will receive sham functional electrical stimulation during 10 sessions of rehabilitation treatment. Sham FES will follow the same procedures, but the device will switch on only for the initial 20 seconds, with the current then diminish to zero. The patients will inform of the possibility of feeling a slight initial tingling that would either diminish, disappear or continue during the 20-minute session. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are not more informations
public Fariba Ramezani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 mona.ramezani.sa@gmail.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Elderly People with COVID-19 After Hospital Discharge Age Over 60 Years Obvious Atrophy of the Quadriceps and Tibialis Anterior Muscles Normal Level of Alertness ,Orientation and Responsiveness to Verbal Stimulus To Be Willing to Participate in the Study 60 years no limit Both Pregnancy Known or Suspected Malignancy in the Lower Limb Body Mass Index Equal or Greater than 35 Kilogram Per Square Meter Conditions Preventing Electrical Stimulation Treatment for Example Deep Vein Thrombosis and Rhabdomyolysis Skin Lesions at the Site of Electrical Stimulation Diagnosis of Alzheimer's Disease, Degenerative Disease and Polyneuropathy Conditions Preventing Outcome Assessment for Example Amputation or Inability to Walk Presence of an Implanted Cardiac Pacemaker or Defibrillator U07.1 COVID-19, virus identified Treatment - Devices Treatment - Devices Intervention group: The first group will receive functional electrical stimulation during 10 sessions of rehabilitation treatment. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator (710 P-plus, Iran) with pairs of electrodes (10 × 5 cm) placed transversally on the quadriceps muscle (5 cm below the inguinal crease and 5 cm above the patella). The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 μs). The total duration of the FES session is 30 minutes. Thus eliciting a total of 90 evoked contractions per day. Stimulation intensity will adjust daily by the physical therapist to elicit a visible twitch in each muscle. The maximal stimulation intensity will record for each session and considered as a surrogate marker of FES dose. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator with pairs of electrodes (10 × 5 cm) placed transversally on the anterior tibialis muscle. One electrode will place over the motor point of the TA muscle and the other will place immediately below the belly of the muscle. FES will be apply for 20 minutes (pulse duration μs) with a frequency of 50 Hz. Control group: The second intervention group will receive sham functional electrical stimulation during 10 sessions of rehabilitation treatment. Sham FES will follow the same procedures, but the device will switch on only for the initial 20 seconds, with the current then diminish to zero. The patients will inform of the possibility of feeling a slight initial tingling that would either diminish, disappear or continue during the 20-minute session. Fatigue. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Chalder fatigue questionnaire. Muscle Strength. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Biofeedback pressure device. Muscle Mass. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Ultrasonographic device. Quality of Life. Timepoint: Before the intervention and one month after the start of intervention. Method of measurement: WHOQOL-BREF questionnaire. Semnan University of Medical Sciences Approved 2021-09-28 Ethics committee of Semnan University of Medical Sciences Headquarters of Semnan University of Medical Sciences, Basij Blvd., Semnan Semnan Semnan Iran (Islamic Republic of)