Telerehabilitation in COVID-19 Survivors

Overview

This study was carried out in the post-acute period of the telerehabilitation program in individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea, exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle oxygenation, fatigue and quality of life parameters.

Full Title of Study: “Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2022

Interventions

  • Other: telerehabilitation
    • While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
  • Other: home exercise program
    • While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
  • Other: informed program
    • will informed after COVID 19

Arms, Groups and Cohorts

  • Other: control group
    • While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.
  • Experimental: home exercise program group
    • this group will implement COVID 19 home exercise program.
  • Experimental: telerehabilitation group
    • this group will implement COVID 19 telerehabilitation program.

Clinical Trial Outcome Measures

Primary Measures

  • Severity of dyspnea assessment
    • Time Frame: 6 weeks
    • Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
  • Physical activity level assessment
    • Time Frame: 6 weeks
    • The physical activity level of the participants will be evaluated with the Turkish version of the “International Physical Activity Questionnaire” (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
  • Cardiopulmonary endurance assessment
    • Time Frame: 6 weeks
    • In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
  • Evaluation of peripheral muscle oxygenation
    • Time Frame: 6 weeks
    • “Moxy muscle oxygen monitor” will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
  • Pulmonary function (slow vital capacity)
    • Time Frame: 6 weeks
    • Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence.
  • Pulmonary function (Forced vital capacity (FVC))
    • Time Frame: 6 weeks
    • Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
  • Respiratory Muscle Strength
    • Time Frame: 6 weeks
    • Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
  • Activities of daily living assessment
    • Time Frame: 6 weeks
    • Barthel Index will be used to evaluate activities of daily living.
  • Muscle strength assessment
    • Time Frame: 6 weeks
    • Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
  • Perceived fatigue assessment
    • Time Frame: 6 weeks
    • Participants’ perceived fatigue level will be recorded using the “Fatigue Scale”. Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the “Fatigue Scale”. Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
  • General fatigue assessment
    • Time Frame: 6 weeks
    • Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
  • Quality of life assessment
    • Time Frame: 6 weeks
    • The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health.
  • Pulmonary function (Forced expiratory volume in the first second (FEV1))
    • Time Frame: 6 weeks
    • Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
  • Pulmonary function (FEV1 / FVC)
    • Time Frame: 6 weeks
    • Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
    • Time Frame: 6 weeks
    • Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
  • Pulmonary function (Peak flow rate (PEF)
    • Time Frame: 6 weeks
    • Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75, – Do not have any orthopedic or neurological disease that will affect exercise capacity, – Individuals who can take and execute verbal orders, – Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment, – Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house), – Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)), – Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale. Exclusion Criteria:

  • Those who have not had COVID-19 or acute period patients who are experiencing COVID-19, – Individuals who cannot be contacted, – Individuals with chronic heart disease, – Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%), – Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years), – Individuals with cerebrovascular disease in the last 6 months, – Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis, – Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR), – Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months, – Individuals who cannot walk independently, – Individuals with any mental illness that may prevent them from living independently or receiving treatment, – Uncooperative individuals for assessment and rehabilitation programs, – Those with alcohol or substance addiction, – Those who are pregnant, suspected of pregnancy or considering becoming pregnant, – Participants in another study within the last 3 months or currently.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bandırma Onyedi Eylül University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Canan Demir, Research Assistant – Bandırma Onyedi Eylül University
  • Overall Contact(s)
    • Canan Demir, +905458070601, canandemir@bandirma.edu.tr

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