Telerehabilitation in COVID-19 Survivors

Not Applicable

Completed

• Conditions: Telerehabilitation; COVID-19
• Interventions: Other: home exercise program; Other: telerehabilitation; Other: informed program

• Registration Number: NCT05074979
• Lead Sponsor: Bandırma Onyedi Eylül University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-10-03
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-12
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home exercise program group	home exercise program	this group will implement COVID 19 home exercise program.
telerehabilitation group	telerehabilitation	this group will implement COVID 19 telerehabilitation program.
control group	informed program	While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.

Primary Outcome Measures

Name	Time	Method
Muscle strength assessment	6 weeks	Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
General fatigue assessment	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.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)	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.
Evaluation of peripheral muscle oxygenation	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.
Respiratory Muscle Strength	6 weeks	Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Quality of life assessment	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 (FEV1 / FVC)	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 (Peak flow rate (PEF)	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.
Physical activity level assessment	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.
Severity of dyspnea assessment	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.
Activities of daily living assessment	6 weeks	Barthel Index will be used to evaluate activities of daily living.
Perceived fatigue assessment	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.
Cardiopulmonary endurance assessment	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.
Pulmonary function (slow vital capacity)	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))	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.
Pulmonary function (Forced expiratory volume in the first second (FEV1))	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.

Trial Locations

Locations (1)

Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department; 🇹🇷 Balıkesir, Bandırma, Turkey