Telerehabilitation in COVID-19 Survivors

Sponsor
Bandırma Onyedi Eylül University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05074979
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
9.4
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: telerehabilitation
  • Other: home exercise program
  • Other: informed program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors
Anticipated Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Other: control group

While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.

Other: informed program
will informed after COVID 19

Experimental: home exercise program group

this group will implement COVID 19 home exercise program.

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.

Experimental: telerehabilitation group

this group will implement COVID 19 telerehabilitation program.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Respiratory Muscle Strength [6 weeks]

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.

  8. Activities of daily living assessment [6 weeks]

    Barthel Index will be used to evaluate activities of daily living.

  9. Muscle strength assessment [6 weeks]

    Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation DepartmentBalıkesirBandırmaTurkey10200

Sponsors and Collaborators

  • Bandırma Onyedi Eylül University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canan Demir, Research Assistant, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier:
NCT05074979
Other Study ID Numbers:
  • CDemir
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Canan Demir, Research Assistant, Bandırma Onyedi Eylül University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021