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Completed

NCT Number: NCT05205434

Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Telerehabilitation Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Maltepe, Istanbul, 34000, Turkey (Türkiye)

About this study

Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.

For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.

After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 patients in the subacute period discharged
  • Be 18 years or older
  • Having received oxygen therapy or mechanical ventilation support in the hospital
  • Access to online interviews and web-based exercises with a secure internet connection
  • Having sufficient speaking and hearing skills for telerehabilitation
  • Volunteer to participate in research

Exclusion criteria

  • Unstable clinical condition
  • Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
  • Inability to walk independently, even with an assistive device
  • Having serious neuromuscular problems
  • Not being cooperative enough to answer and understand questionnaires and scales

Treatment and study plan

Synchronous telerehabilitation programme

Other

Exercise program and educational program

Other names: Video conference

Asynchronous telerehabilitation programme

Other

Exercise program educational program

Other names: Mobil application

Primary outcomes

  1. Incremental Shuttle Walk Test (ISWT)

    Time frame: Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months

    The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).

Secondary outcomes

  1. 30-Second Chair Stand Test (30 CST)

    Time frame: Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months

    The patient will be asked to sit and stand as much as possible within 30 seconds, with his hands crossed over his chest. The number of sitting and staying for 30 seconds will be noted.

  2. Brief Physical Performance Battery (BPPB)

    Time frame: Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months

    It is a test used to evaluate the lower extremity function of patients. This battery represents the sum of 3 functional tests such as standing stance tests, 4 meters walking test and 5 times chair sit and stand (5STS). Each test is scored between 0 (not completing the test) and 4 (highest performance level)

Other outcomes

  1. Oxygen Saturation and Heart Rate

    Time frame: Change from baseline oxygen saturation (SaO2) and heart rate (beats per minute) of the patients at the end of the 8th week and, postintervation sixth months

    Participants' resting oxygen saturation and heart rate, and oxygen saturation and heart rate after the tests will be evaluated

  2. Dyspnea and Fatigue Level

    Time frame: Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months

    Participants' dyspnea and fatigue level, and dyspnea and fatigue level after the tests will be evaluated according to the Modified Borg (0-10) scale

  3. Timed Up-Go Test (TUG)

    Time frame: Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months

    Participants are asked to get up from the chair, walk 3 m at a comfortable and safe pace, return and sit back in the chair.

  4. International Physical Activity Questionnaire Short Form (IPAQ)

    Time frame: Change from baseline metabolic equivalent (MET)-minute/week of the patients at the end of the 8th week and, postintervation sixth months

    It is a scale used to determine the level of physical activity in adults. The scale questions vigorous and moderate physical activity, walking time of at least 10 minutes and daily sitting time in the last 7 days.

  5. Hospital Anxiety Depression (HAD) Scale

    Time frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months

    The questionnaire, which was filled in by the patient and includes the anxiety and depression subscales, consists of 14 items. Responses are scored between 0-3.

  6. Fatigue Severity Scale

    Time frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months

    This scale is a 9-item scale that measures the severity of fatigue in patients and its effect on one's activities and lifestyle. Responses are scored on a seven-point scale with 1 = strongly disagree and 7 = strongly agree.

  7. Quality of Life Scale: Short Form-36 (SF-36)

    Time frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months

    The self-assessment scale consists of 36 items and 8 sub-dimensions. The scale is evaluated considering the last four weeks. On the scale, 0 points indicate poor health and 100 points indicate good health.

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Collaborators

  • Marmara University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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