Tele-Physiotherapy After COVID-19 Hospitalization
Condition: Covid19; Coronavirus Disease 2019
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus
      2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.

      Tele-medicine is a tool to connect patients and health care professions while maintaining
      social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has
      the advantage of providing therapy.

      Since some months ago, different organizations have started the
      tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after
      COVID-19. This research team have developed a tele-rehabilitation guideline for
      physiotherapists to help them how to use tele-physiotherapy program for patients after
      COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of
      tele-physiotherapy program in patients discharged after COVID-19.
    

Detailed description: 
      Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus
      2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.

      Due to multisystem nature of this disease, it can cause a variety of early and late
      complications. New studies have revealed some of the long-term sequelae of this disease, such
      as neurological injuries, arterial or venous thrombosis, cardiac, brain strokes, etc. which
      need to be taken into consideration during management of patients. Many COVID-19 survivors
      who require critical care may also develop psychological, physical and cognitive impairments.
      These patients may develop various impairments because of hospitalization owing to extended
      immobilization and many hours bed ridden; these include neuromuscular complications, severe
      muscle weakness and fatigue, joint stiffness, dysphagia, psychological problems, reduced
      mobility, low quality of life, frequent falls, and even quadriparesis.

      Given impacts of COVID-19 on global health care system, innovative approaches in managing
      patients are needed. This is the reason that tele-medicine is becoming a trendy title for
      researchers . Tele-medicine is a tool to connect patients and health care professions while
      maintaining social distancing and restrictions . Digital health interventions can help
      provide self-monitoring tools, field updates, exercise protocols, and psychological support.
      Depending on the funding and facilities provided by the health care system, tele-medicine can
      be designed and employed in each country uniquely.

      Physiotherapy interventions can be also delivered through modern digital communication tools.
      Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy
      wherever is most convenient for the patient through the use of modern digital communication.

      Based on the evidences from other outbreak of viruses in the coronavirus strain epidemics,
      many of the discharged patients after COVID-19 pneumonia are likely to have residual
      impairment even some years after hospitalization. Not only discharged COVID-19 patients, but
      also other members of the society might need physiotherapy in this crisis. Despite this need,
      social distancing should be taken into account and human lives can't be put in danger.
      Tele-physiotherapy provides a great opportunity for therapists to communicate with their
      patients, assess and treat them.

      Since some months ago, different organizations have started the
      tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after
      COVID-19. This research team have developed a tele-rehabilitation guideline for
      physiotherapists to help them how to use tele-physiotherapy program for patients after
      COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of
      tele-physiotherapy program in patients discharged after COVID-19.
    

Intervention name(s): Tele-physiotherapy group; Control group
Intervention type(s): Other; Other
Intervention description(s): Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.; Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated to Tele-physiotherapy or control groups.
The sample size was calculated to identify clinically relevant effects on the primary outcome, the distance of six-minute walk test. The calculation was performed using STATA 16 software. Presuming a two-sided significance level (α) of 0.05, the power of 80% (β=0.20) and standard deviation based on the results of a relevant study in COVID-19 survivors which assessed the distance of six-minute walk test. Minimal clinically important difference (MCID) of 54m was reported and considered to be clinically significant. Repeated measurement of ANCOVA was used for the calculation with a baseline and two follow-up measurements (correlation of repeated measurement=0.499). After considering 20% possible participants attrition, It was determined that a sample size of 72 participants would be required to detect a significant change, 36 in each group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment