Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient
Condition: Coronavirus; Fatigue; Musculoskeletal Complication
MeSH terms: Coronavirus Infections
Study type: Interventional

Summary: 
      SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its
      evolution can range from an asymptomatic course, to rapidly evolve and cause an acute
      respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the
      neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively
      influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is
      recommended that early post-acute rehabilitation be continued after the hospital phase to
      increase levels of physical activity, which can also be continued with long-term
      telerehabilitation.

      This project would offer a free service of asynchronous physical telerehabilitation for the
      patient that is easy to implement and follow up.

      For this purpose, patients will be recruited at the time of discharge from the Hospital
      Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza
      and two intervention groups with the same physical therapy and educational programme will be
      carried out. The experimental group will be carried out by means of home telerehabilitation,
      while the control group will receive the programme in an explanatory booklet.

      The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week
      physical therapy and therapeutic education programme using asynchronous telerehabilitation in
      post-COVID-19 patients, and to compare its effects with patients who have undergone the same
      programme, but in a non-telematic format.

      The secondary objective is to analyze the feasibility of a physical home-based asynchronous
      telerehabilitation programme in post-COVID-19 patients.

      Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic
      education using asynchronous telerehabilitation software is feasible and preliminarily
      effective in increasing physical fitness as well as adherence to treatment, and in the
      improvement of psychosocial factors.
    

Detailed description: 
      At the first phase, an observational study aims to investigate the physical and psychological
      status of patients after hospital discharge.

      At the second phase, a feasibility pilot study with a single-blinded randomized clinical
      trial design with volunteer patients admitted to hospital and recruited at the time of
      discharge by COVID-19 will evaluate a physiotherapy programme. There will be an intervention
      group (asynchronous telerehabilitation at home) and a control group (home rehabilitation by
      means of an explanatory leaflet). The intervention will be carried out for 12 weeks with a
      follow-up at 3 and 6 months.

      Intervention:

      The physical rehabilitation programme will be designed with three levels of intensity of
      aerobic, strength and respiratory exercises, and a list of recommendations for
      self-management of the sequelae of the COVID-19.

      The intervention will last for a total of 12 weeks at home (three days a week for 45-60
      minutes a day) with a biweekly phone check-up.

      All patients will be provided with the same physical rehabilitation and educational
      programme, with each allocation group differing in the format of the prescription.

      Experimental group

      A programme with exercise videos and health recommendations will be prescribed through a
      telerehabilitation platform to improve fatigue and fitness resulting from COVID-19. The
      application will be installed on patients' mobile phones and its use will be explained to
      them so that they can carry out the programme from their homes.

      Control group The control group will receive a paper booklet with clear pictures and
      descriptions of the exercise and educative programme to improve fatigue and fitness.

      Assessment:

      Fatigue will be assessed with the fatigue severity scale (FSS). Functional capacity will be
      measured through operation: with the Post-COVID Functional Status Scale (PCFS), the strength
      with the 30" sit-to-stand (STST), the 30" arm curl test (ACT), and through aerobic capacity
      with de six minutes walking test (6MWT).

      Psychosocial factors will be measured with the general self-efficacy scale (GSES), the
      depression and anxiety scale (DASS-21), the behavioral regulation questionnaire in sport
      (BRSQ) and the multidimensional scale of perceived social support (MSPSS).

      Quality of life will be measured with the quality of life scale (SF-12).

      Adherence and engagement be measured by diary recording and satisfaction with a brief
      interview.

      Outcome measures:

      Fatigue, functional status post-COVID-19, strength, aerobic capacity, anxiety and depression,
      behavior in sport, perceived social support and quality of life will be evaluated before
      intervention, after intervention (12 weeks) at 3 and 6 months for follow-up.

      Adherence and satisfaction will be evaluated after intervention (12 weeks) and during
      intervention (each 15 days).
    

Intervention name(s): Asynchronous telerehabilitation programme; Rehabilitation programme
Intervention type(s): Other; Other
Intervention description(s): Home-based physical rehabilitation programme using a telerehabilitation platform; Home-based physical rehabilitation programme by means of an explanatory booklet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronavirus; Telerehabilitation; Exercise Therapy; Education