Digital Physiotherapy Practice in Long Covid-19 Patients

Study Overview
=================
Brief Summary
-----------------
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Long COVID-19 has been defined as the condition occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, with related symptoms lasting at least 2 months and not explainable by an alternative diagnosis. The practice of digital physiotherapy presents itself as a promising complementary treatment method to standard physiotherapy, playing a key role in the recovery of function in subjects who have passed the disease and who maintain some symptomatology over time. The aims of this research are to explore the effect of a digital physiotherapy intervention on functional recovery in patients diagnosed with Long COVID-19 and to identify the level of adherence to the treatment carried out. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. As secondary objectives, the aim is to identify the satisfaction and perception of patients with the intervention and the presence of barriers to its implementation (throught a qualitative research), as well as to evaluate the cost-effectiveness from the perspective of the health system. A quasi-experimental pre-post study assessed initially and at the end of the 4-week intervention the functional capacity (1-min STS and SPPB) and the adherence (software). The hypothesis of this research is that the implementation of a TR program presents positive results. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.

Detailed Description
-----------------
The authors hypothesised that the implementation of a digital physiotherapy intervention in Long COVID-19 participants is effective to improve the functional capacity and adherence and have positive results in patients satisfaction.

Official Title
-----------------
Digital Physiotherapy Practice in Long Covid-19 Patients to Improve Functional Capacity and Quality of Life.

Conditions
-----------------
Long COVID-19 Syndrome

Intervention / Treatment
-----------------
* Other: Digital Physiotherapy Practice (Telerehabilitation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over 18 years old Diagnosis: Long COVID-19 syndrome Residing in the Andalusian Community during the research period To have a computer technology with an internet connection aat home (personal computer, laptop, tablet or smartphone) Ability and knowledge to access email or whatsapp Exclusion Criteria: -Cognitive ability not suitable for the use of technological tools

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A quasi-experimental pre-post study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR Group<br>Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise | Other: Digital Physiotherapy Practice (Telerehabilitation)<br>* Online Physiotherapy services<br>* Other names: Telemedicine, ehealth;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | sit-to-stand test in 1 minute | Baseline (T0) | 
| Functional Capacity | sit-to-stand test in 1 minute | 4 weeks (T1) | 
| Functional Capacity (SPBB) short performance physical battery test | (SPBB) short performance physical battery test | Baseline (T0) | 
| Functional Capacity (SPBB) short performance physical battery test | (SPBB) short performance physical battery test | Baseline 4 weeks (T1) | 
| The Short Form Health Survey SF-12 | Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status) | Baseline (T0) | 
| The Short Form Health Survey SF-12 Quality of Live | The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status) | 4 weeks (T1) | 
| European Quality of Life-5 Dimensions EQ-5D | Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE). | Baseline (T0) | 
| European Quality of Life-5 Dimensions EQ-5D | Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE). | 4 weeks (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telemedicine Satisfaction Questionnaire (TSQ) | Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales | 4 weeks (T1) | 
| Cost-effectiveness of the telerehabilitation intervention | Direct Costs | 4 weeks T1 | 
| Adherence to intervention | Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription. | 4 weeks T1 | 
| Satisfaction and Perception with intervention | Qualitative interview | 4 weeks T1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Physiotherapy Practice (Telerehabilitation), Covid19 sequelae