Telerehabilitation Program in Persistent COVID-19
- Conditions
- Coronavirus InfectionRespiratory Disease
- Interventions
- Procedure: Functional APP groupProcedure: Walking APP Group
- Registration Number
- NCT04996212
- Lead Sponsor
- University of Valencia
- Brief Summary
The syndrome characterized by the persistence of symptoms typical of COVID-19, beyond 4 weeks after discharge, is called long COVID. Long COVID affects a high percentage of patients who have suffered from COVID-19, regardless of its severity. The various symptoms present in that patients affect the functionality and physical, mental and psychological capacities of patients. Therefore, it is necessary to implement therapeutic programs, based on exercises and techniques of physiotherapy, to help affected people to resume their work, family, social and sports activities; prior to illness. Given the context in which these programs must be developed, telecare is positioned as the most recommended care method to carry out the rehabilitation of these patients. The general objective of this study is to evaluate the effectiveness of a cardiorespiratory tele-rehabilitation program in persistent COVID-19 patients. Study participants (n=60) will be randomly assigned to one of two intervention groups. Group 1 will combine breathing exercises with aerobic exercise: walk; and group 2 will perform functional exercises in addition to respiratory physiotherapy with. All participants will be evaluated at the beginning of the intervention, at the end of it.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Who have been diagnosed with coronavirus infection (PCR + and / or Antigen Test +).
- Have had a mild form of COVID-19 (absence of symptoms or mild symptoms without signs of viral pneumonia or hypoxia).
- Have overcome such infection; and continue to experience persistent symptoms, including dyspnea, fatigue, and / or functional limitation.
- Subjects suffering from other pulmonary or cardiac pathologies and / or diabetes, cancer.
- Individuals who required hospitalization, during the acute stage of infection;
- People who continue to obtain a positive PCR and / or positive Antigen Test;
- Those who have not been discharged by their doctor;
- Subjects who show serious symptoms and / or require medical supervision;
- Individuals with an inability to handle the internet and devices, such as mobile phones, computers or tablets; essential for telecare
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Functional APP Group Functional APP group - Walking APP Group Walking APP Group -
- Primary Outcome Measures
Name Time Method Quality of life (EQ-5D-5L) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation
- Secondary Outcome Measures
Name Time Method Fatigue Assessment Scale (FAS) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The scale consists of 10 items through which the fatigue experienced by the subject can be assessed at two levels: physical and mental.
Participants in this study must answer how often the situations described in each item on the scale occur. To do this, they must quantify each statement with a number from 1 to 5, where 1 is never; and 5, always.Hospital Anxiety and Depression Scale (HADS) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The HADS scale is a widely used instrument to assess the degree of emotional distress suffered by people with pathology. The scale consists of 14 items that consider cognitive, affective and behavioral aspects; but not somatic. The original version of the HADS has been validated and translated into different languages, including Spanish
London Chest Activity of Daily Living Scale (LCADL) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The LCADL was designed with the purpose of assessing the level of dyspnea, reported by patients with pulmonary pathology, during the performance of ADL. The LCADL scale therefore makes it possible to assess and adequately monitor the functional deterioration that patients experience as a consequence of their dyspnea. Throughout its development, this scale explores 4 different dimensions: self-care, home activities, physical activity and leisure activities.
Perceived Stress Scale (PSS) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The PSS allows evaluating the level of stress perceived by patients during the last month It is made up of 14 items that explore the thoughts and feelings of the respondent that can be related to high levels of stress. The higher the score, the higher the level of perceived stress.
Beck Depression Inventory (BDI-2) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The BDI-2, through its 21 items, aims to help the health professional to identify and measure the severity of symptoms, typical of a depressive process, in the adult population
Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS) It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention The PCFS items assess the functional limitations that post-COVID-19 patients The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation
Exercise tolerance. Thirty Seconds Sit-To-Stand It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Exercise tolerance will be assessed using the Thirty Seconds Sit-To-Stand test (30stst), as it has proven to be a useful test to evaluate the strength and endurance of the lower limbs and determine the patient's tolerance to physical activity
Trial Locations
- Locations (1)
Sara Cortés Amador
🇪🇸Valencia, Spain