Clinical trial NCT04996212: Telerehabilitation Program in Persistent COVID-19
Official title: Study of the Effectiveness of a Cardiorespiratory Telerehabilitation Program in Persistent COVID-19 Patients. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Respiratory Disease
Keywords: Covid-19
Physical Therapy
Dyspnea
Fatigue
Online Health
Functional Status
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life (EQ-5D-5L)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Secondary outcomes:
measure: Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: Fatigue Assessment Scale (FAS)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: London Chest Activity of Daily Living Scale (LCADL)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: Perceived Stress Scale (PSS)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: Beck Depression Inventory (BDI-2)
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
measure: Exercise tolerance. Thirty Seconds Sit-To-Stand
timeFrame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Sara Cortés Amador
Study officials:
References: