COVIDPERS: Telerehabilitation Program in Persistent COVID-19

Sponsor

University of Valencia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04996212

Collaborator

(none)

Enrollment

Location

Arms

23.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 = 120) will be randomly assigned to one of four intervention groups. Group 1 will receive a health education dossier; group 2 will perform breathing exercises; group 3 will combine breathing exercises with aerobic exercise; and group 4 will perform functional exercises, in addition to respiratory physiotherapy. All participants will be evaluated at the beginning of the intervention, at the end of it and 3 months later as a follow-up.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection Respiratory Disease	Procedure: Walking APP Group Procedure: Functional APP group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of the Effectiveness of a Cardiorespiratory Telerehabilitation Program in Persistent COVID-19 Patients. Randomized Clinical Trial.

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Walking APP Group	Procedure: Walking APP Group The participants of this group will be explained their treatment plan by a physiotherapist who will contact them through a video call. This treatment will consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of aerobic exercise: walking. Participants will consult their treatment plan through an application that will be installed on their mobile phone. They will start with 25 minutes of walking and will increase progressively until they reach 45 minutes. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment. Participants must perform the proposed exercises, 5 days a week, once a day In addition to the respiratory physiotherapy guideline, they will be given the health education manual.
Experimental: Functional APP Group	Procedure: Functional APP group The participants of this group will be explained their treatment regimen by a physiotherapist who will contact them through a video call. This treatment planwill consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of functional exercise which involve the activation and performance of large muscle groups. Participants will consult their treatment plan through an application that will be installed on their mobile phone. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment.

Arm

Intervention/Treatment

Experimental: Walking APP Group

Procedure: Walking APP Group

The participants of this group will be explained their treatment plan by a physiotherapist who will contact them through a video call. This treatment will consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of aerobic exercise: walking. Participants will consult their treatment plan through an application that will be installed on their mobile phone. They will start with 25 minutes of walking and will increase progressively until they reach 45 minutes. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment. Participants must perform the proposed exercises, 5 days a week, once a day In addition to the respiratory physiotherapy guideline, they will be given the health education manual.

Experimental: Functional APP Group

Procedure: Functional APP group

The participants of this group will be explained their treatment regimen by a physiotherapist who will contact them through a video call. This treatment planwill consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of functional exercise which involve the activation and performance of large muscle groups. Participants will consult their treatment plan through an application that will be installed on their mobile phone. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment.

Outcome Measures

Primary Outcome Measures

Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS) [It will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
The PCFS items assess the functional limitations that post-COVID-19 patients encounter when carrying out their usual daily activities. The scale also makes it possible to objectify the disabilities of each individual by assigning a grade between 0, absence of limitation and 4, severe functional limitations. The PCFS, therefore, is a useful tool to assess and quantify the severity of the consequences that COVID-19 has generated on the functional status of all subjects who have suffered it.

Secondary Outcome Measures

Quality of life (EQ-5D-3L) [It will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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
Fatigue Assessment Scale (FAS) [it will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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.
London Chest Activity of Daily Living Scale (LCADL) [it will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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.
Hospital Anxiety and Depression Scale (HADS) [it will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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
Perceived Stress Scale (PSS) [it will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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 three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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
Exercise tolerance. Thirty Seconds Sit-To-Stand [it will be evaluated in three moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention Follow-up: 2 months after completing the physiotherapy program.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, hypertension, cancer or hypercholesterolemia;
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