Telerehabilitation Program in Persistent COVID-19 (COVIDPERS)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Respiratory Disease
• Intervention / Treatment: Procedure: Walking APP Group; Procedure: Functional APP group

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Sara Cortés Amador

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (EQ-5D-5L)	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	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)	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	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Fatigue Assessment Scale (FAS)	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.	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
London Chest Activity of Daily Living Scale (LCADL)	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.	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Hospital Anxiety and Depression Scale (HADS)	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	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Perceived Stress Scale (PSS)	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.	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Beck Depression Inventory (BDI-2)	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	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Exercise tolerance. Thirty Seconds Sit-To-Stand	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	It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Covid-19; Fatigue; Physical Therapy; Dyspnea; Functional Status; Online Health
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 1573778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are not to be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No