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Telerehabilitation Program in Persistent COVID-19 (COVIDPERS)

Primary Purpose

Coronavirus Infection, Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Walking APP Group
Functional APP group
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring Covid-19, Physical Therapy, Dyspnea, Fatigue, Online Health, Functional Status

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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, 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

Sites / Locations

  • Sara Cortés Amador

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Walking APP Group

Functional APP Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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
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.
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
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

Full Information

First Posted
August 5, 2021
Last Updated
October 13, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04996212
Brief Title
Telerehabilitation Program in Persistent COVID-19
Acronym
COVIDPERS
Official Title
Study of the Effectiveness of a Cardiorespiratory Telerehabilitation Program in Persistent COVID-19 Patients. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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=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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Respiratory Disease
Keywords
Covid-19, Physical Therapy, Dyspnea, Fatigue, Online Health, Functional Status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sara Cortés Amador
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD are not to be shared with other researchers

Learn more about this trial

Telerehabilitation Program in Persistent COVID-19

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