Telerehabilitation Program in Persistent COVID-19

NCT ID: NCT04996212

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-10-14

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.

Conditions

Coronavirus Infection; Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Walking APP Group

Group Type: EXPERIMENTAL

Walking APP Group

Intervention Type: PROCEDURE

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.

Functional APP Group

Group Type: EXPERIMENTAL

Functional APP group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sara Cortés Amador

Valencia, , Spain

Countries

Spain

Other Identifiers

1573778

Identifier Type: -

Identifier Source: org_study_id