Telerehabilitation Program in Persistent COVID-19

NCT04996212 | Completed DMC

• 1 other identifier: 1573778
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Covid-19; Physical Therapy; Dyspnea; Fatigue; Online Health; Functional Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)

  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)

  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)

  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)

  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)

  It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention

Study Arms (2)

Walking APP Group

EXPERIMENTAL

Procedure: Walking APP Group

Functional APP Group

EXPERIMENTAL

Procedure: Functional APP group

Interventions

Walking APP Group 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.

Walking APP Group

Functional APP group 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.

Functional APP Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Sara Cortés Amador

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Coronavirus Infections; Respiration Disorders; COVID-19; Dyspnea; Fatigue

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 9, 2021
• Study Start: January 20, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: October 17, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)