Telerehabilitation Program and Detraining in Patients With Post-COVID-19 Sequelae

Effects of a Telerehabilitation Program and Detraining on Cardiorespiratory Fitness in Patients With Post-COVID-19 Sequelae

The primary objective of this study is to evaluate the effects of a 15-week home telerehabilitation program and a detraining period on cardiorespiratory fitness and muscular efficiency in patients with post-COVID-19 sequelae compared to a control group of COVID-19 patients. We hypothesize that cardiorespiratory fitness and muscular efficiency significantly improve in patients who carry out the home telerehabilitation program. However, the cardiorespiratory and muscular adaptations achieved and tolerance to exercise are lost over time as an effect of detraining.

Study Overview

• Status: Completed
• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Telerehabilitation program

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Boi De Llobregat, Barcelona, Spain, 08830
      • Manuel Vicente Garnacho Castaño

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age > 18 years
• molecular diagnosis (reverse transcription polymerase chain reaction [RT-PCR]) of infection by SARS-CoV-2
• post-COVID-19 symptomatology

Exclusion Criteria:

• severe neurological disease
• active oncological disease
• neuromuscular disease and/or orthopedic disorders impeding normal development of cardiopulmonary exercise test
• the absence of signed informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised home telerehabilitation program; COVID-19 patients will perform a total of 15 weeks of a telerehabilitation program combined with aerobic and strength exercises using the circuit training methodology. COVID-19 patients will carry out 3 weekly sessions on non-consecutive days to avoid unnecessary overload and maximize the adaptations, completing a total of 45 sessions	Other: Telerehabilitation program; The supervised telerehabilitation program will be performed in the home of each patient and supervised by an experienced physiotherapist with more than 4 years of clinical experience in therapeutic exercise for chronic diseases.
No Intervention: non-supervised control group; COVID-19 patients that will not perform the telerehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness: absolute oxygen uptake	absolute peak oxygen uptake in L/min	1 week per group
Cardiorespiratory fitness: relative oxygen uptake	relative peak oxygen uptake in L/min	1 week per group
Exercise capacity during cardiopulmonary exercise test	Exercise time in minutes and seconds	1 week per group
Mechanical efficiency	Delta efficiency in percentage	1 week per group
Ventilatory efficiency	VE/VCO2 slope	1 week per group
Power output during pedaling	Power output in watts	1 week per group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory exchange ratio	RER	1 week per group
Minute ventilation	Ventilation in L/min	1 week per group
ventilatory equivalent for oxygen	VE/VO2	1 week per group
ventilatory equivalent for carbon dioxide	VE/VCO2	1 week per group
End-tidal partial pressure of oxygen	PetO2 in mmHg	1 week per group
end-tidal partial pressure of carbon dioxide	PetCO2 in mmHg	1 week per group
Weight of COVID-19 patients	Weight in kg	1 week per group
Height of COVID-19 patients	Height in meters	1 week per group
Body mass index of COVID-19 patients	BMI in kg/m2	1 week per group

Collaborators and Investigators

• Sponsor: Campus docent Sant Joan de Déu-Universitat de Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Hospital of Mataró

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet decided

Drug and device information, study documents

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