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

Sponsor

Campus docent Sant Joan de Déu-Universitat de Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT05866224

Collaborator

(none)

130

Enrollment

Location

Arms

27.9

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome	Other: Telerehabilitation program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manuel Vicente Garnacho Castaño	Sant Boi De Llobregat	Barcelona	Spain	08830

Sponsors and Collaborators

Campus docent Sant Joan de Déu-Universitat de Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manuel Vicente Garnacho Castano, Coordinator of the DAFNiS research group, Campus docent Sant Joan de Déu-Universitat de Barcelona

ClinicalTrials.gov Identifier:

NCT05866224

Other Study ID Numbers:

Hospital of Mataró

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of May 19, 2023