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

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telerehabilitation program
Sponsored by
Campus docent Sant Joan de Déu-Universitat de Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Manuel Vicente Garnacho Castaño

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supervised home telerehabilitation program

non-supervised control group

Arm Description

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

COVID-19 patients that will not perform the telerehabilitation program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Campus docent Sant Joan de Déu-Universitat de Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05866224
Brief Title
Telerehabilitation Program and Detraining in Patients With Post-COVID-19 Sequelae
Official Title
Effects of a Telerehabilitation Program and Detraining on Cardiorespiratory Fitness in Patients With Post-COVID-19 Sequelae
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus docent Sant Joan de Déu-Universitat de Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised home telerehabilitation program
Arm Type
Experimental
Arm Description
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
Arm Title
non-supervised control group
Arm Type
No Intervention
Arm Description
COVID-19 patients that will not perform the telerehabilitation program
Intervention Type
Other
Intervention Name(s)
Telerehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness: absolute oxygen uptake
Description
absolute peak oxygen uptake in L/min
Time Frame
1 week per group
Title
Cardiorespiratory fitness: relative oxygen uptake
Description
relative peak oxygen uptake in L/min
Time Frame
1 week per group
Title
Exercise capacity during cardiopulmonary exercise test
Description
Exercise time in minutes and seconds
Time Frame
1 week per group
Title
Mechanical efficiency
Description
Delta efficiency in percentage
Time Frame
1 week per group
Title
Ventilatory efficiency
Description
VE/VCO2 slope
Time Frame
1 week per group
Title
Power output during pedaling
Description
Power output in watts
Time Frame
1 week per group
Secondary Outcome Measure Information:
Title
Respiratory exchange ratio
Description
RER
Time Frame
1 week per group
Title
Minute ventilation
Description
Ventilation in L/min
Time Frame
1 week per group
Title
ventilatory equivalent for oxygen
Description
VE/VO2
Time Frame
1 week per group
Title
ventilatory equivalent for carbon dioxide
Description
VE/VCO2
Time Frame
1 week per group
Title
End-tidal partial pressure of oxygen
Description
PetO2 in mmHg
Time Frame
1 week per group
Title
end-tidal partial pressure of carbon dioxide
Description
PetCO2 in mmHg
Time Frame
1 week per group
Title
Weight of COVID-19 patients
Description
Weight in kg
Time Frame
1 week per group
Title
Height of COVID-19 patients
Description
Height in meters
Time Frame
1 week per group
Title
Body mass index of COVID-19 patients
Description
BMI in kg/m2
Time Frame
1 week per group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Manuel Vicente Garnacho Castaño
City
Sant Boi De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet decided

Learn more about this trial

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

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