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CompletedNCT05866224Updated May 19, 2023

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

An interventional study of Telerehabilitation program in COVID-19 Acute Respiratory Distress Syndrome, sponsored by Campus docent Sant Joan de Déu-Universitat de Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Campus docent Sant Joan de Déu-Universitat de Barcelona · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2021, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

COVID-19

7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.

This study's enrollment of 130 is above the median of 100 across 4,100 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Campus docent Sant Joan de Déu-Universitat de Barcelona is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • 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

  • No intervention
    non-supervised control group

    COVID-19 patients that will not perform the telerehabilitation program

Interventions

  • OtherTelerehabilitation 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.

06

What researchers measure

Primary outcomes

  1. Cardiorespiratory fitness: absolute oxygen uptake

    absolute peak oxygen uptake in L/min

    Time frame: 1 week per group

  2. Cardiorespiratory fitness: relative oxygen uptake

    relative peak oxygen uptake in L/min

    Time frame: 1 week per group

  3. Exercise capacity during cardiopulmonary exercise test

    Exercise time in minutes and seconds

    Time frame: 1 week per group

  4. Mechanical efficiency

    Delta efficiency in percentage

    Time frame: 1 week per group

  5. Ventilatory efficiency

    VE/VCO2 slope

    Time frame: 1 week per group

  6. Power output during pedaling

    Power output in watts

    Time frame: 1 week per group

Secondary outcomes

  1. Respiratory exchange ratio

    RER

    Time frame: 1 week per group

  2. Minute ventilation

    Ventilation in L/min

    Time frame: 1 week per group

  3. ventilatory equivalent for oxygen

    VE/VO2

    Time frame: 1 week per group

  4. ventilatory equivalent for carbon dioxide

    VE/VCO2

    Time frame: 1 week per group

  5. End-tidal partial pressure of oxygen

    PetO2 in mmHg

    Time frame: 1 week per group

  6. end-tidal partial pressure of carbon dioxide

    PetCO2 in mmHg

    Time frame: 1 week per group

  7. Weight of COVID-19 patients

    Weight in kg

    Time frame: 1 week per group

  8. Height of COVID-19 patients

    Height in meters

    Time frame: 1 week per group

  9. Body mass index of COVID-19 patients

    BMI in kg/m2

    Time frame: 1 week per group

07

Study locations

1 site
  • Manuel Vicente Garnacho Castaño
    Sant Boi De Llobregat, Barcelona 08830, Spain
08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet decided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05866224
Lead sponsor
Campus docent Sant Joan de Déu-Universitat de Barcelona
Responsible party
Manuel Vicente Garnacho Castano (Coordinator of the DAFNiS research group, Campus docent Sant Joan de Déu-Universitat de Barcelona) — Principal investigator
First posted
May 19, 2023
Start date
Jan 1, 2021
Primary completion
Jan 1, 2023
Completion
May 1, 2023
Last update
May 19, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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