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

NCT05866224 | Completed

• 1 other identifier: Hospital of Mataró
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Respiratory exchange ratio

  1 week per group

• Minute ventilation

  1 week per group

• ventilatory equivalent for oxygen

  1 week per group

• ventilatory equivalent for carbon dioxide

  1 week per group

• End-tidal partial pressure of oxygen

  1 week per group

Study Arms (2)

Supervised home telerehabilitation program

EXPERIMENTAL

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

non-supervised control group

NO INTERVENTION

COVID-19 patients that will not perform the telerehabilitation program

Interventions

Telerehabilitation program OTHER

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.

Supervised home telerehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Manuel Vicente Garnacho Castaño

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the DAFNiS research group

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 19, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

ES (1)