Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID (RESPICARE)

CEU San Pablo University

Status and phase: Not yet enrolling; Phase 2

Conditions: Long COVID Syndrome

Treatments: Other: Education for self-management; Other: Personalised exercise program; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06822179

CEU-028

Details and patient eligibility

About

The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID.

The main questions it aims to answer are:

• Will a multimodal program (exercise with education) improve the self-management ability of patients with post-exertional malaise?
• Does fatigue and quality of life will be improved in these patients?

Researchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise.

Participants will:

• Follow-up 12 weeks online sessions:

  1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources

• Daily use of the app: daily log, education and questions

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post COVID-19 condition: individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction
• Between 18 and 75 years of age
• Possibility of access and use of smartphone.
• Ability to attend the clinic in person for an initial session.

Exclusion criteria

• Patients with a history of respiratory or cardiovascular diseases prior to COVID-19, other acute or chronic diseases that may interfere with the study
• Pregnancy/breastfeeding
• Those with contraindications to respiratory muscle training.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Telerehabilitation program

Experimental group

Description:

The interventions include: * Education for self-management * Personalised exercise program

Treatment:

Other: Personalised exercise program

Other: Education for self-management

Control

Active Comparator group

Description:

Usual care

Treatment:

Other: Usual Care