Clinical trial NCT06822179: Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID
Official title: Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Long COVID Syndrome
Keywords: post-acute COVID-19 syndrome
self-management
COVID-19
Rehabilitation
Exercise
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Patient activation measure 13
timeFrame: From enrollment to end of treatment and 3 months follow-up
measure: self-care self-efficacy scale
timeFrame: From enrollment to end of treatment and 3 months follow-up
Secondary outcomes:
measure: Health-related quality of life EuroQol-5D
timeFrame: From enrollment to end of treatment and 3 months follow-up
measure: Fatigue Severity Scale (FSS)
timeFrame: From enrollment to end of treatment and 3 months follow-up
measure: DePaul Symptom Questionnaire-Short Form (DSQ-SF)
timeFrame: From enrollment to end of treatment and 3 months follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU San Pablo University
Study officials:
References: