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

NCT ID: NCT06822179

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-07-31

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

Conditions

Long COVID Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telerehabilitation program

The interventions include:

• Education for self-management
• Personalised exercise program

Group Type: EXPERIMENTAL

Education for self-management

Intervention Type: OTHER

Education program performed online including information, recommendations and guidance for promoting self-management

Personalised exercise program

Intervention Type: OTHER

Individualized exercise that includes progressive load adapted to each patient. It includes making flexible adjustments to their exercise (up or down as needed) to help them gradually improve their physical abilities while staying within their energy limits

Control

Usual care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care these patients may receive out from the clinical trial.

Interventions

Education for self-management

Education program performed online including information, recommendations and guidance for promoting self-management

Intervention Type: OTHER

Personalised exercise program

Individualized exercise that includes progressive load adapted to each patient. It includes making flexible adjustments to their exercise (up or down as needed) to help them gradually improve their physical abilities while staying within their energy limits

Intervention Type: OTHER

Usual Care

Usual care these patients may receive out from the clinical trial.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEU San Pablo University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CEU San Pablo University

Madrid, Madrid, Spain

Countries

Spain

Central Contacts

Aitor Martin Pintado Zugasti

Role: CONTACT

martinpintado@ceu.es

+34 913724700

Facility Contacts

Aitor Martin-Pintado Zugasti, Phd

Role: primary

martinpintado@ceu.es

+34913724700

Other Identifiers

CEU-028

Identifier Type: -

Identifier Source: org_study_id