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

September 11, 2026 updated by: CEU San Pablo University

Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients With Long COVID: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28003
        • CEU San Pablo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Usual care
Other: Usual Care
Usual care these patients may receive out from the clinical trial.
Experimental: Telerehabilitation program

The interventions include:

  • Education for self-management
  • Personalised exercise program
Other: Education for self-management
Education program performed online including information, recommendations and guidance for promoting self-management
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient activation measure 13
Time Frame: From enrollment to end of treatment and 3 months follow-up
Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13).
From enrollment to end of treatment and 3 months follow-up
self-care self-efficacy scale
Time Frame: From enrollment to end of treatment and 3 months follow-up
Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100.
From enrollment to end of treatment and 3 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life EuroQol-5D
Time Frame: From enrollment to end of treatment and 3 months follow-up

Quality of life related to dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Each dimension is described by three possible levels of problems (no, mild to moderate and severe). Hence, this descriptive system contains three or 243 combinations, or health states. For each of these combinations, one can assign healthstate utility indices (or ''preference weights'') which are based on different value sets.
From enrollment to end of treatment and 3 months follow-up
Fatigue Severity Scale (FSS)
Time Frame: From enrollment to end of treatment and 3 months follow-up
Severity of fatigue and its effect on a person's activities and lifestyle. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.
From enrollment to end of treatment and 3 months follow-up
DePaul Symptom Questionnaire-Short Form (DSQ-SF)
Time Frame: From enrollment to end of treatment and 3 months follow-up
The DSQ-SF allows investigators to use a small number of items (n = 14) to determine whether patients meet ME/CFS case definitions. Similar to the DSQ, the DSQ-SF uses the mean of the frequency and severity scores for each symptom rated over the past 6 months and linearly transforming it into a 100-point scale
From enrollment to end of treatment and 3 months follow-up
Semi-structured interview: Satisfaction and experience with the tele-rehabilitation program
Time Frame: From the end of treatment to 4 weeks

Data were collected through semi-structured interviews based on a question guide developed to obtain information on specific topics of interest: Satisfaction and user experience with the telerehabilitation program, Current goals and expectations and Social impact of the condition.

Only participants in the intervention group will be interviewed.
From the end of treatment to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEU San Pablo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

June 1, 2026

Study Completion (Actual)

September 1, 2026

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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