Long COVID SyndromePhase 2RESPICARENCT06822179
Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients With Long COVID
A Phase 2 study testing Education for self-management and Personalised exercise program in people with Long COVID Syndrome, run by CEU San Pablo University at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme roduces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long COVID Syndrome
- What is being tested?
- Education for self-management and Personalised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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 roduces 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:
Read more
- 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 (Exercise and education) + educational resources
- Conditions
- Long COVID Syndrome
- Being tested
- Education for self-management, Personalised exercise program, Usual Care
- Keywords
- post-acute COVID-19 syndrome, self-management, COVID-19, Rehabilitation, Exercise
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education for self-managementOther
Education program performed online including information, recommendations and guidance for promoting self-management
Personalised exercise programOther
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
Usual CareOther
Usual care these patients may receive out from the clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation program | Experimental | The interventions include: * Education for self-management * Personalised exercise program |
| Control | Active comparator | Usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient activation measure 13
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).
Measured: From enrollment to end of treatment and 3 months follow-up
self-care self-efficacy scale
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.
Measured: From enrollment to end of treatment and 3 months follow-up
Secondary outcomes (4)
Health-related quality of life EuroQol-5D
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.
Measured: From enrollment to end of treatment and 3 months follow-up
Fatigue Severity Scale (FSS)
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.
Measured: From enrollment to end of treatment and 3 months follow-up
DePaul Symptom Questionnaire-Short Form (DSQ-SF)
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
Measured: From enrollment to end of treatment and 3 months follow-up
Semi-structured interview: Satisfaction and experience with the tele-rehabilitation program
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.
Measured: From the end of treatment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822179
- Sponsor's protocol ID
- CEU-028
- Acronym
- RESPICARE
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients With Long COVID: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06822179
- Acronym / sponsor ID
- RESPICARE / CEU-028
- Conditions
- Long COVID Syndrome
- Keywords
- post-acute COVID-19 syndrome, self-management, COVID-19, Rehabilitation, Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme roduces 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 (Exercise and education) + educational resources
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation program | Experimental | –The interventions include: * Education for self-management * Personalised exercise program |
| Control | Active comparator | Other: Usual CareUsual care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education for self-managementEducation program performed online including information, recommendations and guidance for promoting self-management | Other | – |
| Personalised exercise programIndividualized 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 | Other | – |
| Usual CareUsual care these patients may receive out from the clinical trial. | Other | Control |
Primary outcome
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).
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.
4 secondary outcomes
Health-related quality of life EuroQol-5D
Time frame: 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
DePaul Symptom Questionnaire-Short Form (DSQ-SF)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Long COVID Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Education for self-management and Personalised exercise program in people with Long COVID Syndrome, run by CEU San Pablo University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient activation measure 13 (time frame: From enrollment to end of treatment and 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.