Post-COVID-19 SyndromeCOVIDATE-02NCT06814379
Rehabilitation of Fatigue in Patients With Post-COVID-19 Syndrome
A study testing Rehabilitation and Virtual reality based rehabilitation in people with Post-COVID-19 Syndrome, run by Universidad de Granada at 1 site in Spain.
Trial summary
More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom. The aim of this study is to conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Rehabilitation and Virtual reality based rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- 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
- diagnosis of COVID-19
- post-COVID-19 syndrome
- adults ≥ 18 y < 75 años
- be medically stable
- to be able to walk
- not currently participating in a rehabilitation programme and/or other study.
Show all 9Show fewer
- fatigue: FSS ≥ 36 puntos
- basic knowledge
- wish to participate in the study and sign the informed consent
Who cannot join
- patients with severe comorbidities that interfere with the ability to perform the study
- patients with mental, physical or organic problems that under medical criteria may pose a risk to the patient
Trial locations and contacts
1 site in 1 country.
About this study
More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.
The aim of this study is to conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.
Read the detailed description
- Background: More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.
- Objectives: To conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.
- Methodology: Randomized clinical trial. There will be 3 groups.
- Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.
- The evaluation will be carried out at the University of Granada.
- The rehabilitation will be carried out at the University of Granada and/or patient's home.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Rehabilitation, Virtual reality based rehabilitation
- Keywords
- COVID-19, post-COVID-19 syndrome, fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
30-60 minutes. A total of 3 session/week at home. 4 weeks.
- Warm-up.
- Aerobic: walking (20-25 minutes).
- Strength: (25-30 minutes).
- Cooling.
- Education: WHO recommendations.
Virtual reality based rehabilitationBehavioural
30-60 minutes. A total of 3 session/week (2 sessions at home and 1 session at the University of Granada). 4 weeks.
The 2 sessions at home will be the same as the sessions in the rehabilitation group (group 2).
The session at the University of Granada will be done with virtual reality (Nintendo Switch) and will follow the same outline as the rest of the sessions:
- Warm-up.
- Aerobic: walking (20-25 minutes).
- Strength: (25-30 minutes).
- Cooling.
- Education: WHO recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not intervention |
| Rehabilitation | Experimental | 30-60 minutes. A total of 3 session/week at home. 4 weeks.
* Warm-up.
* Aerobic: walking (20-25 minutes).
* Strength: (25-30 minutes).
* Cooling.
* Education: WHO recommendations. Receives: Behavioral: Rehabilitation |
| Virtual reality based rehabilitation | Experimental | 30-60 minutes. A total of 3 session/week (2 sessions at home and 1 session at the University of Granada). 4 weeks.
The 2 sessions at home will be the same as the sessions in the rehabilitation group (group 2).
The session at the University of Granada will be done with virtual reality (Nintendo Switch) and will follow the same outline as the rest of the sessions:
* Warm-up.
* Aerobic: walking (20-25 minutes).
* Strength: (25-30 minutes).
* Cooling.
* Education: WHO recommendations. Receives: Behavioral: Virtual reality based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Fatigue
To assess perceived fatigue using the borg modified scale.The scale ranges from 0 to 10, with higher scores indicating greater fatigue perception.
Measured: Through study completion, an average of 1 year
Multidimensional Fatigue
To assess multidimensional fatigue using the multidimensional fatigue inventory MFI-20). The scale comprises five subscales (General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation), each ranging from 4 to 20 points. Higher scores indicate greater fatigue.
Measured: Through study completion, an average of 1 year
Fatigue Severity
To assess fatigue severity using the fatigue severity scale (FSS). The total score ranges from 7 to 63 points, with higher scores indicating greater fatigue severity. A score of ≥36 is considered indicative of significant fatigue.
Measured: Through study completion, an average of 1 year
Fatigue Impact
To assess fatigue impact using the Modified Fatigue Impact Scale (MFIS). Scores range from 0 to 36, with higher scores indicating a greater impact of fatigue on daily activities.
Measured: Through study completion, an average of 1 year
Secondary outcomes (24)
COVID-19 information
To assess information about the date and symptoms when COVID-19 was diagnosed and the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS). The C19-YRS ranges from 0 to 10 per domain (physical, psychological, and functional symptoms). Higher scores indicate greater impairment.
Measured: Through study completion, an average of 1 year
Comorbidities
To assess comorbidities using the Charlson Comorbidity Index (CCI). Scores range from 0 to ≥6, with higher scores indicating greater comorbidity burden.
Measured: Through study completion, an average of 1 year
Dyspnea. The Borg Modified Scale
Ranges from 0 to 10, with higher scores indicating greater dyspnea.
Measured: Through study completion, an average of 1 year
Dyspnea. Dyspnea-12
Ranges from 0 to 36, with higher scores indicating greater dyspnea severity.
Measured: Through study completion, an average of 1 year
Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale
Ranges from 0 to 4, with higher scores indicating greater dyspnea severity.
Measured: Through study completion, an average of 1 year
Pain intensity
To assess pain intensity using the Visual Analogue Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Through study completion, an average of 1 year
Psychological status
To assess psychological status using the Hospital Anxiety and Depression Scale (HADS). The scale has two subscales (Anxiety and Depression), each ranging from 0 to 21. Scores of ≥11 on either subscale indicate clinically significant anxiety or depression.
Measured: Through study completion, an average of 1 year
Sleep quality
To assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A score >5 suggests significant sleep disturbances.
Measured: Through study completion, an average of 1 year
Health-related Quality of life
To assess health-related quality of life using the EuroQol-5D (EQ-5D). Higher scores indicating better quality of life.
Measured: Through study completion, an average of 1 year
Functional status: Post-COVID-19 Functional Status (PCFS)
Ranges from 0 to 4, with higher scores indicating greater functional limitation.
Measured: Through study completion, an average of 1 year
Functional status: Patient-Specific Functional Scale (PSFS)
Scores range from 0 to 10, with higher scores indicating better functional status.
Measured: Through study completion, an average of 1 year
Frailty: Clinical Frailty Scale (CFS)
Ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty.
Measured: Through study completion, an average of 1 year
Frailty: FRAIL Scale
Scores range from 0 to 5, with scores ≥3 indicating frailty.
Measured: Through study completion, an average of 1 year
Physical activity
To assess physical activity using the International Physical Activity Questionnaire (IPAQ). This measure assesses types and intensities of physical activity, yielding results in MET-min/week. Higher values indicate greater physical activity levels.
Measured: Through study completion, an average of 1 year
Exercise capacity: Short Physical Performance Battery (SPPB)
Ranges from 0 to 12, with higher scores indicating better performance.
Measured: Through study completion, an average of 1 year
Exercise capacity: 2-Minute Walk Test
Measures the distance walked in meters; higher values indicate better capacity.
Measured: Through study completion, an average of 1 year
Exercise capacity: One-Legged Stand Test
Measures time in seconds; higher values indicate better balance and strength.
Measured: Through study completion, an average of 1 year
Exercise capacity: Arm Curl Test
Measures the number of arm curls completed in 30 seconds; higher values indicate better upper body strength.
Measured: Through study completion, an average of 1 year
Strength
To assess strength using dynamometry. Results are measured in kilograms (kg), with higher values indicating greater strength.
Measured: Through study completion, an average of 1 year
Motivation for Treatment
15-item Treatment Self-Regulation Questionnaire (TSRQ). Scores range from 1 to 7 per item, with higher scores indicating greater autonomous motivation.
Measured: Through study completion, an average of 1 year
Treatment-Generated Motivation
22-item Intrinsic Motivation Inventory (IMI). Scores range from 1 to 7 per item, with higher scores indicating greater intrinsic motivation.
Measured: Through study completion, an average of 1 year
Satisfaction with the Intervention
5-point Likert scale, with higher scores indicating greater satisfaction.
Measured: Through study completion, an average of 1 year
Overall Perceived Effort
Modified Borg Scale, ranging from 0 to 10, with higher scores indicating greater effort.
Measured: Through study completion, an average of 1 year
Adherence
Monitored via a diary, with adherence reported as the percentage of sessions completed.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start3 Feb 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Torres Sánchez, Universidad de Granada
- Investigators
- Irene Torres Sánchez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814379
- Sponsor's protocol ID
- COVIDATE-02
- Acronym
- COVIDATE-02
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Fatigue in Patients With Post-COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT06814379
- Acronym / sponsor ID
- COVIDATE-02 / COVIDATE-02
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- COVID-19, post-COVID-19 syndrome, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 7 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.
More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.
The aim of this study is to conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.
Detailed description
- Background: More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.
- Objectives: To conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.
- Methodology: Randomized clinical trial. There will be 3 groups.
- Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.
- The evaluation will be carried out at the University of Granada.
- The rehabilitation will be carried out at the University of Granada and/or patient's home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Not intervention |
| Rehabilitation | Experimental | Behavioral: Rehabilitation30-60 minutes. A total of 3 session/week at home. 4 weeks. * Warm-up. * Aerobic: walking (20-25 minutes). * Strength: (25-30 minutes). * Cooling. * Education: WHO recommendations. |
| Virtual reality based rehabilitation | Experimental | Behavioral: Virtual reality based rehabilitation30-60 minutes. A total of 3 session/week (2 sessions at home and 1 session at the University of Granada). 4 weeks. The 2 sessions at home will be the same as the sessions in the rehabilitation group (group 2). The session at the University of Granada will be done with virtual reality (Nintendo Switch) and will follow the same outline as the rest of the sessions: * Warm-up. * Aerobic: walking (20-25 minutes). * Strength: (25-30 minutes). * Cooling. * Education: WHO recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- diagnosis of COVID-19
- post-COVID-19 syndrome
- adults ≥ 18 y < 75 años
- be medically stable
- to be able to walk
Key exclusion criteria (2 listed)
- patients with severe comorbidities that interfere with the ability to perform the study
- patients with mental, physical or organic problems that under medical criteria may pose a risk to the patient
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 |
|---|---|---|
| Rehabilitation30-60 minutes. A total of 3 session/week at home. 4 weeks. * Warm-up. * Aerobic: walking (20-25 minutes). * Strength: (25-30 minutes). * Cooling. * Education: WHO recommendations. | Behavioural | Rehabilitation |
| Virtual reality based rehabilitation30-60 minutes. A total of 3 session/week (2 sessions at home and 1 session at the University of Granada). 4 weeks. The 2 sessions at home will be the same as the sessions in the rehabilitation group (group 2). The session at the University of Granada will be done with virtual reality (Nintendo Switch) and will follow the same outline as the rest of the sessions: * Warm-up. * Aerobic: walking (20-25 minutes). * Strength: (25-30 minutes). * Cooling. * Education: WHO recommendations. | Behavioural | Virtual reality based rehabilitation |
Primary outcome
Perceived Fatigue
Time frame: Through study completion, an average of 1 year
To assess perceived fatigue using the borg modified scale.The scale ranges from 0 to 10, with higher scores indicating greater fatigue perception.
Multidimensional Fatigue
Time frame: Through study completion, an average of 1 year
To assess multidimensional fatigue using the multidimensional fatigue inventory MFI-20). The scale comprises five subscales (General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation), each ranging from 4 to 20 points. Higher scores indicate greater fatigue.
Fatigue Severity
Time frame: Through study completion, an average of 1 year
To assess fatigue severity using the fatigue severity scale (FSS). The total score ranges from 7 to 63 points, with higher scores indicating greater fatigue severity. A score of ≥36 is considered indicative of significant fatigue.
Fatigue Impact
Time frame: Through study completion, an average of 1 year
To assess fatigue impact using the Modified Fatigue Impact Scale (MFIS). Scores range from 0 to 36, with higher scores indicating a greater impact of fatigue on daily activities.
24 secondary outcomes
COVID-19 information
Time frame: Through study completion, an average of 1 year
Comorbidities
Time frame: Through study completion, an average of 1 year
Dyspnea. The Borg Modified Scale
Time frame: Through study completion, an average of 1 year
Dyspnea. Dyspnea-12
Time frame: Through study completion, an average of 1 year
Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Through study completion, an average of 1 year
Pain intensity
Time frame: Through study completion, an average of 1 year
Psychological status
Time frame: Through study completion, an average of 1 year
Sleep quality
Time frame: Through study completion, an average of 1 year
Health-related Quality of life
Time frame: Through study completion, an average of 1 year
Functional status: Post-COVID-19 Functional Status (PCFS)
Time frame: Through study completion, an average of 1 year
Functional status: Patient-Specific Functional Scale (PSFS)
Time frame: Through study completion, an average of 1 year
Frailty: Clinical Frailty Scale (CFS)
Time frame: Through study completion, an average of 1 year
Frailty: FRAIL Scale
Time frame: Through study completion, an average of 1 year
Physical activity
Time frame: Through study completion, an average of 1 year
Exercise capacity: Short Physical Performance Battery (SPPB)
Time frame: Through study completion, an average of 1 year
Exercise capacity: 2-Minute Walk Test
Time frame: Through study completion, an average of 1 year
Exercise capacity: One-Legged Stand Test
Time frame: Through study completion, an average of 1 year
Exercise capacity: Arm Curl Test
Time frame: Through study completion, an average of 1 year
Strength
Time frame: Through study completion, an average of 1 year
Motivation for Treatment
Time frame: Through study completion, an average of 1 year
Treatment-Generated Motivation
Time frame: Through study completion, an average of 1 year
Satisfaction with the Intervention
Time frame: Through study completion, an average of 1 year
Overall Perceived Effort
Time frame: Through study completion, an average of 1 year
Adherence
Time frame: Through study completion, an average of 1 year
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Irene Torres Sánchez, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and Virtual reality based rehabilitation in people with Post-COVID-19 Syndrome, run by Universidad de Granada 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 9 inclusion and 2 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 26 Jan 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.
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?
Perceived Fatigue (time frame: Through study completion, an average of 1 year). The study lists 4 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 26 Jan 2026.