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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Not intervention | |
| Rehabilitation | Experimental | 30-60 minutes. A total of 3 session/week at home. 4 weeks.
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Behavioral | 30-60 minutes. A total of 3 session/week at home. 4 weeks.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Torres Sánchez, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | Granada | 18016 | Spain |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Virtual reality based rehabilitation | Behavioral | 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:
|
|
| Comorbidities | To assess comorbidities using the Charlson Comorbidity Index (CCI). Scores range from 0 to ≥6, with higher scores indicating greater comorbidity burden. | Through study completion, an average of 1 year |
| Dyspnea. The Borg Modified Scale | Ranges from 0 to 10, with higher scores indicating greater dyspnea. | Through study completion, an average of 1 year |
| Dyspnea. Dyspnea-12 | Ranges from 0 to 36, with higher scores indicating greater dyspnea severity. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 1 year |
| Frailty: FRAIL Scale | Scores range from 0 to 5, with scores ≥3 indicating frailty. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 1 year |
| Satisfaction with the Intervention | 5-point Likert scale, with higher scores indicating greater satisfaction. | 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. | Through study completion, an average of 1 year |
| Adherence | Monitored via a diary, with adherence reported as the percentage of sessions completed. | Through study completion, an average of 1 year |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |