Post-COVID-19 Syndrome
Conditions
Keywords
COVID-19, post-COVID-19 syndrome, fatigue
Brief 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.
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.
Interventions
BEHAVIORALRehabilitation
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.
BEHAVIORALVirtual reality based rehabilitation
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.
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * fatigue: FSS ≥ 36 puntos * basic knowledge * wish to participate in the study and sign the informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Impact | 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. |
| Perceived Fatigue | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea. Dyspnea-12 | Through study completion, an average of 1 year | Ranges from 0 to 36, with higher scores indicating greater dyspnea severity. |
| Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale | Through study completion, an average of 1 year | Ranges from 0 to 4, with higher scores indicating greater dyspnea severity. |
| Pain intensity | Through study completion, an average of 1 year | 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. |
| Psychological status | Through study completion, an average of 1 year | 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. |
| Sleep quality | Through study completion, an average of 1 year | 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. |
| Health-related Quality of life | Through study completion, an average of 1 year | To assess health-related quality of life using the EuroQol-5D (EQ-5D). Higher scores indicating better quality of life. |
| Functional status: Post-COVID-19 Functional Status (PCFS) | Through study completion, an average of 1 year | Ranges from 0 to 4, with higher scores indicating greater functional limitation. |
| Functional status: Patient-Specific Functional Scale (PSFS) | Through study completion, an average of 1 year | Scores range from 0 to 10, with higher scores indicating better functional status. |
| Frailty: Clinical Frailty Scale (CFS) | Through study completion, an average of 1 year | Ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty. |
| Frailty: FRAIL Scale | Through study completion, an average of 1 year | Scores range from 0 to 5, with scores ≥3 indicating frailty. |
| Physical activity | Through study completion, an average of 1 year | 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. |
| Exercise capacity: 2-Minute Walk Test | Through study completion, an average of 1 year | Measures the distance walked in meters; higher values indicate better capacity. |
| Exercise capacity: One-Legged Stand Test | Through study completion, an average of 1 year | Measures time in seconds; higher values indicate better balance and strength. |
| Exercise capacity: Arm Curl Test | Through study completion, an average of 1 year | Measures the number of arm curls completed in 30 seconds; higher values indicate better upper body strength. |
| Strength | Through study completion, an average of 1 year | To assess strength using dynamometry. Results are measured in kilograms (kg), with higher values indicating greater strength. |
| Motivation for Treatment | Through study completion, an average of 1 year | 15-item Treatment Self-Regulation Questionnaire (TSRQ). Scores range from 1 to 7 per item, with higher scores indicating greater autonomous motivation. |
| Treatment-Generated Motivation | Through study completion, an average of 1 year | 22-item Intrinsic Motivation Inventory (IMI). Scores range from 1 to 7 per item, with higher scores indicating greater intrinsic motivation. |
| Satisfaction with the Intervention | Through study completion, an average of 1 year | 5-point Likert scale, with higher scores indicating greater satisfaction. |
| Overall Perceived Effort | Through study completion, an average of 1 year | Modified Borg Scale, ranging from 0 to 10, with higher scores indicating greater effort. |
| Exercise capacity: Short Physical Performance Battery (SPPB) | Through study completion, an average of 1 year | Ranges from 0 to 12, with higher scores indicating better performance. |
| Adherence | Through study completion, an average of 1 year | Monitored via a diary, with adherence reported as the percentage of sessions completed. |
| COVID-19 information | Through study completion, an average of 1 year | 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. |
| Comorbidities | Through study completion, an average of 1 year | To assess comorbidities using the Charlson Comorbidity Index (CCI). Scores range from 0 to ≥6, with higher scores indicating greater comorbidity burden. |
| Dyspnea. The Borg Modified Scale | Through study completion, an average of 1 year | Ranges from 0 to 10, with higher scores indicating greater dyspnea. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORIrene Torres Sánchez, PhD
Universidad de Granada
Outcome results
None listed