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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
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.
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.
University of Granada
Granada, Granada, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: 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.
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Time frame: Through study completion, an average of 1 year
Dyspnea. The Borg Modified Scale
Ranges from 0 to 10, with higher scores indicating greater dyspnea.
Time frame: Through study completion, an average of 1 year
Dyspnea. Dyspnea-12
Ranges from 0 to 36, with higher scores indicating greater dyspnea severity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Frailty: FRAIL Scale
Scores range from 0 to 5, with scores ≥3 indicating frailty.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Satisfaction with the Intervention
5-point Likert scale, with higher scores indicating greater satisfaction.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Adherence
Monitored via a diary, with adherence reported as the percentage of sessions completed.
Time frame: Through study completion, an average of 1 year