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Completed

NCT Number: NCT06814379

Rehabilitation of Fatigue in Patients With Post-COVID-19 Syndrome

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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Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18016, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation

Behavioral

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 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:

  • Warm-up.
  • Aerobic: walking (20-25 minutes).
  • Strength: (25-30 minutes).
  • Cooling.
  • Education: WHO recommendations.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. COVID-19 information

    Time frame: 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.

  2. Comorbidities

    Time frame: 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.

  3. Dyspnea. The Borg Modified Scale

    Time frame: Through study completion, an average of 1 year

    Ranges from 0 to 10, with higher scores indicating greater dyspnea.

  4. Dyspnea. Dyspnea-12

    Time frame: Through study completion, an average of 1 year

    Ranges from 0 to 36, with higher scores indicating greater dyspnea severity.

  5. Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: Through study completion, an average of 1 year

    Ranges from 0 to 4, with higher scores indicating greater dyspnea severity.

  6. Pain intensity

    Time frame: 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.

  7. Psychological status

    Time frame: 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.

  8. Sleep quality

    Time frame: 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.

  9. Health-related Quality of life

    Time frame: 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.

  10. Functional status: Post-COVID-19 Functional Status (PCFS)

    Time frame: Through study completion, an average of 1 year

    Ranges from 0 to 4, with higher scores indicating greater functional limitation.

  11. Functional status: Patient-Specific Functional Scale (PSFS)

    Time frame: Through study completion, an average of 1 year

    Scores range from 0 to 10, with higher scores indicating better functional status.

  12. Frailty: Clinical Frailty Scale (CFS)

    Time frame: Through study completion, an average of 1 year

    Ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty.

  13. Frailty: FRAIL Scale

    Time frame: Through study completion, an average of 1 year

    Scores range from 0 to 5, with scores ≥3 indicating frailty.

  14. Physical activity

    Time frame: 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.

  15. Exercise capacity: Short Physical Performance Battery (SPPB)

    Time frame: Through study completion, an average of 1 year

    Ranges from 0 to 12, with higher scores indicating better performance.

  16. Exercise capacity: 2-Minute Walk Test

    Time frame: Through study completion, an average of 1 year

    Measures the distance walked in meters; higher values indicate better capacity.

  17. Exercise capacity: One-Legged Stand Test

    Time frame: Through study completion, an average of 1 year

    Measures time in seconds; higher values indicate better balance and strength.

  18. Exercise capacity: Arm Curl Test

    Time frame: 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.

  19. Strength

    Time frame: 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.

  20. Motivation for Treatment

    Time frame: 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.

  21. Treatment-Generated Motivation

    Time frame: 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.

  22. Satisfaction with the Intervention

    Time frame: Through study completion, an average of 1 year

    5-point Likert scale, with higher scores indicating greater satisfaction.

  23. Overall Perceived Effort

    Time frame: Through study completion, an average of 1 year

    Modified Borg Scale, ranging from 0 to 10, with higher scores indicating greater effort.

  24. Adherence

    Time frame: Through study completion, an average of 1 year

    Monitored via a diary, with adherence reported as the percentage of sessions completed.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Acronym: COVIDATE-02

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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