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

Not Applicable

Not yet recruiting

• Conditions: Post-COVID-19 Syndrome

• Registration Number: NCT06814379
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study Start: 2025-02-03
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-05-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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: Short Physical Performance Battery (SPPB)	Through study completion, an average of 1 year	Ranges from 0 to 12, with higher scores indicating better performance.
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.
Adherence	Through study completion, an average of 1 year	Monitored via a diary, with adherence reported as the percentage of sessions completed.