Rehabilitation of Fatigue in Patients With Post-COVID-19 Syndrome
COVIDATE-02
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJanuary 26, 2026
February 1, 2025
6 months
January 28, 2025
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (24)
COVID-19 information
Through study completion, an average of 1 year
Comorbidities
Through study completion, an average of 1 year
Dyspnea. The Borg Modified Scale
Through study completion, an average of 1 year
Dyspnea. Dyspnea-12
Through study completion, an average of 1 year
Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale
Through study completion, an average of 1 year
- +19 more secondary outcomes
Study Arms (3)
Control group
NO INTERVENTIONNot intervention
Rehabilitation
EXPERIMENTAL30-60 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
EXPERIMENTAL30-60 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Granada
Granada, Granada, 18016, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Torres Sánchez, PhD
Universidad de Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT, PhD, Principal Investigator
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 7, 2025
Study Start
February 3, 2025
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
January 26, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share