Clinical trial NCT06814379: Rehabilitation of Fatigue in Patients with Post-COVID-19 Syndrome
Official title: Rehabilitation of Fatigue in Patients with Post-COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: COVID-19
post-COVID-19 syndrome
fatigue
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Multidimensional Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Fatigue Severity
timeFrame: Through study completion, an average of 1 year
measure: Fatigue Impact
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: COVID-19 information
timeFrame: Through study completion, an average of 1 year
measure: Comorbidities
timeFrame: Through study completion, an average of 1 year
measure: Dyspnea. The Borg Modified Scale
timeFrame: Through study completion, an average of 1 year
measure: Dyspnea. Dyspnea-12
timeFrame: Through study completion, an average of 1 year
measure: Dyspnea. Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Through study completion, an average of 1 year
measure: Pain intensity
timeFrame: Through study completion, an average of 1 year
measure: Psychological status
timeFrame: Through study completion, an average of 1 year
measure: Sleep quality
timeFrame: Through study completion, an average of 1 year
measure: Health-related Quality of life
timeFrame: Through study completion, an average of 1 year
measure: Functional status: Post-COVID-19 Functional Status (PCFS)
timeFrame: Through study completion, an average of 1 year
measure: Functional status: Patient-Specific Functional Scale (PSFS)
timeFrame: Through study completion, an average of 1 year
measure: Frailty: Clinical Frailty Scale (CFS)
timeFrame: Through study completion, an average of 1 year
measure: Frailty: FRAIL Scale
timeFrame: Through study completion, an average of 1 year
measure: Physical activity
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity: Short Physical Performance Battery (SPPB)
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity: 2-Minute Walk Test
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity: One-Legged Stand Test
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity: Arm Curl Test
timeFrame: Through study completion, an average of 1 year
measure: Strength
timeFrame: Through study completion, an average of 1 year
measure: Motivation for Treatment
timeFrame: Through study completion, an average of 1 year
measure: Treatment-Generated Motivation
timeFrame: Through study completion, an average of 1 year
measure: Satisfaction with the Intervention
timeFrame: Through study completion, an average of 1 year
measure: Overall Perceived Effort
timeFrame: Through study completion, an average of 1 year
measure: Adherence
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Granada
name: Irene Torres Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: