Rehabilitation of Fatigue in Patients With Post-COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Perceived Fatigue
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Not intervention
Rehabilitation
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.
干预措施: Rehabilitation (Behavioral)
Virtual reality based rehabilitation
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.
干预措施: Virtual reality based rehabilitation (Behavioral)
结局指标
主要结局
Perceived Fatigue
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Health-related Quality of life(Through study completion, an average of 1 year)
- Functional status: Post-COVID-19 Functional Status (PCFS)(Through study completion, an average of 1 year)
- Functional status: Patient-Specific Functional Scale (PSFS)(Through study completion, an average of 1 year)
- 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)
- Pain intensity(Through study completion, an average of 1 year)
- Psychological status(Through study completion, an average of 1 year)
- Sleep quality(Through study completion, an average of 1 year)
- Frailty: Clinical Frailty Scale (CFS)(Through study completion, an average of 1 year)
- Frailty: FRAIL Scale(Through study completion, an average of 1 year)
- Physical activity(Through study completion, an average of 1 year)
- Exercise capacity: Short Physical Performance Battery (SPPB)(Through study completion, an average of 1 year)
- Exercise capacity: 2-Minute Walk Test(Through study completion, an average of 1 year)
- Exercise capacity: One-Legged Stand Test(Through study completion, an average of 1 year)
- Exercise capacity: Arm Curl Test(Through study completion, an average of 1 year)
- Strength(Through study completion, an average of 1 year)
- Motivation for Treatment(Through study completion, an average of 1 year)
- Treatment-Generated Motivation(Through study completion, an average of 1 year)
- Satisfaction with the Intervention(Through study completion, an average of 1 year)
- Overall Perceived Effort(Through study completion, an average of 1 year)
- Adherence(Through study completion, an average of 1 year)
研究者
Irene Torres Sánchez
PT, PhD, Principal Investigator
Universidad de Granada