Prospective Clinical Trial of Trak Tool Usage in Post-COVID-19 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Barthel index
研究概览
简要总结
The clinical trial aims to analyse the effectiveness of a physiotherapeutic exercise program delivered through the telerehabilitation tool (Trak) compared to a booklet-based rehabilitation format in post-COVID-19 patients.
This research seeks to provide insights into the acceptance of the TRAK tool in this specific population, contributing to the advancement of understanding in this field.
Participants will be assigned to either the control group, which will receive conventional rehabilitation, or the experimental group, which will undergo telerehabilitation. Both groups will undergo a 6-week physical intervention, with pre- and post-intervention evaluations.
Researchers will compare the control and experimental groups to determine if there are significant differences in the health conditions of each group.
详细描述
The study recruitment process targets individuals who have experienced COVID-19 (moderate or severe), regardless of whether they required hospital admission, and who necessitate rehabilitation post-disease and have been discharged from quarantine.
After initial screening, individuals meeting predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants to ensure ethical compliance and respect for individual autonomy.
The primary evaluation variable selected for the study is functional capacity. Additionally, secondary assessments will include measurements of muscle strength, subjective perception of exertion, heart rate, oxygen saturation, lung capacity, and adherence to treatment (only in the experimental group).
The study cohort will comprise patients randomly assigned to experimental or control groups.
Only patients in the experimental group will receive an email containing access to the TRAK platform as part of the informed consent process. Here, they will conduct their treatment. Initial and final assessments will be performed using a digital Case Report Form for the control and experimental groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that have suffered COVID-19 [COVID-19-moderate: clinical signs of pneumonia (fever, cough, dyspnea, tachypnea), but without signs of severe pneumonia, particularly oxygen saturation greater than or equal to 90% with air atmosphere; COVID-19-severe: clinical signs of pneumonia (fever, cough, dyspnea, tachypnea) plus one of the following: frequency respiratory > 30 inspirations/min; severe dyspnea; treatment oral medication.]
- •Patients with COVID-19-related muscle pain.
- •Patients with a personal device such as a tablet, smartphone, or laptop operate agilely with these devices.
- •Patients with email.
- •Signing of the informed consent.
排除标准
- •Patients with a resting heart rate higher than 110 beats per minute.
- •Patients with blood pressure less than 90/60 or over 160/
- •Patients with lower blood oxygen saturation of 90%.
- •Patients with advanced cognitive impairment.
结局指标
主要结局
Barthel index
时间窗: Baseline; up to 6 weeks
It assesses daily activities in patients with musculoskeletal or neuromuscular conditions.
次要结局
- Resting heart rate(Baseline; up to 6 weeks)
- Lung capacity(Baseline; up to 6 weeks)
- Daniels scale(Baseline; up to 6 weeks)
- Trak satisfaction questionnaire(Up to 6 weeks)
- Borg scale(Baseline; up to 6 weeks)
- Oxygen saturation(Baseline; up to 6 weeks)