Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Upper limb strength change
研究概览
简要总结
Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.
The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.
Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.
Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.
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
- •Age 18 years or older.
- •Have been diagnosed COVID-19 positive at the time of hospital admission.
- •Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
- •Be able to read the informed consent form and understand the objectives and conduct of the study.
排除标准
- •Diagnosed neurological or psychiatric disease.
- •Contraindications to physical exercise.
- •Failure to give informed consent for the study.
- •Unavailability to perform the ET program twice a week.
研究组 & 干预措施
Therapeutic Exercise group
The study participants corresponding to the Therapeutic Exercise (ET) intervention group will follow the prescriptions given to them by their primary care physician. In addition, and as the main part of the intervention, they will undergo a six-week ET program with two sessions per week, for a total of 12 sessions. Full participation in 10 sessions will be necessary to be included in the ET group during the statistical analysis. Each session will be one hour long. The sessions will be given and supervised by a physiotherapist expert in therapeutic exercise prescription through the online modality.
干预措施: Therapeutic Exercise (Other)
Control group
Study participants in the control group will follow the prescriptions given to them by their primary care physician and will receive a weekly call to assess their recovery. At the end of the study follow-up, when their participation in the study as a control group ends, participants in this group will be offered to participate in the structured ET program to be carried out by the ET group. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of the research.
结局指标
主要结局
Upper limb strength change
时间窗: Change from Baseline upper limb strength at 6 weeks
handgrip strength test
次要结局
- Walking speed change(Change from Baseline walking speed at 6 weeks)
- Physical Performance change(Change from Baseline physical performance at 6 weeks)
- lower limb strength change(Change from Baseline lower limb strength at 6 weeks)
- Fraility change(Change from Baseline fraility at 6 weeks)
研究者
Albert Pérez Bellmunt
Doctor
Universitat Internacional de Catalunya