The Use of Incentive Spirometry (Triflow) in Patients With Long Covid
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Peak Flow Meter
研究概览
简要总结
The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.
详细描述
Randomised controlled trial with 2 groups:Triflow and exercises (intervention) and exercises (control)
Exercises:Exercises in the bed, chair and standing with/without weights, walking, cycle ergometer, treadmill.
Triflow: 10 breaths in and 10 breaths out.
Both groups will have 1 physiotherapy session per day for 6 days per week from admission to discharge.
Sample size:The sample size is 70. We took into consideration the efficacy of completing the recruitment of patients in time. There few published studies with the use of Triflow as their primary intervention with smaller sample sizes.
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
- •Adults who were infected with COVID-19 in the last 6 months and were diagnosed with long-covid syndrome
- •Patients must be willing to give written consent for participation in the study
- •Negative rapid test for COVID-19
排除标准
- •History of diseases that do not allow exercise (e.g. unstable cardiac disease)
- •Age < 18 years of age
- •Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
- •Lack of will to do the exercises or refuse to give consent
研究组 & 干预措施
Triflow
Use of Triflow device and exercise regime
干预措施: Triflow (Other)
Control
Only exercise regime
干预措施: Control (Other)
结局指标
主要结局
Peak Flow Meter
时间窗: on discharge day
Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is
Barthel Index
时间窗: on discharge day
Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living.
Dyspnoea (Medical Research Council Dyspnoea Scale)
时间窗: on discharge day
Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is
次要结局
- Number of hospitalisation days(on discharge day)
- Muscle strength (Hand Grip)(on discharge day)
- Balance (Berg Balance)(on discharge day)
- Muscle strength and endurance (30 seconds Sit to stand)(on discharge day)
- Cardiorespiratory fitness (Six minutes walking test)(on discharge day)
- Quality of life (EQ-5D-5L)(on discharge day)
- Fatigue (Multidimensional fatigue inventory)(on discharge day)
- Timed up and Go(on discharge day)
研究者
Marina Kloni
Marina Eleni Kloni, BSc, MSc, MA
European University Cyprus