Effects of a Physical Training Program Using a Mobile App on the Functionality and Cardiovascular Function of Individuals With Post-covid-19 Syndrome: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in Post-Covid Functional Scale at 12 weeks
研究概览
简要总结
The aim of this study is to assess the effect of a physical exercise program via a mobile application on functional parameters in individuals with post-COVID-19 syndrome. This is a clinical trial involving 60 individuals with post-COVID syndrome who will be randomly assigned to either a control group (physical activity guideline) or an experimental group (app-based training).
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)
盲法说明
Outcomes assessor will be blinded for the group of the subjects
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
- •Laboratory diagnosis of COVID-19
- •Fatigue ≥ 8 points on the Chalder Scale and/or dyspnea 2-4 on the Modified Medical Research Council
- •Have access to a smartphone
- •Have no contraindications for exercise practice
- •Have ability to sit and stand and maintain balance while standing
- •Have preserved cognitive function
- •Have no risk of falls according to the Morse Fall Scale
排除标准
- 未提供
研究组 & 干预措施
Exercise intervention
The subjects randomized to this group will perform three app-based training sessions per week for 12 weeks, each session lasting a maximum of 40 minutes.
干预措施: Exercise (Behavioral)
Control intervention
This group will receive a booklet with exercise instructions, and will be recommended the same frequency and duration of exercise as the experimental group
干预措施: Control (Behavioral)
结局指标
主要结局
Change from baseline in Post-Covid Functional Scale at 12 weeks
时间窗: Baseline and 12 weeks
The Post-COVID-19 Functional Status Scale assesses limitations following SARS-CoV-2 infection, measured as a score
Change from baseline in sit and stand test at 12 weeks
时间窗: Baseline and 12 weeks
The test consists in rising from a chair as many times as possible within 30 seconds, measured in number of repetitions
Change from baseline in 6 min-walk test distance at 12 weeks
时间窗: Baseline and 12 weeks
The 6-minute walk test performed in a 30-meter corridor, measured in meters
Change from baseline in Glittre test at 12 weeks
时间窗: Baseline and 12 weeks
The test consists in rise from a chair, carry a weighted backpack, walk 10 meters, climb stairs, move objects between shelves (1 kg each), and return. They perform tasks sequentially, transferring items up and down shelves. The route is retraced, ending by sitting back in the initial chair, measured in seconds
次要结局
- Change from baseline in Patient Functional Scale at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Motor Evoked Potential at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Modified Medical Research Dyspnea Scale at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Chalder Physical Fatigue Scale at 12 weeks(Baseline and 12 weeks)
- Change from baseline in De Paul Symptom Questionnaire at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Quality of Life at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Frailty and Sarcopenia at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Anxiety and Depressive Symptoms at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Pain at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Movement Behavior at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Barriers to Physical activity at 12 weeks(Baseline and 12 weeks)
- Post assessment of Exercise Adherence Assessment Scale(12 weeks)
- Change from baseline in Blood Pressure at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Cardiac Autonomic Modulation at 12 weeks(Baseline and 12 weeks)
- Change from baseline in Blood Flow and Flow-mediated Dilation at 12 weeks(Baseline and 12 weeks)
- Change in Spirometry parameters at 12 weeks(Baseline and 12 weeks)
研究者
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho