Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Lower Limb Strength: 5 times Sit-to-Stand Test
研究概览
简要总结
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over).
详细描述
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over). The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in both ambulatory and hospitalized post-COVID-19 syndrome patients. The main novelty of this trial compared to other exercise-based interventions is the development and proof of concept of a progressively, levelled exercise regime for people with physical activity intolerance and fatigue symptoms.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People over 18 years of age.
- •Persistent symptoms of COVID >3 months of duration since infection.
- •Have no medical contraindications incompatible with the practice of exercise.
- •Do not meet the general 2020 recommendations for physical activity established by the World Health Organization2 (i.e., at least 150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week).
- •Provide signed informed consent.
排除标准
- •Presence of uncontrolled serious medical illness.
- •Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.
结局指标
主要结局
Change in Lower Limb Strength: 5 times Sit-to-Stand Test
时间窗: Baseline to 8 weeks
Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.
Chance in upper limbs strength: Arm Curl Biceps
时间窗: Baseline to 8 weeks
The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.
Change in pulmonary function: Inspiratory and Expiratory Pressures
时间窗: Baseline to 8 weeks
The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction. MIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient. Procedures: * MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s. * MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.
Change in cardiovascular fitness: 6-Minute Walk Test
时间窗: Baseline to 8 weeks
Number of meters that can be walked in 6 min around 30 m track.
Change in Lower Limb Strength: 30 s Sit-to-Stand test
时间窗: Baseline to 8 weeks
The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s
Change in Handgrip Strength
时间窗: Baseline to 8 weeks
Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.
Change in Balance: Flamingo Balance Test
时间窗: Baseline to 8 weeks
Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)
Change in walking speed: Brisk Walking Test
时间窗: Baseline to 8 weeks
Number of seconds required to walk 30 m.
Change in pulmonary function: Peak flow Test
时间窗: Baseline to 8 weeks
Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration. First, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.
次要结局
- Change in Quality of Life-SF-36(Baseline to 8 weeks)
- Change in The International Physical Activity Questionnaire (IPAQ)(Baseline to 8 weeks)
- Change in the Insommia Severity Index (ISI)(Baseline to 8 weeks)
- Change in Modified Medical Research Council dyspnea scale (mMRC)(Baseline to 8 weeks)
- Change in Modified Fatigue Impact Scale (MFIS)(Baseline to 8 weeks)
- Body Composition(Baseline to 8 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS)(Baseline to 8 weeks)
- Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)(Baseline to 8 weeks)
研究者
Lucia Sagarra
PhD
Universidad San Jorge