Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Manual grip strength
研究概览
简要总结
The purpose of the study will be to evaluate the effect of a rehabilitation program on the improvement of patients with post-COVID-19 musculoskeletal symptoms, as well as to quantify the impact of telemedicine that evaluates the evolution of pain, functionality, and quality of life.
详细描述
A randomized clinical trial will be conducted in 100 patients with post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions. Data will be collected on the improvement of functional capacity and quality of life, in addition to assessing the evolution of musculoskeletal symptomatology, as well as pain and psychological variables. The telemedicine sessions will improve user adherence and follow-up, and the results are expected to be disseminated to the scientific community during and after the end of the study.
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
- None
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
- •Need to be post-COVID-19 patients (ICU or non-ICU)
- •Musculoskeletal symptoms
- •Be of adult age (over 18 years)
排除标准
- •Myocardial infarction
- •Uncontrolled arrhythmia
- •Recent pulmonary thromboembolism
- •Terminal illness
- •Patients undergoing lower limb unloading
- •Lower or upper limb fractures in the last three months
- •Severe pain (score greater than 7 on the VAS of 10 points)
- •Suffering from the previous pathology that causes neuromuscular weakness
- •Be younger than 18 and older than 65 years old
- •Influenced by medication that does not allow assessment of the real muscular functionality of the patient
- •Patients with cognitive impairment that would prevent them from understanding and collaborating in the performance of the rehabilitation program plus telemedicine
- •Patients with cardiorespiratory instability and uncontrolled arterial hypertension
- •Systemic illness (tumor and rheumatologic diseases)
- •Recent unrelated trauma
- •Limiting psychiatric pathology
结局指标
主要结局
Manual grip strength
时间窗: Change from base line and at the end of each of the six weeks
Grip strength will be measured in the affected hand and in the healthy hand (measuring the maximum grip strength). For this measurement, Handgrip strength averaging the result of three attempts with the dominant hand using a Baseline© model pear dynamometer
Assessment of exercise capacity
时间窗: Change from base line and at the end of each of the six weeks
Exercise capacity will be measured with a six-minute walking test (6MWT), a sub-maximal exercise test which consists of the patient walking for six minutes along a 30 - meter corridor with two cones marking the distance to be covered while being given a series of cues.
COPD Assessment Test (CAT)
时间窗: Change from base line and at the end of each of the six weeks
CAT is an eight item questionnaire to assess: cough, sputum, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep and energy scored from zero to 4 in each item, zero corresponds to the least affected and 5 to the most affected
Quality of life according to Short- Form 36 Questionnaire (SF - 36)
时间窗: Change from base line and at the end of each of the six weeks
SF - 36 is an instrument to asses health - related quality of life, this evaluates eight spheres (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) scored from zero to 100, where 100 is equivalent to no disability and zero is equivalent to maximum disability.
次要结局
- Assessment of perceived pain(Change from base line and at the end of each of the six weeks)
- Beck II (Depression)(Change from base line and at the end of each of the six weeks)
- STAI (State-Trait Anxiety)(Change from base line and at the end of each of the six weeks)
- TSK (Tampa Scale for Kinesiophobia)(Change from base line and at the end of each of the six weeks)
- Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)(Change from base line and at the end of each of the six weeks)
研究者
Eleuterio Atanasio Sánchez Romero
Principal Investigator
Universidad Europea de Madrid