Efficacy of Exercise-based mHealth Intervention for Patients With Post-acute COVID-19 Syndrome Based on Fatigue, Fitness, Post-exertional Dyspnea, Pain, Anxiety, Depression, Cognitive Function, and Quality of Life: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))
研究概览
简要总结
Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.
Our hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.
The achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.
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
A single-blind method will be carried out on the persons collecting and analysing the data.
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
- •Male and female patients.
- •Over 18 years of age.
- •Absence of cognitive and physical deficits that would preclude physical exercise.
- •Owner of a smartphone with Internet access.
- •Ability to understand and write in Spanish.
- •Exclusion criteria:
- •Concomitant diseases that prevent physical exercise.
- •Contraindications to physical exercise detected by physicians.
- •Participation in moderate-intensity activities (more than 30 minutes and 3 times per week) at the time of study initiation.
排除标准
- 未提供
结局指标
主要结局
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))
时间窗: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
The FSS consists of 9 items related to the interference of fatigue with specific activities and rates the perceived severity of fatigue on a 7-point scale (1 = "strongly disagree"; 7 = "strongly agree").
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)
时间窗: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Post-exertional dyspnea is assessed using the Dyspnea-12, a short questionnaire that takes into account both sensory and affective factors that may play a role in dyspnea. Each item in the questionnaire is scored from 0, if the symptom is mild, to 3, if it is severe, and the total score is the sum of the scores for all items. Six of the questions relate to sensory aspects and 6 to affective aspects of dyspnea. The total score ranges from 0 to 36, with 36 being the highest possible severity and 0 being the lowest.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)
时间窗: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
The Short Form-12 (SF-12v2) will be administered to assess quality of life. This instrument contains 12 items that allow us to calculate the profile of 8 dimensions: (physical functioning, role-physical, bodily pain, general health perception, vitality, social functioning, role-emotional, and mental health) and two global scores: the physical health (PCS-12) and the mental health (MCS-12) component summary. Each global score ranges from 0 to 100, with higher scores indicating better health.
次要结局
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Daily registry of the adherence (CovidReApp log registration and self-reported)(Daily.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
- Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))(Only CovidReApp group: Daily.)
- Baseline of sociodemographic variables(Baseline.)
- Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))(Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.)
研究者
Jose A. Moral-Munoz
Assistant Professor
University of Cadiz