Prevalence of Altered Pulmonary Function Post-infection by COVID-19 and Impact of Participation in a Pilot Program of Comprehensive Rehabilitation in the Short and Medium-term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Six minute walk distance
研究概览
简要总结
Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.
详细描述
In Peru, almost one million persons have survived COVID-19 and initial reports indicate that could exist long-term health damage. This study aims to assess the efficacy of a 6-week rehabilitation program following hospital discharge for patients who had severe COVID-19. The program includes 12 sessions of home-based respiratory therapy that the patient will carry out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a psychologist.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Be discharged from hospitalization with a COVID-19 confirmed diagnosis
- •Be able of understanding study procedures
- •Be able to give informed consent
- •Required oxygen flow greater than 6lt/min or through a high flow device at any time during hospitalization
- •Have been evaluated by the rehabilitation service at least once during the hospitalization
排除标准
- •Contraindications to six-minute walk test
- •Contraindications to spirometry
- •Complications during the baseline six-minute walk test
- •Have neurological pathology, neuropathy, limb dysfunction, or other underlying physical disability that makes physical exercise impossible
- •Be pregnant or breastfeeding
- •Do not have access to the Internet or a telephone line
- •Have previous lung diseases like asthma, COPD, fibrosis, or tuberculosis
- •Moderate or severe heart disease (Grade III or IV, New York Heart Association)
- •Have had another severe disease in the last six months
- •Severe depression or suicidal intention
- •Be taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition
- •Have cognitive impairment or sensory disturbance
研究组 & 干预措施
Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support
Participants in the intervention arm will receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital.
Additionally, these participants will receive the intervention program that involves home-based respiratory physiotherapy and telephone-based psychological support for 6 weeks.
干预措施: Respiratory and psychological rehabilitation (Other)
Control
Participants in the control arm will only receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital.
结局指标
主要结局
Six minute walk distance
时间窗: Change from baseline measure at hospital discharge to week 7 and 12
Distance walked during 6-minutes (meters)
次要结局
- Forced expiratory volume in the first second(Change from baseline measure at hospital discharge to week 7 and 12)
- Forced Vital Capacity(Change from baseline measure at hospital discharge to week 7 and 12)
- Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)(Change from baseline measure at hospital discharge to week 7 and 12)
- Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.(Change from baseline measure at hospital discharge to week 7 and 12)
- Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)(Change from baseline measure at hospital discharge to week 7 and 12)