Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in Post-Intensive Care Syndrome: Clinical and Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Peripheral muscle function I
研究概览
简要总结
Survivors of prolonged critical illness may develop post-intensive care syndrome, with reduced respiratory and peripheral muscle function and exercise capacity. This trial compared a home-based rehabilitation programme delivered through a self-explanatory workbook with weekly telephone monitoring against centre-based supervised rehabilitation.
The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and functional status.
详细描述
This is a randomized, controlled, assessor-blind treatment trial with a 1:1 allocation ratio.
Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient rehabilitation center. The participants will be adults (≥18 years and ≤ 65 years), who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged after, between three and six months from hospital discharge between 2023 to 2025.
Intervention and comparison:
This study will be divided into three groups: control group(standard rehabilitation), face-to-face home intervention group. Both groups will be evaluated before and after the study period. Physical functions and functional capacity will be evaluated.
After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation sequence was generated before the start of enrolment. The assessor who performed the baseline clinical and functional evaluation was unaware of the arm to which the participant had been allocated, because allocation was disclosed only after that evaluation had been completed and recorded. Participants then followed the allocation already generated. The physiotherapists who delivered the rehabilitation sessions applied the assigned protocol and were not informed of the outcomes under investigation or of the hypothesis of the trial, so that their conduct of the sessions could not be oriented towards any particular outcome; they could not be blinded to the modality itself, since the two programmes are delivered in different settings. The assessor who performed the 12-week evaluation was unaware of the arm to which the participant had been allocated. Participants could not be blinded to the modality they received.
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
- •Patients who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged after more than seven days of intensive care, between three and six months from hospital discharge;
- •Both sexes;
- •Over 18 years old and under 65 years old.
排除标准
- •Need for supplemental home oxygen;
- •Motor or neurological or cognitive alteration that contraindicates the participation in the cardiopulmonary rehabilitation program.
- •Persistence of clinical signs of deep vein thrombosis
结局指标
主要结局
Peripheral muscle function I
时间窗: 12 weeks
Will be assessed using the Palm Grip Dynamometry
Peripheral muscle function II
时间窗: 12 weeks
Will be assessed using the Quadriceps Peak Load Test
Peripheral muscle function III
时间窗: 12 weeks
Will be assessed using the Quadriceps Muscle Endurance Test.
Daily living activity
时间窗: 12 weeks
It will be evaluated by the Post-COVID Function Scale(PCFS)
Functional Capacity
时间窗: 12 weeks
By 6MWD following the ERS/ATS field walking test
Respiratory muscle function (MIP)
时间窗: 12 weeks
MIP will be measure according to the ATS/ERS statement on respiratory muscle testing
Peripheral muscle function
时间窗: 12 weeks
Quadriceps strength will be assessed by a one-repetition-maximum (1-RM) test on an extension chair and quadriceps endurance will be assessed after 30 minutes of rest as the time for which a load corresponding to 40% of the 1-RM could be sustained isometrically until task failure (isometric endurance, in seconds)
次要结局
- Quality of life improvement(12 weeks)
研究者
Ana Carolina Sebastião da Silva
Master's Degree
Centro Universitário Augusto Motta