Early Rehabilitation, Function and Energy Efficiency After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 6MWT distance
研究概览
简要总结
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery. Secondary objectives assess baseline levels and changes post-rehabilitation in:
- Motor performance and energy efficiency during activities of daily living (ADLs).
- Energy efficiency during walking (constant-load treadmill test).
- Muscle strength and physical performance via the Short Physical Performance Battery (SPPB) and Five-Times Sit-to-Stand Test (5STS).
- Quality of life via the EuroQol questionnaire. Study Design: this 18-month, multi-center study involves several Maugeri Centres in Italy and a total of 60 patients. Participants undergo two assessment sessions (baseline and post-rehabilitation). The prescribed rehabilitation program remains strictly within routine clinical practice and will not be altered.
Measurement Device (COSMED K5): selected tests require wearing the CE-marked COSMED K5 portable metabolic analyzer. The system comprises a face mask and a lightweight backpack housing the gas analyzer. By measuring breath-by-breath gas exchange (VO2 and VCO2) alongside heart rate, respiratory rate, and blood pressure, the device precisely quantifies physiological responses to exercise. This data will help optimize recovery tracking and inform future personalized rehabilitation protocols.
Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
- Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
- Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
- Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
- GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
- Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
- EuroQol Questionnaire: Brief self-reported quality-of-life assessment. Safety & Risk Profile: this low-intervention study poses no additional risk beyond routine cardiac rehabilitation procedures (such as transfers, postural changes, and breathing exercises).
详细描述
Rationale The importance of cardiac rehabilitation (CR) following major cardiac surgery lies in its ability to reduce mortality and rehospitalization rates and to improve quality of life through a multidisciplinary approach that includes supervised exercise, education, psychological support, and optimization of medical therapy. The European Society of Cardiology, the American College of Cardiology, and the American Heart Association strongly recommend that all patients undergoing coronary revascularization, valve replacement, or heart transplantation be referred to a structured CR program. In Italy, patients undergoing major cardiac surgery frequently enter a CR program immediately after surgery to improve physical performance, promote the recovery of activities of daily living (ADLs), and achieve clinical and therapeutic stabilization. However, this intervention remains under-investigated in the literature: normative data regarding functional status during the post-operative phase, the optimal rehabilitation setting, and expected functional improvements are not widely available. Evaluating post-major cardiac surgery patients using field tests (such as the Six-Minute Walk Test [6MWT] and the Glittre ADL-Test) within a CR setting provides an objective, precise, and dynamic measure of functional capacity and cardiorespiratory response during the early stages of post-operative recovery. Using the COSMED K5 portable metabolic analyzer during post-cardiac surgery CR in patients undergoing major procedures (coronary artery bypass grafting, valve replacement) could enhance the detection of clinically meaningful changes in metabolic and functional parameters and enable a more accurate risk stratification. The COSMED K5 is a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. It offers high reliability and allows researchers to compare the metabolic impact of different exercise modalities. Indeed, this wearable device allows patient monitoring during walking, functional testing, or ADLs. In CR following cardiac surgery, the role of the COSMED K5 is to provide objective measurements of functional capacity and physiological responses to exercise, quantifying physical performance improvements to optimize the safety and efficacy of the rehabilitation intervention.
Objectives
Primary Objective:
The primary objective of this study is to assess exercise capacity at the beginning and end of a specialized inpatient or outpatient rehabilitation program in patients who have recently undergone major cardiac surgery.
Secondary Objectives:
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patients admitted to the Cardiac Rehabilitation Unit at each participating Maugeri Institute who meet all of the following criteria may be enrolled consecutively:
- Major cardiac surgery (coronary artery bypass grafting, valve surgery, or combined cardiac surgery) as the index event for the current cardiac rehabilitation episode;
- Signed informed consent;
- Participation in a complete, structured cardiac rehabilitation program (inpatient or outpatient);
- Age greater than 18 and less than 85 years (patients who have not reached their 86th birthday at the time of signing the informed consent form are considered eligible);
- Ability to ambulate independently.
排除标准
- Refusal to participate, including withdrawal of previously given consent;
- Concomitant acute neurological and/or orthopedic conditions that affect, impair, or alter walking ability;
- Overt cognitive impairment (severe impairment assessed via the Short Portable Mental Status Questionnaire [SPMSQ]) and/or diagnosed psychiatric disorders or psychiatric pharmacological treatment;
- Clinical instability and/or medical contraindications (hemodynamic instability: SBP <90 mmHg or >170 mmHg; DBP >100 mmHg; HR <40 bpm or HR >130 bpm; SpO₂ <90%);
- Diagnosed chronic obstructive and/or restrictive respiratory diseases currently under medical treatment.
研究组 & 干预措施
Intervantional arm
Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
- Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
- Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
- Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
- GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
- Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
- EuroQol Questionnaire: Brief self-reported quality-of-life assessment.
干预措施: Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. (Diagnostic Test)
结局指标
主要结局
6MWT distance
时间窗: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Change from baseline in Six-Minute Walk Test (6MWT) distance, measured in metres, at the end of the standard rehabilitation protocol within post-major cardiac surgery Cardiac Rehabilitation.
次要结局
- GLITTRE-ADL test(From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients))
- Constant-load treadmill test(From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients))
- Interval cycle ergometer exercise test(From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients))
- Short Physical Performance Battery Score(From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients))
- EuroQol Score(From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients))
研究者
研究点 (3)
标识符
- NCT 编号
- NCT07843316
- 其他研究编号
- CE185/2026 K5-POSTCCH
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否