Early REmote Rehabilitation to Improve Health of the Elderly After CARDiac Surgery. (RECARD Trial). A Bi-center, Prospective, Randomized, Open-label, Blinded Evaluation (PROBE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU
研究概览
简要总结
An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery.
Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care.
Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery.
All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies.
The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function.
详细描述
Hypotheses:
Primary: Early mobile health intervention at home supplemented by weekly calls from a physiotherapist after cardiac surgery improves functional outcomes, exercise tolerance, and quality of life in older patients.
Secondary:
- Cardiac surgery increases the prevalence and extent of sarcopenia in the elderly which can be mitigated by early mobile health intervention
- Sarcopenia on Chest Computed Tomography (CCT) is strongly correlated to functional outcome and quality of life following cardiac surgery
- Early mobile health intervention is feasible and cost-effective
Design:
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
Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Scheduled first-time heart surgery through median sternotomy
- •Male or female, aged ≥ 65 years (The age criterion implies the exclusion of women of childbearing potential)
排除标准
- •Medical conditions requiring referral to specialized rehabilitation (e.g., severe heart or lung failure, need for blood pressure monitoring during exercise)
- •Emergent procedure
- •Anticipated inability to perform intervention, study assessment procedures, or follow-up
- •Participation in any other interventional clinical that may interfere with the outcome measures
研究组 & 干预措施
Control
Standard care consists of physiotherapy group education of about 10-15 minutes regarding mobilization, respiratory therapy, and sternal precautions after surgery. After surgery, phase I in-hospital rehabilitation consists of respiratory therapy, mobilization from supine and sitting position, and walking down a corridor. Prior to discharge, all patients are encouraged to undertake daily walks and resume activities of daily living, and engage in recommended moderate physical activity (Borg's scale 12-14). All patients are referred to CR in their municipality.
Early mobile health intervention
ICURA app and sensor-based technology, individualized training plan, and weekly calls from a physiotherapist in addition to standard care
干预措施: Early mobile health intervention supplemented by weekly calls from a physiotherapist (Device)
结局指标
主要结局
Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU
时间窗: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Recording of the number of stands a person can complete from a chair without arms in 30 seconds
次要结局
- Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Change (Δ) in EuroQol-score baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU(6 weeks (+/- 4 days) after discharge)
- Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Change (Δ) in WHO-5-score baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Change (Δ) in ASS-2-score baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Change (Δ) in MDI-2-score baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Change in skeletal muscle mass baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Cost-effectiveness analysis(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery)
- Changes in markers of inflammation through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Assessment of muscle quality through obtainment of biopsies of the pectoralis major muscle at the surgery(At surgery)
- Changes in markers of nutrition through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Changes in markers of kidney function through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Changes in markers of liver function through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
- Changes in markers of hormone levels through blood samples baseline vs. 6-week FU(1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge)
研究者
Ivy susanne Modrau, MD
Dr. Med., Consultant Cardiac Surgon, Associate Professor
Aarhus University Hospital Skejby