Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in a Setting of Inpatient Cardiac Rehabilitation and Home Training Program in Elderly Patients With Different Frailty Stages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Autonomic nervous function by Heart Rate Fragmentation (HRR)
研究概览
简要总结
To develop and investigate an unobtrusive technology for long-term monitoring of autonomic nervous system (ANS) function's response to daily physical stressors and exercise training for elderly patients with different frailty stages.
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)
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
- •Patients admitted to CR after open heart surgery.
- •Age 65 years and older.
- •6-minute walk distance (6-MWD) ≥150 meters.
- •Patient's agreement to participate in the study.
- •Edomonton Frailty Scale score 5 points and more
排除标准
- •Cardiac devices (due to artificially altered heart rate series)
- •Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- •Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.
结局指标
主要结局
Autonomic nervous function by Heart Rate Fragmentation (HRR)
时间窗: 12 weeks
HRF measured by RR interval indexes:percentage of inflection points (PIP), inverse of the average length of the acceleration/deceleration segments (IALS), percentage of short segments (PAS), percentage of alternation segments (PSS).
Autonomic nervous function by Heart Rate Recovery (HRR)
时间窗: 12 weeks
HRR (beats per minute) is a difference of the maximal HR obtained during stress testing and HR during the recovery period: HR30-360 the decay of heart rate from 30 to 360 s after the recovery onset.
次要结局
- Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)(12 weeks)
- Cardiopulmonary exercise capacity by maximal load (maxWatt)(12 weeks)
- Functional capacity by six minutes walking test (6MWT)(12 weeks)
- Physical performance by Timed up and Go test (TUG)(12 weeks)
- Gait evaluation by step time(12 weeks)
- Frailty level by Edmonton frailty scale (EFS)(12 weeks)
研究者
Eglė Tamulevičiūtė-Prascienė
Head of a Rehabilitation department, Lithuanian University of Health Sciences hospital Kaunas Clinics, Kulautuva rehabilitation hospital
Lithuanian University of Health Sciences