3-Month Home-based Training With Whole Body Vibration Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Peak Oxygen consumption
研究概览
简要总结
In order to evaluate Long-term effects of whole Body Vibration (wbv) in patients with HFpEF patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not performing the exercises on the wbv-device but on the floor.
详细描述
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion criteria
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training according to protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable (≥ 2 months) symptomatic heart failure with preserved ejection fraction
- •elevated NTproBNP (>= 125 ng/l)
- •NYHA-WHO/FC II or III
- •peakVO2 <25 mL/kg/min
- •LVEF ≥50%
- •E/e' >15 or 15 ≥E/e' >8 and one of the following:
- •NT-proBNP >220 ng/L ar atrial fibrillation
- •age ≥18 years
- •symptoms and heart insufficiency medication according to current guidelines and stable for at least 4 weeks
- •general mental and physical ability to perform the study
- •ability to understand and sign informed consent of the study
排除标准
- •non cardial origin of symptoms similiar to heart insufficiency
- •normal NTproBNP (< 125 ng/l)
- •relevant chronic obstructive lungdisease ≥ GOLD Stadium III
- •significant anemia (hemoglobin < 11 mg/dl)
- •relevant renal insuffciency (eGFR <30 mL/min/1.73 m2 indexed to BSA)
- •significant peripheral artery disease (Fontaine ≥ IIb)
- •muscolosclettal disease compromising ability to exercise
- •specific cardiomyopathy (e.g.. amyloidosis)
- •hemodynamic relevant, not repaired valvular diseases
- •relevant coronary artery disease (angina pectoris ≥ CCS II or positive functional test, myocardial infarction or CABG within last 3 months)
- •unability to perform exercises (mental, physical) or unability to give infromation requested (diary, quality of life)
- •uncontrolled arterial hypertension (≥140/90 mmHg or ≥160/100 mmHg with 3 antihypertensive substances) or resting heart rate ≥ 100 b.p.m.)
- •unabilty to perform training within time planned (planned vacation)
- •Rehabilitation program or planned new training program 2 months before screeninig or within the studyphase
- •pregnancy
- •acute thrombosis (within the last 3 months)
- •Implants in hib, knee or spine (TEP)
- •new fracture (within 3 months)
- •not feasable to perform trianing (NYHA IV, immobility)
研究组 & 干预措施
Group 1 WBV - training with wbv
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
干预措施: Group 1 GALILEO WBV (Device)
Group 1 WBV - training with wbv
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
干预措施: Group 2 Control (Other)
Group 2 Control - training without WBV
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
干预措施: Group 1 GALILEO WBV (Device)
Group 2 Control - training without WBV
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera
Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).
Introduction Week -1(-7d-d1): All subjects will receive introduction in their training
Month 1:
Day 1: From this day subjects are supposed to start their training accoridng to protocol
Day 2: Telephone Visit
Day 5: Telephone Visit
Day 7: Telephone Visit
Day 10: Telephone Visit
Day 13: Telephone Visit
Day 20: Telephone Visit
Day 27: Telephone Visit
Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training
Month 2:
Week 5, Day 34:
Week 6, Day 41:
Week 7, Day 48:
Week 8, Day 55:
Month 3:
Week 9, Day 62:
Week 10, Day 69:
Week 11, Day 76:
Week 12, Day 83: Final Visit
干预措施: Group 2 Control (Other)
结局指标
主要结局
Change in Peak Oxygen consumption
时间窗: 3 months
次要结局
未报告次要终点
研究者
Felix Gerhardt
Felix Gerhardt, MD
Klinikum der Universität Köln