A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Exercise self-efficacy scales Scores
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.
详细描述
The hypothesis is that enhancing Supervised exercise training (SET) with a group-mediated behavioral approach and remote activity-monitoring will enable more robust behavioral changes in physical activity at lower cost. To test this hypothesis, the study will recruit patients with Heart failure with preserved ejection fraction (HFpEF) and assign to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations / Prior HF hospitalization / Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography & natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score
- •Left ventricular ejection fraction ≥ 50%
- •New York Heart Association (NYHA) functional class II-IV
- •Age ≥ 55 years old
排除标准
- •Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment
- •Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment
- •Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment
- •Uncontrolled hypertension
- •Recent or debilitating stroke
- •Severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
- •Hemoglobin (Hgb) < 9.5 g/dL males and < 9 g/dL females within 30 days prior to enrollment
- •Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list
- •Significant, unrepaired cardiac valvular disease
- •A non-cardiac medical condition with an estimated life expectancy of < 12 months
- •Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
- •Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter
- •A treadmill exercise test revealing: ischemia; chest pain or leg claudication; exercise Systolic Blood Pressure > 240 mmHg, Diastolic Blood Pressure > 110 mmHg; unstable hemodynamics or rhythm; or unwilling or unable to complete adequate exercise test
- •Already engaging in regular moderate to vigorous exercise conditioning defined as >30 minutes per day, ≥twice per week consistently during the previous 6 weeks
- •Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc.
- •Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention)
研究组 & 干预措施
multi-domain behavioral, coaching, and exercise protocol
A non-randomized, single-arm, iterative refinement pilot study. The study will recruit older patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and assign them to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
干预措施: multi-domain behavioral, coaching, and exercise protocol (Behavioral)
结局指标
主要结局
Exercise self-efficacy scales Scores
时间窗: Baseline
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Exercise self-efficacy scales Scores
时间窗: Week 4
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Exercise self-efficacy scales Scores
时间窗: Week 12
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Exercise Benefits/Barriers Scale Score
时间窗: Baseline
Evaluates how participants determine benefits of and barriers to participating in exercise.
Exercise Benefits/Barriers Scale Score
时间窗: Week 4
Evaluates how participants determine benefits of and barriers to participating in exercise.
Exercise Benefits/Barriers Scale Score
时间窗: Week 12
Evaluates how participants determine benefits of and barriers to participating in exercise.
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
时间窗: Baseline
scores from 0-100, where higher scores indicate better health
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
时间窗: Week 4
scores from 0-100, where higher scores indicate better health
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
时间窗: Week 12
scores from 0-100, where higher scores indicate better health
Number of daily steps by accelerometer
时间窗: Baseline
Number of daily steps recorded for 1 week
Number of daily steps by accelerometer
时间窗: Week 4
Number of daily steps recorded for 1 week
Number of daily steps by accelerometer
时间窗: Week 12
Number of daily steps recorded for 1 week
6-minute walk distance
时间窗: Baseline
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
6-minute walk distance
时间窗: Week 4
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
6-minute walk distance
时间窗: Week 12
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
The Short Physical Performance Battery (SPPB) Score
时间窗: Baseline
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
The Short Physical Performance Battery (SPPB) Score
时间窗: Week 4
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
The Short Physical Performance Battery (SPPB) Score
时间窗: Week 12
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
Grip strength
时间窗: Baseline
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Grip strength
时间窗: Week 4
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Grip strength
时间窗: Week 12
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Cardiopulmonary Exercise Testing (CPET)
时间窗: Baseline
Evaluates how your heart, lungs, and muscles work together during physical exertion, using a treadmill or bike while monitoring breathing (mask), heart activity (ECG), and vitals (blood pressure) to diagnose causes of shortness of breath, assess heart/lung conditions like heart failure or Chronic Obstructive Pulmonary Disease (COPD), and determine exercise capacity, offering a comprehensive view of cardiovascular and respiratory fitness. Normal values typically range from 35 to 40 mL/kg/min for healthy middle-aged individuals, with variations based on age, sex, and training status.
Cardiopulmonary Exercise Testing (CPET)
时间窗: Week 12
Evaluates how your heart, lungs, and muscles work together during physical exertion, using a treadmill or bike while monitoring breathing (mask), heart activity (ECG), and vitals (blood pressure) to diagnose causes of shortness of breath, assess heart/lung conditions like heart failure or Chronic Obstructive Pulmonary Disease (COPD), and determine exercise capacity, offering a comprehensive view of cardiovascular and respiratory fitness. Normal values typically range from 35 to 40 mL/kg/min for healthy middle-aged individuals, with variations based on age, sex, and training status.
次要结局
未报告次要终点