Tailored Exercise Training Study Among Adults With HFpEF
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Peak Exercise Oxygen Uptake (VO2peak)
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
详细描述
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare the effects of four different lifestyle interventions on exercise capacity.
The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.
In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.
The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>= 18 yrs
- •LVEF (Left Ventricular Ejection Fraction) >= 50%
- •History of HFpEF or at risk of HFpEF
- •HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- •NT-proBNP >360 pg/mL
- •Risk of HFpEF based on:-
- •>2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- •SPPB < 10 or VO2<60th percentile
- •BMI >=28 (for randomization in phase II)
- •Able to use cell phone and mobile application
排除标准
- •Hospitalization 1 month prior to baseline visit
- •History of recurrent falls
- •eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
- •Active changes in HF therapies over 2 weeks prior to baseline visit
- •Inability participate in exercise training therapy
- •Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- •Severe left side valvular heart disease
- •End stage pulmonary disease, requiring continuous supplemental oxygen
- •Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- •Unstable weight defined by >5% change in body weight in last 30 days before first study visit.
研究组 & 干预措施
Moderate-intensity continuous training (MCT)
Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach
干预措施: Moderate-intensity continuous training (MCT) (Behavioral)
Moderate-intensity continuous training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss
干预措施: Moderate-intensity continuous training (MCT) (Behavioral)
Moderate-intensity continuous training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss
干预措施: Weight loss (Drug)
Moderate-intensity continuous training + resistance training
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos
干预措施: Moderate-intensity continuous training (MCT) (Behavioral)
Moderate-intensity continuous training + resistance training
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos
干预措施: Resistance training (Behavioral)
Moderate-intensity continuous training + resistance training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss
干预措施: Moderate-intensity continuous training (MCT) (Behavioral)
Moderate-intensity continuous training + resistance training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss
干预措施: Resistance training (Behavioral)
Moderate-intensity continuous training + resistance training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss
干预措施: Weight loss (Drug)
结局指标
主要结局
Peak Exercise Oxygen Uptake (VO2peak)
时间窗: Baseline, 3months, 6months, and 9months
VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
Short Physical Performance Battery (SPPB)
时间窗: Baseline, 3months, 6months, and 9months
SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best.
次要结局
- Left ventricular global longitudinal strain (LV GLS)(Baseline, 3months, 6months, and 9months)
- Visceral Adiposity Deposits(Baseline, 3months, 6months, and 9months)
- GAD 7 score(Baseline, 3months, 6months, and 9months)
- Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)(Baseline, 3months, 6months, and 9months)
- 6 Minute Walk Distance (6MWD)(Baseline, 3months, 6months, and 9months)
- General Quality of Life - EQ-5D-5L(Baseline, 3months, 6months, and 9months)
- Thirty Second Chair Test(Baseline, 3months, 6months, and 9months)
- Fried Frailty Phenotype(Baseline, 3months, 6months, and 9months)
- Resting cardiac output(Baseline, 3months, 6months, and 9months)
- Exercise cardiac output(Baseline, 3months, 6months, and 9months)
- Intramyocellular fat(Baseline, 3months, 6months, and 9months)
- Intermuscular Adipose Tissue (IMAT)(Baseline, 3months, 6months, and 9months)
- Subcutaneous adiposity deposits(Baseline, 3months, 6months, and 9months)
- Pericardial Adiposity Deposits(Baseline, 3months, 6months, and 9months)
- Lower Body Adiposity Deposits(Baseline, 3months, 6months, and 9months)
- E/e': Ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e')(Baseline, 3months, 6months, and 9months)
- Left atrial reservoir strain(Baseline, 3months, 6months, and 9months)
- PHQ 9 score(Baseline, 3months, 6months, and 9months)
- NT-proBNP(Baseline, 3months, 6months, and 9months)
- High-sensitivity troponin I(Baseline, 3months, 6months, and 9months)
研究者
Ambarish Pandey
Associate Professor of Medicine
University of Texas Southwestern Medical Center