Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood Biomarkers
研究概览
简要总结
The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).
详细描述
In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group [CTL] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).
Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and
排除标准
- •and that participation in exercise testing and resistance exercise training is safe.
- •Inclusion Criteria, includes:
- •Clinical diagnosis of HFpEF.
- •Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
- •New York Heart Association class I-III.
- •Ejection fraction ≥40%.
- •Current non-smokers with <15 pack year history.
- •Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).
- •Exclusion Criteria, includes:
- •Patient refusal to participate.
- •Significant orthopedic or neuromuscular limitations
- •Significant cognitive impairment
- •Hemoglobin < 7.0 g/d.
研究组 & 干预措施
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Resistance Exercise Training (Other)
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: DEXA bone scan (Radiation)
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Cardiopulmonary Max Exercise Test (Other)
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Quality of Life Questionnaire (Other)
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Submaximal Exercise Test (Other)
Resistance Exercise Training
Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Blood Draw (Other)
Standard Care
No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: DEXA bone scan (Radiation)
Standard Care
No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Cardiopulmonary Max Exercise Test (Other)
Standard Care
No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Quality of Life Questionnaire (Other)
Standard Care
No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Submaximal Exercise Test (Other)
Standard Care
No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.
干预措施: Blood Draw (Other)
结局指标
主要结局
Blood Biomarkers
时间窗: 12 weeks
Blood draw
Bone density and strength
时间窗: 12 weeks
DEXA scan
Cardiopulmonary Function
时间窗: 12 weeks
Cardiopulmonary bike exercise
Quality of Life
时间窗: 12 weeks
Questionnaire
次要结局
未报告次要终点
研究者
Thomas P. Olson, M.S., Ph.D.
Principal Investigator
Mayo Clinic