Exercise Conditioning in Elderly Patients With Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Wake Forest University
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Peak exercise capacity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is :
- To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.
- To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.
- To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.
Detailed Description
In patients over age 65, cardiovascular disease accounts for the largest percentage of deaths, hospital days, doctor visits, and overall health care expenditures. In addition, heart failure is the most common discharge diagnosis in the elderly. Heart failure can be defined as a state in which cardiac output is insufficient to meet metabolic demands. This is most frequently manifested by symptoms of fatigue and dyspnea. Inherent in this definition is that symptoms may be increased or only occur during times when metabolic demand is increased, such as during exercise. As such, exercise intolerance is a hallmark of the heart failure syndrome. Exercise intolerance correlates not only with disease severity and also with subsequent mortality. Exercise tolerance can be objectively quantified during maximal symptom limited standardized exercise protocols by analysis of exercise time, workload, METS (metabolic equivalents), and oxygen consumption (V02)' These measures have appropriately become accepted as standards for functional assessment in this disorder as well as outcome measures following therapeutic interventions in HF. P.A.R.I.S. is a randomized, attention-controlled, single-blind trial of supervised aerobic exercise training in older patients with heart failure. The primary outcome is exercise capacity and the main secondary outcome is quality of life. Mechanistic outcomes were also examined. In PARIS, which focused on cardiac mechanisms, there were HFPEF and HFREF patients studied in parallel. In PARIS-II, there were only HFPEF patients which focused on vascular mechanisms. Main outcomes have been reported (see citations below).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age greater than or equal to 60 years of age
- •Symptoms of congestive heart failure
- •Able to understand and give informed consent
Exclusion Criteria
- •Age \<60 years
- •Does not have CHF
- •Significant change in cardiac medication \<3 weeks
- •Myocardial infarction \<3 weeks
- •CABG surgery \<3 months
- •Angina pectoris not controlled during daily activity by pharmacological therapy or at \<4 METS activity
- •Sustained hypertension with systolic\> 190 and diastolic\> 110 on medications
- •Valvular heart disease as the primary etiology of CHF
- •Significant aortic stenosis
- •Stroke of \<3 months or with any physical restriction impairment that would prevent participation in exercise programs
Outcomes
Primary Outcomes
Peak exercise capacity
Time Frame: 16 weeks
Secondary Outcomes
- Quality of life(16 weeks)