Prospective Aerobic Reconditioning Intervention Study
Completed · Not applicable
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT01113840
- Run by
- Wake Forest University
- People needed
- 201
- Starts
- 1993-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2019-02-15
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than or equal to 60 years of age
- Symptoms of congestive heart failure
- Able to understand and give informed consent
You may not qualify if…
- 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
- Chronic obstructive pulmonary disease on therapy that limits exercise duration
- Uncontrolled diabetes mellitus
- Active treatment for cancer or other noncardiovascular conditions with life expectancy less than three years
- Anemia "10 gms Hb)
- Renal insufficiency (cr >2.5 mg/dl)
- Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder
- Dementia - MMSE \~24 "22 for \~8th grade education)
- Lack of an acoustic window sufficient to allow definition of endocardial borders on the screening echocardiogram.
- Plans to leave area or be admitted to a nursing home within 2 years.
- Inability to walk at least 420 feet in 6 minutes without a cane or other assistive device.
- Inability to exercise at or near home.
- At the discretion of the clinical staff, it is believed that the participant cannot or will not complete the protocol because of frailty, illness, or other reason.
- Participation in a regular exercise regimen more than one time per week for at least twenty minutes per session; including but not limited to walking, swimming, weight lifting, golfing, or taking an exercise class.
- Inability to ambulate without cane or other assistive device during biomechanics testing or treadmill.
- Inability to attend at least fourteen weeks of the facility-based intervention
Where it is running
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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