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Trial record 1 of 1 for:    NCT01113840
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Prospective Aerobic Reconditioning Intervention Study (PARIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113840
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : February 15, 2019
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Exercise Behavioral: Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Conditioning in Elderly Patients With Heart Failure
Study Start Date : July 1993
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control
Control group continues with their daily activity as they were prior to randomization. Receive bi-weekly follow-up phone calls to assess health status and encourage adherence with protocol.
Behavioral: Control
Control group continues daily life as prior to randomization.

Active Comparator: Exercise
Exercise classes three times per week in a controlled, supervised environment.
Behavioral: Exercise
Exercise classes three times per week in a controlled, supervised environment.

Primary Outcome Measures :
  1. Peak exercise capacity [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113840

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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
National Institutes of Health (NIH)
National Institute on Aging (NIA)
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Principal Investigator: Dalane W Kitzman, MD Wake Forest University Health Sciences

Publications of Results:

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Responsible Party: Wake Forest University Identifier: NCT01113840     History of Changes
Other Study ID Numbers: P.A.R.I.S. I and II
R01AG012257 ( U.S. NIH Grant/Contract )
R01AG018915 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
heart failure
diastolic dysfunction

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases