Prospective Aerobic Reconditioning Intervention Study (PARIS)

February 12, 2019 updated by: Wake Forest University

Exercise Conditioning in Elderly Patients With Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak exercise capacity
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1993

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.A.R.I.S. I and II
  • R01AG018915 (U.S. NIH Grant/Contract)
  • R01AG012257 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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