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Prospective Aerobic Reconditioning Intervention Study (PARIS)

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Control

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring elderly, heart failure, exercise, diastolic dysfunction

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Exercise

Arm Description

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.

Exercise classes three times per week in a controlled, supervised environment.

Outcomes

Primary Outcome Measures

Peak exercise capacity

Secondary Outcome Measures

Quality of life

Full Information

NCT ID

NCT01113840

First Posted

April 29, 2010

Last Updated

February 12, 2019

Sponsor

Wake Forest University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01113840

Brief Title

Prospective Aerobic Reconditioning Intervention Study

Acronym

PARIS

Official Title

Exercise Conditioning in Elderly Patients With Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 1993 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

elderly, heart failure, exercise, diastolic dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Exercise

Arm Type

Active Comparator

Arm Description

Exercise classes three times per week in a controlled, supervised environment.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

Exercise classes three times per week in a controlled, supervised environment.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Control group continues daily life as prior to randomization.

Primary Outcome Measure Information:

Title

Peak exercise capacity

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Quality of life

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dalane W Kitzman, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12413374

Citation

Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50. doi: 10.1001/jama.288.17.2144.

Results Reference

result

PubMed Identifier

20852060

Citation

Kitzman DW, Brubaker PH, Morgan TM, Stewart KP, Little WC. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. 2010 Nov;3(6):659-67. doi: 10.1161/CIRCHEARTFAILURE.110.958785. Epub 2010 Sep 17.

Results Reference

result

PubMed Identifier

20121952

Citation

Brubaker PH, Moore JB, Stewart KP, Wesley DJ, Kitzman DW. Endurance exercise training in older patients with heart failure: results from a randomized, controlled, single-blind trial. J Am Geriatr Soc. 2009 Nov;57(11):1982-9. doi: 10.1111/j.1532-5415.2009.02499.x.

Results Reference

result

PubMed Identifier

20562334

Citation

John JM, Haykowsky M, Brubaker P, Stewart K, Kitzman DW. Decreased left ventricular distensibility in response to postural change in older patients with heart failure and preserved ejection fraction. Am J Physiol Heart Circ Physiol. 2010 Sep;299(3):H883-9. doi: 10.1152/ajpheart.00332.2010. Epub 2010 Jun 18.

Results Reference

result

PubMed Identifier

21737017

Citation

Haykowsky MJ, Brubaker PH, John JM, Stewart KP, Morgan TM, Kitzman DW. Determinants of exercise intolerance in elderly heart failure patients with preserved ejection fraction. J Am Coll Cardiol. 2011 Jul 12;58(3):265-74. doi: 10.1016/j.jacc.2011.02.055.

Results Reference

result

PubMed Identifier

22766338

Citation

Haykowsky MJ, Brubaker PH, Stewart KP, Morgan TM, Eggebeen J, Kitzman DW. Effect of endurance training on the determinants of peak exercise oxygen consumption in elderly patients with stable compensated heart failure and preserved ejection fraction. J Am Coll Cardiol. 2012 Jul 10;60(2):120-8. doi: 10.1016/j.jacc.2012.02.055.

Results Reference

result

PubMed Identifier

17517344

Citation

Moore B, Brubaker PH, Stewart KP, Kitzman DW. VE/VCO2 slope in older heart failure patients with normal versus reduced ejection fraction compared with age-matched healthy controls. J Card Fail. 2007 May;13(4):259-62. doi: 10.1016/j.cardfail.2006.12.005.

Results Reference

result

PubMed Identifier

16775543

Citation

Maldonado-Martin S, Brubaker PH, Kaminsky LA, Moore JB, Stewart KP, Kitzman DW. The relationship of a 6-min walk to VO(2 peak) and VT in older heart failure patients. Med Sci Sports Exerc. 2006 Jun;38(6):1047-53. doi: 10.1249/01.mss.0000222830.41735.14.

Results Reference

result

PubMed Identifier

16569976

Citation

Brubaker PH, Joo KC, Stewart KP, Fray B, Moore B, Kitzman DW. Chronotropic incompetence and its contribution to exercise intolerance in older heart failure patients. J Cardiopulm Rehabil. 2006 Mar-Apr;26(2):86-9. doi: 10.1097/00008483-200603000-00007. No abstract available.

Results Reference

result

PubMed Identifier

12972865

Citation

Brubaker PH, Marburger CT, Morgan TM, Fray B, Kitzman DW. Exercise responses of elderly patients with diastolic versus systolic heart failure. Med Sci Sports Exerc. 2003 Sep;35(9):1477-85. doi: 10.1249/01.MSS.0000084416.71232.EA.

Results Reference

result

PubMed Identifier

9781977

Citation

Marburger CT, Brubaker PH, Pollock WE, Morgan TM, Kitzman DW. Reproducibility of cardiopulmonary exercise testing in elderly patients with congestive heart failure. Am J Cardiol. 1998 Oct 1;82(7):905-9. doi: 10.1016/s0002-9149(98)00502-5.

Results Reference

result

PubMed Identifier

23665370

Citation

Kitzman DW, Brubaker PH, Herrington DM, Morgan TM, Stewart KP, Hundley WG, Abdelhamed A, Haykowsky MJ. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. J Am Coll Cardiol. 2013 Aug 13;62(7):584-92. doi: 10.1016/j.jacc.2013.04.033. Epub 2013 May 9.

Results Reference

result

PubMed Identifier

22522508

Citation

Haykowsky MJ, Herrington DM, Brubaker PH, Morgan TM, Hundley WG, Kitzman DW. Relationship of flow-mediated arterial dilation and exercise capacity in older patients with heart failure and preserved ejection fraction. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):161-7. doi: 10.1093/gerona/gls099. Epub 2012 Apr 20.

Results Reference

result

PubMed Identifier

23150511

Citation

Kitzman DW, Herrington DM, Brubaker PH, Moore JB, Eggebeen J, Haykowsky MJ. Carotid arterial stiffness and its relationship to exercise intolerance in older patients with heart failure and preserved ejection fraction. Hypertension. 2013 Jan;61(1):112-9. doi: 10.1161/HYPERTENSIONAHA.111.00163. Epub 2012 Nov 12.

Results Reference

result

PubMed Identifier

24507172

Citation

Haykowsky MJ, Kouba EJ, Brubaker PH, Nicklas BJ, Eggebeen J, Kitzman DW. Skeletal muscle composition and its relation to exercise intolerance in older patients with heart failure and preserved ejection fraction. Am J Cardiol. 2014 Apr 1;113(7):1211-6. doi: 10.1016/j.amjcard.2013.12.031. Epub 2014 Jan 15.

Results Reference

result

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Prospective Aerobic Reconditioning Intervention Study

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