NCT01113840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jul 1993

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1993

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

11.4 years

First QC Date

April 29, 2010

Last Update Submit

February 12, 2019

Conditions

Heart Failure

Keywords

elderlyheart failureexercisediastolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Peak exercise capacity

    16 weeks

Secondary Outcomes (1)

  • Quality of life

    16 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Exercise

ACTIVE COMPARATOR

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

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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

Exercise
ControlBEHAVIORAL

Control group continues daily life as prior to randomization.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (15)

  • 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.

    PMID: 12413374RESULT

  • 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.

    PMID: 20852060RESULT

  • 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.

    PMID: 20121952RESULT

  • 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.

    PMID: 20562334RESULT

  • 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.

    PMID: 21737017RESULT

  • 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.

    PMID: 22766338RESULT

  • 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.

    PMID: 17517344RESULT

  • 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.

    PMID: 16775543RESULT

  • 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.

    PMID: 16569976RESULT

  • 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.

    PMID: 12972865RESULT

  • 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.

    PMID: 9781977RESULT

  • 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.

    PMID: 23665370RESULT

  • 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.

    PMID: 22522508RESULT

  • 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.

    PMID: 23150511RESULT

  • 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.

    PMID: 24507172RESULT

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dalane W Kitzman, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2010

First Posted

April 30, 2010

Study Start

July 1, 1993

Primary Completion

December 1, 2004

Study Completion

December 1, 2009

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

US(1)