NCT00871897

Brief Summary

People with heart failure may experience problems with cognitive function, including memory and attention. Cardiac rehabilitation, which is an individualized program for heart failure patients that aims to improve their heart health, may also improve cognitive function. This study will examine the relationship between heart failure and cognitive function and how undergoing cardiac rehabilitation affects cognitive function in older adults with heart failure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2009

Enrollment Period

3.2 years

First QC Date

March 27, 2009

Last Update Submit

July 28, 2016

Conditions

Heart Failure

Keywords

NeuropsychologyCardiac Rehabilitation

Study Arms (2)

Cardiac Rehabilitation

People with heart failure who elect to participate in cardiac rehabilitation.

No Cardiac Rehabiliation

People with heart failure who elect NOT to participate in cardiac rehabilitation.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with heart failure

You may qualify if:

  • Systolic heart failure confirmed by perfusion stress scan

You may not qualify if:

  • Has a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System

Akron, Ohio, 44309, United States

Location

Related Publications (2)

  • Walter FA, Gathright E, Redle JD, Gunstad J, Hughes JW. Depressive Symptoms are Associated with Heart Rate Variability Independently of Fitness: A Cross-Sectional Study of Patients with Heart Failure. Ann Behav Med. 2019 Oct 7;53(11):955-963. doi: 10.1093/abm/kaz006.

    PMID: 30958884DERIVED

  • Alosco ML, Spitznagel MB, van Dulmen M, Raz N, Cohen R, Sweet LH, Colbert LH, Josephson R, Hughes J, Rosneck J, Gunstad J. Cognitive function and treatment adherence in older adults with heart failure. Psychosom Med. 2012 Nov-Dec;74(9):965-73. doi: 10.1097/PSY.0b013e318272ef2a. Epub 2012 Oct 31.

    PMID: 23115344DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John Gunstad, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

July 29, 2016

Record last verified: 2009-12

Locations

US(1)