NCT02122835

Brief Summary

The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

June 15, 2023

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

April 18, 2014

Last Update Submit

June 13, 2023

Conditions

Heart FailureType 2 Diabetes

Keywords

exerciseaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • exercise capacity

    measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness

    baseline, 12 weeks

Secondary Outcomes (2)

  • flow-mediated dilation

    baseline, 12 weeks

  • nitrite flux during exercise

    baseline, 12 weeks

Study Arms (2)

heart failure

OTHER

aerobic exercise training

Behavioral: aerobic exercise training

heart failure plus type 2 diabetes

OTHER

aerobic exercise training

Behavioral: aerobic exercise training

Interventions

aerobic exercise trainingBEHAVIORAL

12 weeks of supervised aerobic exercise training

heart failureheart failure plus type 2 diabetes

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥50 yr of age
  • New York Heart Association class II-III CHF and ejection fraction ≤35%
  • receiving optimal medical therapy
  • sedentary (≤ 30 min/wk structured physical activity).
  • Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).

You may not qualify if:

  • smoking
  • changes in medication ≤6 wk prior to enrollment
  • major cardiovascular event or procedure ≤6 wk prior to enrollment
  • foot ulcers
  • advanced neuropathy
  • co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
  • fixed rate pacemaker
  • type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • William Kraus, MD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 25, 2014

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Last Updated

June 15, 2023

Record last verified: 2015-05

Locations

US(1)