Exercise, Heart Failure, and Type 2 Diabetes

NCT ID: NCT02122835

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

heart failure

aerobic exercise training

Group Type OTHER

aerobic exercise training

Intervention Type BEHAVIORAL

12 weeks of supervised aerobic exercise training

heart failure plus type 2 diabetes

aerobic exercise training

Group Type OTHER

aerobic exercise training

Intervention Type BEHAVIORAL

12 weeks of supervised aerobic exercise training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aerobic exercise training

12 weeks of supervised aerobic exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥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).

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00032063

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.