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Exercise, Heart Failure, and Type 2 Diabetes

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Duke University

Status

Withdrawn

Conditions

Type 2 Diabetes
Heart Failure

Treatments

Behavioral: aerobic exercise training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02122835
Pro00032063

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

50 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

heart failure
Other group
Description:
aerobic exercise training
Treatment:
Behavioral: aerobic exercise training
heart failure plus type 2 diabetes
Other group
Description:
aerobic exercise training
Treatment:
Behavioral: aerobic exercise training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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