Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.
Completed · Not applicable
Conditions studied: Heart Failure
In brief
Cognitive impairment (CI) is a prevalent problem in persons with HF heart failure (HF) and is associated with adverse clinical outcomes, higher mortality and poorer quality of life. Studies designed to attenuate or alleviate CI in persons with HF are limited, and evidenced based guidelines for screening and provision of care are practically nonexistent. Improvement in cognition has been reported following some therapies in HF and is thought to be the consequence of enhanced cerebral perfusion and oxygenation, suggesting that CI may be amenable to intervention in this population. Exercise is documented to increase cerebral perfusion and oxygenation by promoting neuroplasticity and neurogenesis, and, in turn, cognitive functioning. Brain derived neurotrophic factor (BDNF) is a key mechanism underlying the effect of exercise, but most studies of BDNF have not included individuals with CI or chronic illness populations, and its relationship to cognitive outcomes in HF is unknown. Cognitive retraining techniques, originally developed to treat traumatic brain injury, have also shown efficacy in broader neurologically-affected conditions and may provide added benefit to that of exercise. Animal studies suggest exercise and plasticity-based cognitive training could act synergistically through different neural mechanisms to have a more pronounced and positive impact on cognitive outcomes than either approach alone; but this has not been previously tested as an intervention to improve CI. The proposed feasibility study is designed to test the acceptability and limited efficacy of a combined exercise (Ex) and cognitive training (CT) program to improve CI in stable NYHA class II and III HF patients compared to either exercise alone or a no-intervention, attention-control group. Findings will be used to support the development of a future, large scale study to test the efficacy of this intervention to improve cognitive functioning, quality of life, and physiological markers of improved brain function in HF. In addition, we have an optional sub-study that participants may participate in order to further our understanding of biomarkers of inflammation and gen e expression before and after exercise.
Key facts
- Study ID
- NCT02151266
- Run by
- Emory University
- People needed
- 69
- Starts
- 2013-07-01
- Expected to finish
- 2017-12-30
- Last updated by the study team
- 2021-01-25
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- men and women between the ages of 40 and 75; English speaking; live independently within a 60 mile radius of Atlanta; meet education corrected cut-offs on the MMSE indicating cognitive impairment (score of 20 for 8-9 yrs of schooling; 22 for 10-12 yrs of schooling; 23 for >12 yrs) have a computer with internet connection; documented medical diagnosis of NYHA class II or III systolic. Left ventricular ejection fraction (LVEF) ≥ 10% that is documented within the last year by echocardiogram, cardiac catheterization ventriculography or radionuclide ventriculography; Receiving medication therapy for HF according to American College of Cardiology (ACC) American Heart recommendation guidelines for at least 8 weeks prior to study enrollment.
You may not qualify if…
- NYHA class I or IV; change in HF therapy within 8 weeks; worsening HF symptoms within last 5 days; unstable angina; renal insufficiency (serum creatinine > 3.o mg/dL); fixed rate pacemaker; uncontrolled hypertension; not involved in any structured exercise program or exercising 3 or more times per week for a minimum of 30 minutes and; not hospitalized within the last 30-days; not diagnosed with any neurological disorder that may interfere with cognitive function; Beck Depression Inventory II (BDI-II) score greater than 25; any disorder interfering with exercise participation.
Where it is running
- Emory University Heart Failure Clinics — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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