N/A N=69 Randomized Single-blind Supportive Care

Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02151266 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Verbal Memory Score Change — -0.08; -0.08; 0.18; -0.47 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Exercise and Cognitive retraining (Behavioral); Exercise Only (Behavioral); Stretching and Flexibility (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Verbal Memory Score Change	-0.08; -0.08; 0.18; -0.47; 0.14; 0.37	—
PRIMARY Visual Memory Score Change	-0.09; -0.17; 0.29; -0.21; 0.08; 0.18	—
PRIMARY Change in Processing Speed/Attention Score	-0.09; -0.02; 0.12; -0.09; 0.13; -0.01	—
PRIMARY Change in Working Memory Score	-0.04; 0.09; -0.07; -0.03; 0.12; -0.16	—
PRIMARY Change in Reaction Time	0.14; 0.11; 0.29; -0.05; 0.07; 0.18	—
SECONDARY Functional Capacity	324.1; 355.1; 337.6; 311.1; 358.8; 388.4	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02151266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.