Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02151266
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2014-05-28
Brief Title:
Exercise and Cognitive Retraining to Improve Cognition in Heart Failure
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Feasibility of Exercise and Cognitive Retraining to Improve Memory Attention and Concentration in Heart Failure
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCITE
Brief 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
Detailed Description:
Persons with heart failure HF have a four-fold greater likelihood of developing cognitive impairment CI than their age matched healthy counterparts placing them at high risk for adverse clinical outcomes poorer quality of life QOL and higher mortality CI is a subtle but measurable deficit in one or multiple cognitive domains it is a deficit greater than cognitive losses associated with normal aging The few studies that have documented CI in HF are inconsistent Few have used standard neuropsychological testing and little is known about change in cognitive function over time in HF Further if CI is detected there are currently no effective or evidenced-based guidelines to help restore or improve cognition in this populationDespite the aging population and projected rise of CI in HF only 2 small intervention studies have been documented indicating a critical need for further research in this area
The etiology of CI in HF is not fully understood but several underlying mechanisms are consistently reported reduced cerebral perfusion and oxygenation brain structural changes ie hippocampal damage atrophy loss of gray matter and micro emboliClinical studies have shown that CI is improved after cardiac transplantation and is modifiable with standard therapies that improve cardiac output oxygenation fluid overload and systemic and cerebral perfusion these findings are inconsistent and anecdotal The ability to positively influence cognitive function has important implications for patient adherence to a complex self-care regimen and the development of interventions that may partially reverse CI
Exercise improves clinical outcomes in HF by altering the deleterious peripheral and central mechanisms that contribute to HF exacerbations worsen symptom severity and lead to poor clinical outcomes Less is known about the effect of exercise on cognitive function Animal research has provided the most compelling evidence that exercise positively affects neuronal growth and the neural systems involved in learning and memory Similar human findings have emerged recent advances in neuroimaging support that participation in regular exercise leads to specific changes in brain structure and function Exercise is also thought to enhance brain plasticity BDNF appears to play a crucial role in this process when BDNF levels increase following exercise cognitive function improves The association between exercise BDNF and cognitive function has not been previously reported in HF This feasibility study will clarify these important relationships and increase the potential for improving clinical outcomes in a future trial
Neurogenesis and neuroplasticity are means for the brain to recover from poor perfusion and oxygen deprivation such as that occurring in HF Animal studies again provide the strongest evidence to date for using cognitive training CT to promote better cognitive functioning and provide a rationale for why a combined exercise and CT approach may be superior to monotherapy Animal studies show that like exercise learning tasks and performing cognitively stimulating activities also increase BDNF levels and improve learning and memory The effect of BDNF on brain function due to exercise however is thought to be different from that occurring with CT Exercise increases the proliferation and division of neuronal cells through BDNF whereas CT appears to promote cell survivalsuggesting a synergistic relationship may exist with greater benefit obtained when both are used together The combination of exercise and plasticity-based CT has not been previously tested in HF or in other populations as an intervention for improving cognitive outcomes but may be most optimal for targeting the underlying mechanisms for CI in HF The proposed feasibility study is designed to test the acceptability implementation and limited efficacy of a combined exercise Ex and cognitive training CT intervention in stable NYHA class II and III heart failure patients with cognitive impairment A total of 60 participants will be randomized to one of three study arms ExCT N20 Ex-alone N20 and attention control N20 The study aims are
Aim 1 To evaluate the feasibility of a 3-arm intervention ExCT Ex AC in heart failure patients with CI
Aim 1a To test the acceptability and implementation of each study arm Aim 2 To ascertain limited efficacy of the 3-arm intervention on changes in cognitive abilities Aim 3 To ascertain limited efficacy of the 3-arm intervention to improve cerebral oxygenation physiological status physical function and QOL
The etiology of CI in HF is not fully understood but several underlying mechanisms are consistently reported reduced cerebral perfusion and oxygenation brain structural changes ie hippocampal damage atrophy loss of gray matter and micro emboliClinical studies have shown that CI is improved after cardiac transplantation and is modifiable with standard therapies that improve cardiac output oxygenation fluid overload and systemic and cerebral perfusion these findings are inconsistent and anecdotal The ability to positively influence cognitive function has important implications for patient adherence to a complex self-care regimen and the development of interventions that may partially reverse CI
Exercise improves clinical outcomes in HF by altering the deleterious peripheral and central mechanisms that contribute to HF exacerbations worsen symptom severity and lead to poor clinical outcomes Less is known about the effect of exercise on cognitive function Animal research has provided the most compelling evidence that exercise positively affects neuronal growth and the neural systems involved in learning and memory Similar human findings have emerged recent advances in neuroimaging support that participation in regular exercise leads to specific changes in brain structure and function Exercise is also thought to enhance brain plasticity BDNF appears to play a crucial role in this process when BDNF levels increase following exercise cognitive function improves The association between exercise BDNF and cognitive function has not been previously reported in HF This feasibility study will clarify these important relationships and increase the potential for improving clinical outcomes in a future trial
Neurogenesis and neuroplasticity are means for the brain to recover from poor perfusion and oxygen deprivation such as that occurring in HF Animal studies again provide the strongest evidence to date for using cognitive training CT to promote better cognitive functioning and provide a rationale for why a combined exercise and CT approach may be superior to monotherapy Animal studies show that like exercise learning tasks and performing cognitively stimulating activities also increase BDNF levels and improve learning and memory The effect of BDNF on brain function due to exercise however is thought to be different from that occurring with CT Exercise increases the proliferation and division of neuronal cells through BDNF whereas CT appears to promote cell survivalsuggesting a synergistic relationship may exist with greater benefit obtained when both are used together The combination of exercise and plasticity-based CT has not been previously tested in HF or in other populations as an intervention for improving cognitive outcomes but may be most optimal for targeting the underlying mechanisms for CI in HF The proposed feasibility study is designed to test the acceptability implementation and limited efficacy of a combined exercise Ex and cognitive training CT intervention in stable NYHA class II and III heart failure patients with cognitive impairment A total of 60 participants will be randomized to one of three study arms ExCT N20 Ex-alone N20 and attention control N20 The study aims are
Aim 1 To evaluate the feasibility of a 3-arm intervention ExCT Ex AC in heart failure patients with CI
Aim 1a To test the acceptability and implementation of each study arm Aim 2 To ascertain limited efficacy of the 3-arm intervention on changes in cognitive abilities Aim 3 To ascertain limited efficacy of the 3-arm intervention to improve cerebral oxygenation physiological status physical function and QOL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30NR014134 | NIH | None | httpsreporternihgovquickSearchP30NR014134 |