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NCT02151266 · ClinicalTrials.gov registry record · NA

Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.

A NA study of Heart Failure, sponsored by Emory University.

Completed
Registry status
NA
Development phase
69
Enrollment target
1
Study location

NCT02151266 is a NA study of Heart Failure that has completed, run by Emory University. The registered enrollment target is 69 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02151266, a NA study of Heart Failure, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
69 participants
Enrollment target
1
Study location

Study 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 i

Conditions Studied

Interventions

  • BEHAVIORAL Exercise and Cognitive retraining
  • BEHAVIORAL Exercise Only
  • BEHAVIORAL Stretching and Flexibility

Study Locations (1)

Georgia

  • Emory University Heart Failure Clinics - Atlanta

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2013-07
Est. Completion 2017-12-30
Phase NA

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT02151266

The ClinicalTrials.gov registry entry for NCT02151266 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which Exercise and Cognitive retraining is the first listed.

NCT02151266 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT02151266 about?

NCT02151266 is a clinical study titled "Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.". 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 scree...

What is the current status of trial NCT02151266?

This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2013-07. Estimated completion is 2017-12-30.

What conditions does trial NCT02151266 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT02151266?

The interventions under investigation include: Exercise and Cognitive retraining (BEHAVIORAL), Exercise Only (BEHAVIORAL), Stretching and Flexibility (BEHAVIORAL).

Who is sponsoring clinical trial NCT02151266?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02151266 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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