(CCSP082) THE RECARDIO TRIAL PROTOCOL: COMPARING THE EFFECTS OF COGNITIVE TRAINING AND PHYSICAL EXERCISE ON COGNITION AND CEREBRAL AUTOREGULATION IN MEN AND WOMEN WITH HEART FAILURE

Background: Cognitive impairment affects up to 50% of patients with heart failure (HF) and is associated with high mortality rates, poor quality of life and reduced functional capacities. There appears to be a bi-directional relationship between HF and cognitive impairment: HF induces cognitive impairment, which can lead to suboptimal treatment adherence that can deteriorate HF, and so on. Impaired cerebral autoregulation, the maintenance of a stable cerebral blood flow, could explain cognitive impairment in HF. Non-pharmacological interventions such as physical exercise and cognitive training, and their combination, show promising effects on cognition in frail older adults and those suffering from mild cognitive impairment. How this translates to HF is unknown. Moreover, female participants remain underrepresented in cardiovascular clinical trials, yet HF symptoms, treatment and prognosis vary with sex and exercise effects on cognition are influenced by sex.

Objective: This multicenter randomized controlled trial will investigate the effects of cognitive training and physical exercise on cognition and cerebral autoregulation and vasoreactivity in male and female patients with HF.

METHODS AND RESULTS: Two-hundred and sixteen participants (50% females; 50 years and over) with stable HF regardless of etiology and left ventricular ejection fraction will be randomized to one of the three following arms: 1/ Combined physical exercise and cognitive training; 2/ Physical exercise alone; 3/ Usual medical care. Participants will engage in a 6-month intervention. The novel exercise-training programs in Arms 1 and 2 are progressive and patient-tailored that combine aerobic and resistance exercises designed to improve participants’ physical function and fitness, and to improve cognition. Finally, the cognitive training targets memory and executive functions, both known to be affected by HF. The primary endpoint will be changes in cognitive performance from baseline to 6 months based on four cognitive composite scores (global cognitive functioning, memory, executive functions, processing speed). Secondary outcomes will include changes in cerebral autoregulation and cerebral vasoreactivity assessed with functional near-infrared spectroscopy and transcranial doppler. Tertiary outcomes will be changes in functional status, self-care, and quality of life.

Conclusion: This CIHR-funded multicenter randomized trial will address a specific primary hypothesis, that multidomain non-pharmacological interventions including physical exercise and cognitive training improve cognitive status over time compared with standard of care. Ultimately, results from this trial could eventually translate to cardiac rehabilitation programs and lifestyle prescription adapted to women and men with HF to not only improve fitness and physical function, but also to improve cognition and quality of life.