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Physical activity, memory and attention in people with heart disease attending cardiac rehabilitation

Heart and mind: the impact of cardiac rehabilitation and physical activity on cognitive function in acute coronary syndrome survivors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000402448
Acronym
Nil
Enrollment
127
Registered
2016-03-30
Start date
2015-12-02
Completion date
2017-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cardiovascular disease (CVD) is a leading cause of mortality and morbidity and is known to contribute to cognitive impairment, a condition common in CVD patients. Cognitive impairment has been demonstrated to occur in 25-50% of heart failure patients and atrial fibrillation patients have a 42% increased hazard of dementia, a risk which increases with advancing age. However, little is known about cognitive impairment in acute coronary syndrome (ACS) survivors. Cognitive impairment is important to detect, manage and accommodate because it limits the capacity of these patients to engage in appropriate self-care. A potential platform to improve detection and treatment for cognitive impairment is cardiac rehabilitation (CR), because it includes routine screening and services for this population. Also, the regular exercise delivered in CR offers a potential means to attenuate cognitive decline, however this potential has not been investigated. There is a gap in the literature for a research study that will examine ACS patients attending CR for: 1) the prevalence of cognitive impairment, 2) the association between cognitive impairment and level of physical activity and attendance rate, and 3) the effect of CR on cognitive function. Cognitive impairment is prevalent in cardiovascular disease patients and important to detect, manage and accommodate because, even when mild, it can limit self-care capacity and engagement in secondary prevention behaviours. Mild cognitive impairment is likely to go undetected unless screening is undertaken. This study will investigate the prevalence of cognitive impairment in acute coronary syndrome survivors. The sample will be drawn from Royal North Shore Hospital in Northern Sydney Local Health District. Cognitive function will be assessed in the areas of processing speed, executive function and memory. Physical activity and moderate-vigorous exercise have been demonstrated to ameliorate cognitive changes in older adults in the general population and heart failure patients. The impact of comprehensive cardiac rehabilitation, which includes an 8-week structured physical activity program, will be determined by comparing cognition at baseline and completion and follow-up (8 and 16 weeks). The relative influence of physical activity will be assessed by measuring engagement in physical activity using new technology (Fitbit), while accounting for baseline exercise capacity, activities of daily living, depression, education level, age and gender. Sample size of 127 patients is calculated on a moderate effect on executive function, power of 0.8, allowing 20% loss to follow up. Study Aims & RESEARCH QUESTIONS Aims and objectives: 1. To investigate the prevalence of altered cognitive function in coronary heart disease patients ENTERING a comprehensive cardiac rehabilitation program 2. To explore the relationship between physical activity and cognitive function over 16 weeks in coronary heart disease patients attending a com

Interventions

The impact of comprehensive cardiac rehabilitation, which includes an 8-week structured physical activity program, will be determined by comparing cognition at baseline and completion and follow-up (8 and 16 weeks). The relative influence of physical activity will be assessed by measuring engagement in physical activity using new technology (Fitbit), while accounting for baseline exercise capacity, activities of daily living, depression, education level, age and gender. Potential participants

The impact of comprehensive cardiac rehabilitation, which includes an 8-week structured physical activity program, will be determined by comparing cognition at baseline and completion and follow-up (8 and 16 weeks). The relative influence of physical activity will be assessed by measuring engagement in physical activity using new technology (Fitbit), while accounting for baseline exercise capacity, activities of daily living, depression, education level, age and gender. Potential participants will be advised of the study through the Patient Information Sheet, which will be included in the routine documents posted by cardiac rehabilitation staff to all patients booked in for the program baseline assessment. When they attend for baseline assessment, potential participants will be screened for eligibility by the study research assistant in consultation with the cardiac rehabilitation coordinator, and if eligible, approached to consider joining the study. Interested patients will be given further information and time to consider the study before completing the consent form. After recruitment, participants will be provided interviews and/or provided with the self-administered questionnaires (sociodemographic information, physical activity habits, cognition and functional status), the Fitbit device applied and advice given along with a brief written guide on device placement and wearing time and problem-solving for the device. Participants will be advised to wear the device for four consecutive days while awake (from when you get up in the morning at 6:00 am until you go to bed at night at 9:00 pm except when showering) at baseline, 8 and 16 weeks .Data on clinical history, risk factors, anxiety and depression (Hospital Anxiety and Depression Scale), six-minute walk test, body mass, height and waist will be extracted from the cardiac rehabilitation chart for the patient. Data collection for physical activity, Fitbit activity, cognition and functional status will be repeated and data extracted from the cardiac rehabilitation data for six-minute walk test, anxiety and depression, and clinical events at eight weeks when the cardiac rehabilitation program is completed and patients have a discharge assessment, and at 16 weeks, 8 weeks after program completion. Data collection at baseline and 8 weeks will occur at the cardiac rehabilitation program site at Royal North Shore Hospital in a nearby private clinic room and at 16 weeks in a private room at the Kolling Research Institute beside Royal North Shore Hospital. Fitbit devices will be collected from participants for baseline measures at the next cardiac rehabilitation program session they attend that is at least four days following the baseline assessment, and at 8 and 16 weeks either by post in stamped, self-addressed post pack and/or in person at the cardiac rehabilitation program for participants who continue the program.

Sponsors

University of Sydney
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be eligible for the study if they 1) attend baseline assessment for cardiac rehabilitation at Royal North Shore Hospital, 2) were admitted for a diagnosis of acute coronary syndrome (ACS) (incorporates unstable angina, myocardial infarction (MI), primary and urgent percutaneous coronary intervention (PCI)), 3) able to participate in regular physical activity (as assessed by the six-minute walk test), 4) no dementia diagnosis, 5) able to understand English language sufficient to participate in the informed consent process and undertake the questionnaires, and 6) able to participate in the full 16 weeks of the study.

Exclusion criteria

1- Dementia diagnosis, 2- Inability to participate in regular physical activity (as assessed by the six-minute walk test)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026