Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000402448
Ethics application status
Approved
Date submitted
27/03/2016
Date registered
30/03/2016
Date last updated
30/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical activity, memory and attention in people with heart disease attending cardiac rehabilitation
Scientific title
Heart and mind: the impact of cardiac rehabilitation and physical activity on cognitive function in acute coronary syndrome survivors
Secondary ID [1] 288840 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity, memory and attention in people with heart disease attending cardiac rehabilitation 298122 0
Condition category
Condition code
Cardiovascular 298288 298288 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 298291 298291 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
16
Target follow-up type
Weeks
Description of intervention(s) / exposure
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.
Intervention code [1] 294296 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297772 0
The prevalence of cognitive impairment in patients who have coronary heart disease attending cardiac rehabilitation programs

Cognitive impairment assessed by subscales of COGSTATE (a web-based tool). These will be the “CogState Visual Attention / Vigilance - Identification Task” and the “CogState Psychomotor Function / Speed of Processing - Detection Task”
Timepoint [1] 297772 0
Baseline, 8 weeks and 16 weeks
Primary outcome [2] 297794 0
The association between physical activity (dose and duration) and cognitive function over time in patients who have coronary heart disease attending cardiac rehabilitation programs?

Physical activity will be measured subjectively and objectively. Subjective physical activity data will be collected using the Physical Activity Scale for the Elderly (PASE). Objective physical activity data will be collected using the Fitbit.

Cognitive impairment assessed by subscales of COGSTATE (a web-based tool). These will be the “CogState Visual Attention / Vigilance - Identification Task” and the “CogState Psychomotor Function / Speed of Processing - Detection Task”
Timepoint [2] 297794 0
Baseline, 8 weeks and 16 weeks
Secondary outcome [1] 322172 0
The reliability of innovative wearable devices (Fitbit device) in objective and continuous assessment of physical activity in coronary heart disease patients attending cardiac rehabilitation programs.

The test-retest reliability of Fitbit in measuring step counts and minutes of moderate to vigorous physical activity over four days.
Timepoint [1] 322172 0
baseline, 8 weeks and 16 weeks
Secondary outcome [2] 322275 0
The acceptability of innovative wearable devices (Fitbit device) in objective and continuous assessment of physical activity in coronary heart disease patients attending cardiac rehabilitation programs

Acceptability of the Fitbit device for patients, assessed by semi-structured interview with participants.
Timepoint [2] 322275 0
16 weeks

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Dementia diagnosis,
2- Inability to participate in regular physical activity (as assessed by the six-minute walk test)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The prevalence of cognitive impairment will be described using means and standard deviations, number and percentages. The impact of cardiac rehabilitation participation on cognitive status will be assessed by attendance at CR sessions (exercise and education) will be determined by comparing cognition at baseline and completion and follow-up (8 and 16 weeks) using repeated measures ANOVA. The relative influence of physical activity on cognitive function will be assessed by correlations with current cumulative engagement in physical activity using new technology (Fitbit) and by multiple linear regression analyses to account for baseline exercise capacity, functional status, baseline and current 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.

The prevalence of cognitive impairment will be described using means and standard deviations, number and percentages. The impact of cardiac rehabilitation participation on cognitive status will be assessed by attendance at CR sessions (exercise and education) will be determined by comparing cognition at baseline and completion and follow-up (8 and 16 weeks) using repeated measures ANOVA. The relative influence of physical activity on cognitive function will be assessed by correlations with current cumulative engagement in physical activity using new technology (Fitbit) and by multiple linear regression analyses to account for baseline exercise capacity, functional status, baseline and current depression, education level, age and gender.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
127
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5483 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 12967 0
2065 - Crows Nest

Funding & Sponsors
Funding source category [1] 293197 0
Government body
Name [1] 293197 0
National Health and Medical Research Council
Country [1] 293197 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, Charles Perkins Centre
Johns Hopkins Drive, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 292001 0
None
Name [1] 292001 0
Address [1] 292001 0
Country [1] 292001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294692 0
The Human Research Ethics Committee of Northern Sydney Local Health District
Ethics committee address [1] 294692 0
Reserve Road, ST LEONARDS NSW 2065
Ethics committee country [1] 294692 0
Australia
Date submitted for ethics approval [1] 294692 0
20/08/2015
Approval date [1] 294692 0
17/09/2015
Ethics approval number [1] 294692 0

Summary
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
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 64658 0
Prof Robyn Gallagher
Address 64658 0
Sydney Nursing School and Charles Perkins Centre, University of Sydney
Rm 2210, Lvl 2, The Hub D17
The University of Sydney
NSW 2006, Australia
Country 64658 0
Australia
Phone 64658 0
+61 2 86270279
Fax 64658 0
Email 64658 0
[email protected]
Contact person for public queries
Name 64659 0
Mr Muaddi Alharbi
Address 64659 0
Office W12 / Level 2 / Building 17, Charles Perkins Centre
University of Sydney, NSW, Australia, 2006
Country 64659 0
Australia
Phone 64659 0
+61 4 202 31 229
Fax 64659 0
Email 64659 0
[email protected]
Contact person for scientific queries
Name 64660 0
Prof Robyn Gallagher
Address 64660 0
Sydney Nursing School and Charles Perkins Centre, University of Sydney
Rm 2210, Lvl 2, The Hub D17
The University of Sydney
NSW 2006, Australia
Country 64660 0
Australia
Phone 64660 0
+61 2 86270279
Fax 64660 0
Email 64660 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.