Cardiovascular Diseases Clinical Trial
Official title:
Effects of Primary Prevention on Non-communicable Disease in Elderly People-An Intervention Study in 70 Year Old Men and Women, the Healthy Aging Initiative
The number of elderly will increase rapidly in Europe in the next 30 years, which affects the
country's economic and social development, welfare, health care, and also the individuals.
Future challenges include creating opportunities for people to maintain a high well-being in
later stages of life, and coping with diseases and disability. Physical exercise and avoiding
obesity have the potential to increase quality of life in the elderly by preventing CVD and
stroke.
The proposed project is a intervention study where the overarching aim is to evaluate whether
a primary prevention with the focus of decreasing obesity and increasing objective measures
of physical activity will decrease the future risk of the endpoints cardiovascular disease,
stroke, diabetes, falls, fractures, dementia and death, in a population based cohort of
70-year-old women and men.
Specific aims: In a population based cohort of 5000, 70-year old women and men;
1. Investigate the association between risk factors assessed at baseline, with focus on
objective measures of physical activity and body fat distribution, and the endpoints
described above.
2. To investigate whether individuals given the prevention will have a lower future risk of
the endpoints described above than 70-year olds in general Swedish population, after
adjustments for differences in the different covariates at baseline.
In a second part, a follow up will be conducted after 5 years where all participants will be
tested again. One aim is to evaluate whether the changes in the risk factors assessed at
baseline, with focus of objective measures of physical activity and body fat distribution,
are associated with the risk of CVD and stroke. We will also again investigate whether the
intervention give will influence the future risk of non-communicable disease.
Effects of Primary Prevention on Non-communicable Disease in Elderly People-An Intervention
Study in 70 Year Old Men and Women, the Healthy Aging Initiative
Hypothesis and aims The number of elderly will increase rapidly in Europe in the next 30
years, which affects the country's economic and social development, welfare, health care, and
also the individuals. Future challenges include creating opportunities for people to maintain
a high well-being in later stages of life, and coping with diseases and disability. Physical
exercise and avoiding obesity have the potential to increase quality of life in the elderly
by preventing CVD and stroke.
The proposed project is a intervention study where the overarching aim is to evaluate whether
a primary prevention with the focus of decreasing obesity and increasing objective measures
of physical activity will decrease the future risk of the endpoints cardiovascular disease,
stroke, diabetes, falls, fractures, depression, dementia and death, in a population based
cohort of 70-year-old women and men.
Specific aims: In a population based cohort of 5000, 70-year old women and men;
1. Investigate the association between risk factors assessed at baseline, with focus on
objective measures of physical activity and body fat distribution, and the endpoints
described above.
2. To investigate whether individuals given the prevention will have a lower future risk of
the endpoints described above than 70-year olds in general Swedish population, after
adjustments for differences in the different covariates at baseline.
In a second part, a follow up will be conducted after 5 years where all participants will be
tested again. One aim is to evaluate whether the changes in the risk factors assessed at
baseline, with focus of objective measures of physical activity and body fat distribution,
are associated with the risk of non-communicable disease.
Working plan
Project overview- The Healthy Aging Initiative (HAI) HAI is a population-based health
examination and intervention where all individuals living in Umeå municipal area are invited
to participate when they are exactly 70 years old. Information from population registers is
used to contact eligible individuals, who received printed information about the research
project. Telephone contact is made shortly thereafter, during which individuals accept or
decline the invitation to participate. As we aim to investigate a sample representing the
general population, no eligible participant is excluded. The 70-year-old participants visit
the clinic at 2 occasions a week apart. At the first visit, traditional and potential novel
risk factors for non-communicable disease are measured (please see details below), blood
samples are sent for analyses, and participants are sent home with accelerometers to collect
data on physical activity and sedentary behavior. At the second visit, all participants are
informed about the results of tests performed. They also receive counseling with focus on
physical activity using motivational interviewing which is a directive patient-cantered
counseling style to help the participants to explore and resolve their ambivalence about
behavior change. Based on the results, the participants will also be given medical advice, or
referred to primary care for follow up. They are also contacted at 6 months, 12 months per
telephone for follow up, and we are planning for an in-clinic follow up after 5 years. The
project started 5 years ago with the aim to include 2500 men and 2500 women. October 12,
2017, 3700 individuals have been included with a participation rate of 71%.
Questionnaires, basic measurements and blood samples All participants are asked to answer a
comprehensive questionnaire organized in the following themes; socio-demography, lifestyle,
mood, cognition, living habits, woman´s health, and medical history. Height, weight, forced
expiratory flow, waist-hip ratio, blood pressure, blood glucose and blood lipids are
measured/analyzed during the visit using standardized methods. In addition all subjects are
asked to leave blood samples for later analyses of markers for primarily cardiovascular
disease. All subjects participating in the project are also asked to leave blood samples for
DNA extraction. In this DNA, candidate genes will be analyzed and finally a GWAS including
2.4 million genetic markers will be performed for the outcomes of physical activity, muscle
strength and body fat distribution, blood pressure, blood glucose and blood lipids. Blood
samples are stored in the local biobank until the preplanned analyses of risk factors for
non-communicable disease presented above.
Measurements of body fat distribution and ectopic fat Peripheral quantitative computed
tomography (pQCT 2000, Stratec, Germany) is used to obtain slices (taken as a percentage of
limb length from the distal end of tibia, is used to measure bone density and muscle density,
that is an estimate of ectopic fat accumulation at the 66% tibial scan site. Additionally,
areal bone density, visceral fat, subcutaneous fat and gynoid fat are measured using
dual-energy X-ray absorptiometry (DXA) and the new Corescan soft ware using a Lunar I-DXA (GE
Healthcare, Wauwatosa, WI, USA).
Objective measures of physical activity Objective measures of physical activity is measured
using a triaxial accelerometer (GT3X+, Maribo Medical, Denmark) during 1 week. The
accelerometer is worn around the waist as this place has been shown to produce the most
accurate results during validation.
Measurements of muscle strength, balance and gait Isometric muscle strength of the
non-dominant hand is measured using a validated isokinetic hand dynamometer. Postural
instability is studied when standing on a force plate with preferred placements of the feet.
The instability is estimated by calculating the variability in the centre of pressure in
relation to the supported foot area - with and without vision. The methods for testing have
been developed exclusively for this project since clinical measurements used today are
lacking in sensitivity. Details surrounding specific methods have been development in a joint
cooperation with researchers from the Department of Integrative Medical Biology, Physiology
unit (Professor Benoni Edin and Göran Westling, PhD).
Finally, we measure gait variability using a 6-meter gait test and the GAITRite system (CIR
Systems, Sparta, NJ, USA). There are two separate tests. The first is conducted using
self-selected speed without performing any tasks. The second is performed at a self-selected
speed while performing a dual-task to increase the involvement of higher cortical functions
on the gait variability. Balance and gait are of interest in the present project as measures
of frailty, and of interest with respect to the risk of falls and fractures.
After the health investigation when all data has been collected All participants are informed
about the results of the tests performed. Participants are also given advice based on their
results with special emphasis on increasing the amount of physical activity. They are also
advised to search medical care or referred based on risk factor evaluation.
Identification of non-communicable disease within the cohort. Information on diagnosis from
1987-01-01 and onwards is obtained by record linkage with the National Hospital Discharge
Register (HDR), covering all public inpatient care in Sweden, and the National Hospital
Outpatients Register, covering all public outpatient care in Sweden from 2003-01-01,
administered the National Board of Health and Welfare in Sweden. Diagnosis were recorded
using the International Classification of Diseases (ICD) version 9 (1987-1996) and version 10
(1997 and later). Deaths occurring during the study period are collected through the National
Cause of Death Register, administered by the Center for Epidemiology at the National Board of
Health and Welfare in Sweden.
Prescribed drugs for every subject in the cohorts based on social security number is
available from the National Prescription Database at the National Board of Health and Welfare
from 2005-07 and onward. Permission for merging data files has been obtained from the
National Board of Health and Welfare. Socioeconomic data will be searched at Statistics
Sweden (www.scb.se).
Statistical methods Differences between two different groups will be investigated using
student's t-test for independent samples and differences between 3 groups will be
investigated using Analysis of variance with Bonferroni's post-hoc test. Association between
risk factors and future risk of CVD, stroke and diabetes will be investigated using
multivariable adjusted Cox regression models. Cox regression models will also be used to
investigate changes in the different risk factors during the 5 years of follow up in relation
to the later risk of CVD, stroke and diabetes.
Statistical power To estimate the statistical power with respect to the effect of the cohort
investigated, we first evaluated the risk of disease and death in the total Swedish
population of 70-year old men and women that lived in Sweden 2006 (n=72375). During 5 years
of follow up, 8969 subjects died, 2695 individuals suffered a first myocardial infarction and
2855 suffered a stroke, according to national registers. If we assume a similar risk of CVD,
stroke and death in our cohort there will be 620 deaths and 383 incident cases of CVD or
stroke during 5 years of follow up. Thus, also under two-tailed hypothesis testing, the total
number of outcomes will enable detection of numerically small associations, and small
differences in associations. Concerning the evaluation of the intervention given among the
HAI participants, compared to the rest of the Swedish population of 70 year old men and
women, we assume that the intervention will reduce the future risk of the combined endpoint
death, myocardial infarction and stroke by at least 15%. If we then assume a sample size of
3500 individuals (in each group) and a significance level of 0.05, we will have 96% power to
detect a difference. Given that the control group will be much larger, the statistical power
is likely to be adequate also for detecting smaller differences between the groups.
Ethical considerations Only the research leader will have access to social security numbers
from where the identity can be traced from individual data. No individual data will be
presented. Permission for these studies has been obtained from the Regional Ethical Review
Board in Umeå and conforms to the World Medical Association Declaration of Helsinki (Dnr
07-031M with extensions), and for the genetic part (06-134 and 09-029).
Significance and clinical relevance Non-communicable disease is the main cause of death and
morbidity worldwide. The number of elderly will increase rapidly in the next 30 years and
currently there are severe economic problems for Swedish health care with decreasing number
of hospital beds and personnel as a result. The idea is that the very old should live at home
healthy longer and that health care should be provided outside hospitals and specialized
care. In another project we have investigated the incidence of myocardial infarction and
stroke in the total Swedish population above 50 years of age, i.e. in 3.29 million
individuals. In this cohort, 28,268 individuals suffered a myocardial infarction and 29,708
individuals suffered a stroke at a mean age of about 77 years in 2006. Thus, any preventive
measures that could decrease the future risk of CVD and stroke in our cohort of 70-year olds
would be of high importance. Furthermore, the potential of preventive measures in our cohort
is high given that; 41% of the participants collected so far have systolic blood pressure
above 140, 16% are obese (BMI of at least 30) and 61% of the participants do not reach the
minimal amount of physical activity as suggested by the World Health Organization.
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