Physical Activity Clinical Trial
Official title:
The Effect of Physical Activity Performed Under the Guidance of Nurse to the Individuals With Moderate Risk of Cardiovascular Disease on Decreasing Risk Level: Randomized Controlled Study
Objective: The aim of the first part of this study with two stages is to determine prevalence
of CVD risk and the associated variables in individuals aged 40-65 years registered in a
Family Health Center (FHC) in city center of Antalya; the aim of the second one is to
evaluate the effect of intervention to increase physical activity in individuals with
moderate risk of CVD on decreasing the risk level.
Methods: Stage 1 and Stage 2 were conducted as cross-sectional and Randomized Controlled
Experimental Trial, respectively.
In the first stage the CVD risk level was calculated using the HeartScore. In the second
stage, 11 individuals with moderate CVD risk (2-<5%) found in the intervention group
participated into a 12-week physical activity program (a moderate walk outdoor, with group 5
days in a week, each lasting for 40 minutes) guided by nurse. CVD brochure and physical
activity guide was distributed to 11 individuals in control group within the scope of routine
practice of FHCs.
The purpose of this study is to determine Cardiovascular Disease (CVD) risk level in 40-65
year-old individuals coming to a FHC and to evaluate the effect of increasing the physical
activity and interventions about the changeable risk factors on reducing the risk level in
individuals with moderate CVD risk.
Hypothesis; the 12-week group walking activity about changing CVD risk factors reduces the
risk level more in intervention group compared to the control group (H1).
It provides blood pressure control in the intervention group. It reduces cholesterol. It
helps reducing the weight, BMI, and waist circumference values. This study was conducted in
two stages. Stage 1: In order to determine the high risk prevalence of CVD, it was carried
out in Akdeniz FHC located in Konyaalti Central District of Antalya between April and
September 2016.
Stage 2: In order to evaluate the effect of the interventions for the changeable risk factors
(HeartScore 2-<5%) in individuals with moderate level of CVD risk, the study was conducted as
a Randomized Controlled Experimental Trial between October-December 2016 in April 23 Park
located near to FHC in the same region. There is a hiking trail around this park. This trail
is 860-meter long, covered with rubber, and suitable for walking. In addition, there are two
fields for exercise on apparatus in the east and west side of the park.
Stage 1 Population and Sample The population of the study consisted of 2390 individuals aged
between 40 and 65 years registered in the Akdeniz FHC. In the study, the sample size was
calculated by considering the CVD moderate risk prevalence (27.4%) obtained by Ünal et al. in
their study conducted with individuals living in Balcova region via the formula used in the
cases of known population and the minimum sample size for this study was determined as 27012.
However, 327 individuals were voluntary to participate in the study between the dates when
the study was conducted and their risk levels were calculated by using HeartScore® program.
Stage 2 Population and Sample Seventy two individuals who were found to have moderate risk as
a result of the first stage of the study constituted the population of this stage. 22 people
met the inclusion criteria of the study. When the sample size power was evaluated with Power
and Sample Size Calculation program for determining the difference between two dependent
numerical variables with the power of 80% and the error margin of 0.05 in Randomized
Controlled Trials (RCT), it was determined that minimum 9 people is sufficient for each
group.
Preliminary preparation The content of the study was explained to the individuals meeting the
inclusion criteria of the study in detail.
Current CVD risks of the individuals determined as the intervention group were re-measured
before the physical activity program and it was emphasized that their current risk can be
reduced after the 12-week program.
In order to encourage individuals to participate in physical activity programs, materials
such as pedometer, hats, and t-shirts were distributed before starting the program.
The feature of pedometer distributed to the individuals to keep time and distance of the
conducted activity was used. The necessary technical settings for the pedometer were made by
the researcher daily and weekly.
Healthy Beverage Distribution
•Individuals were asked to come with empty stomach and water was distributed before the walk
so that they could meet their fluid needs. They were advised to drink at least 2.5-3 liters
of water per day. In addition, in order to encourage the individuals to healthy diet, "ayran"
(a drink made with yoghurt and water), milk and mineral water were regularly distributed in
certain periods every day.
Intervention: 12-Week Physical Activity Program Physical activity program was administered to
all individuals in the experimental group whose risk was found as 2-<5% by evaluating their
all risk factors using HeartScore® program. In this direction, International Physical
Activity Questionnaire (IPAQ Short Form) was first applied to the individuals in order to
determine again their physical activity levels. Individuals determined to be inactive and
minimally active according to this measure were included in the physical activity program
recommended by the Ministry of Health and International Guidelines as a nonpharmacological
tool in primary prevention of CVD.
Duration of moderate intensity physical activity or aerobic exercise which can reduce total
and cardiovascular mortality are 2.5 - 5 hours a week; as the total period of the weekly
physical activity prolonged, the observed benefits increased as well. For this reason,
physical activity program was completed in such a way to complete minimum 150 minutes per
week. It was explained that the time individuals need to walk per week should be minimum 150
minutes. However, some individuals increased this time up to 200-250 minutes per week
according to their availability and willingness statuses.
With the pedometer distributed to the individuals, step, distance, pace and the calories
burned were recorded and these records were taken daily with the table prepared specific for
the individuals. The aim here was to increase their motivation by showing them the
developments in their physical activity levels. In addition, thanks to the record feature of
pedometer, the extra steps taken by individuals who wanted to continue to walk could be
recorded, the steps taken by the individuals who could not continue to walk due to personal
reasons (being sick, hospital appointment, etc.) and walked individually on that day were
also recorded.
In order to regularly determine the weight lost by the individuals and to increase their
motivations, Mondays in each week were determined as "Scale Day" and weight and waist
circumference values were measured and the obtained values were recorded.
Application of WHO Smoking Cessation Algorithm After fagerström test was applied, the
modified smoking cessation algorithm of World Health Organization (WHO) was applied to the
individuals and those who decided to quit smoking were referred to smoking cessation
outpatient clinics. For the individuals who decided to quit smoking, appointments were made
from the smoking cessation outpatient clinic located in Cancer Early Detection, Screening and
Education Center which provides free services.
Routine Practice for Control Group As routine practice, a brochure provided from the Public
Health Directorate on protection from CVD was delivered to the individuals in the control
group.
As the posttest to the individuals after applying the above-planned interventions;
HeartScore® risk level assessment, implementation of IPAQ questionnaire, BMI, weight and
waist circumference measurements were performed.
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