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
Verified date | April 2018 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 20, 2016 |
Est. primary completion date | October 25, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Being aged between 40 and 65 years, - Not having a problem that could prevent walking activity, - Being voluntary to participate in the study. Exclusion Criteria: - Having a known and diagnosed CVD, being diagnosed with diabetes (they are evaluated to have a high risk in the European Guidelines on Cardiovascular Disease Prevention and treatment is recommended), - Having walking disabled, - Not being voluntary to participate in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CVD risk level | "HeartScore® program" was used to determine the CVD risk level in the first stage of the study. In the second part, the risk level was evaluated using HeartScore program for the second time. HeartScore® is a primary prevention tool that provides risk measurement for people who have not had any cardiovascular disease. According to the SCORE score calculated in the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice, individuals are divided into 4 risk categories. Accordingly, if SCORE score is; =%10, very high risk category, Between =%5- <%10, high risk category Between =%2- <5, moderate risk category, <%1, then they are in the low risk category. |
12 week | |
Secondary | Change in Opinions and Experiences about Physical Activity | Participants' thoughts and experiences related to physical activity were assessed with a semi-structured interview form. Each participant was interviewed once. The duration of the interview continued to the point where no new information or opinion was obtained. | 12 week | |
Secondary | Change in Physical activity level | Physical activity level was measured by using Short Form of International Physical Activity Questionnaire (IPAQ). Short form (7 questions); provides information about the time spent on waking, moderate-intensity and vigorous-intensity activities, and the time spent on sitting. IPAQ classifies individuals categorically as "inactive", "minimally active", and "very active". |
12 week |
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