The Effect of Physical Activity on Decreasing Risk Level

NCT03501017 | Completed

• 1 other identifier: 00001
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CVD Risk; Physical Activity; Nurse's Role; Risk Reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Opinions and Experiences about Physical Activity

  12 week

• Change in Physical activity level

  12 week

Study Arms (2)

Intervention group

EXPERIMENTAL

The 12-week physical activity program was implemented under the guidance of nurse, in outdoors with the group, 5 days a week with warm up and cooling down for 10 minutes and normal walking tempo at a moderate pace for 30-45 minutes (3-6 km/hour).

Other: physical activity program

Control Group

ACTIVE COMPARATOR

As routine practice, a brochure provided from the Public Health Directorate on protection from CVD was delivered to the individuals in the control group.

Other: Routine Practice

Interventions

physical activity program OTHER

The 12-week physical activity program was implemented under the guidance of nurse, in outdoors with the group, 5 days a week with warm up and cooling down for 10 minutes and normal walking tempo at a moderate pace for 30-45 minutes (3-6 km/hour). Application of WHO Smoking Cessation Algorithm: After fagerström test was applied, the modified smoking cessation algorithm of WHO was applied to the individuals and those who decided to quit smoking were referred to smoking cessation outpatient clinics.

Intervention group

Routine Practice OTHER

As routine practice, a brochure provided from the Public Health Directorate on protection from CVD was delivered to the individuals in the control group.

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged between 40 and 65 years,
• Not having a problem that could prevent walking activity,
• Being voluntary to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Motor Activity; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sebahat Gözüm, Prof

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 18, 2018
• Study Start: June 20, 2016
• Primary Completion: October 25, 2016
• Study Completion: December 20, 2016
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share