Population survey on the prevalence of cardiovascular disease - multidisciplinary intervention in adults with hypertension

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-6673s5
• Date of registration: 25/05/2015
• Prospective Registration: No
• Primary sponsor: Universidade Estadual de Maringá
• Public title: Population survey on the prevalence of cardiovascular disease - multidisciplinary intervention in adults with hypertension
• Scientific title: Population survey on the prevalence of risk and protective factors for cardiovascular disease in the metropolitan region of Maringá
• Date of first enrolment: 16/01/2012
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-6673s5
• Study type: Intervention
• Study design: Randomized clinical trial, parallel , open, with two arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Cremilde Aparecida Trindade Radovanovic
• Affiliation: Universidade Estadual de Maringá

• Name: Cremilde Aparecida Trindade Radovanovic
• Affiliation: Universidade Estadual de Maringá

Key inclusion & exclusion criteria

Inclusion criteria: Medical certificate of fitness to practice physical exercises; interest and willingness to regularly attend the activities of the intervention; accepting perform all physical and biochemical evaluations on two occasions (before and after the start of the activities of the GI)
Exclusion criteria: Presenting disability to carry the exercise; do not accept accomplish all assessment proposals

Age minimum: 20Y
Age maximum: 59Y
Gender: -

Health Condition(s) or Problem(s) studied

Cardiovascular diseases, Hypertension

C14.907.489

Intervention(s)

G11.427.590.530.698.277

Behavioural

Intervention Group (16 weeks – 48 meetings)with 21 participants
Advising on health and nutrition
Carrying out of aerobic physical activities
Measurement of blood pressure in all meetings
The assessment of the anthropometric measurements were determined through the assessment body composition – multifrequency bioimpedance
Collection of biological specimens for analysis of the blood levels of total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglycerides (TG) and glucose



Control Group (16 weeks – 2 meetings)with 21 participants
Measurement of blood pressure
The assessment of the anthropometric measurements were determined trhough the assessment body composition – multifrequency bioimpedance
Collection of biological specimens for analysis of the blood levels of total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglycerides (TG) and glucose
These evaluations were performed before the start up to the intervention group and after completion of the activities

I02.233.332

Primary Outcome(s)

Completed study

Lower blood pressure

Group Intervention (IG)

Activities were carried out such as:
Nutritional guidelines: once a month, lasting an hour, totaling four meetings.
Health guidance: once a week, lasting an hour, totaling 12 meetings.
Performing aerobic exercise, three times a week, totaling 48 meetings, lasting 60 minutes each section. The physical exercises were divided into three stages: initial warm up and stretching (15 minutes) aerobic activity, followed by localized exercises (35 minutes), and ultimate stretching (10 minutes). The intensity of exercises varied between mild to moderate, and according to the limits of each person, using the cardiac frequency meter to estimate the appropriate rate to physical activity. The maximum heart frequency was calculated by the formula: 220 (-) age, and the heart frequency was established between 40-60% of the maximum heart frequency (Nieman, 2011). All people were monitored for the value of blood pressure in all sessions. Blood pressure was measured by the nurse - at the beginning (after 15 minutes of rest) and the end of the activities, as recommended by the VI Brazilian Guidelines for Hypertension, using the manual blood pressure monitor Missori®. The systolic blood pressure (SBP) was considered high when presented values equal or higher than 140 mmHg and diastolic (DBP) when presented values equal or higher than 90 mmHg (Brazilian Society of Cardiology, 2010).

The group began its activities with 21 people. Six participants gave up in the first month. In the second month other six people gave up, coming to the end (16 weeks) nine people, in the group. Because of given up, people who participated to the physical activities for two months or for four months were divided into two different groups for the analysis.
In the Intervention Group A (GIa) were included people who attended 16 weeks - (n = 9 - often 100%).
In the Intervention group B (GIb) were included people who attended 08 weeks - (n = 6 - often 50%).

As a result, the GIa group showed a statistically significant reduction in systolic blood pressure and diastolic blood pressure (132.2 ± 13.9 to 118.9 ± 8.7, p = 0.036 and 86.7 ± 9.4 to 77.8 ± 6.3, p = 0.041, respectively).

The GIb group presented a decrease in systolic blood pressure, which was statistically significant (143.3 ± 11.0 to 121.7 ± 14.6, p = 0.024), and also a decrease in diastolic blood pressure, but there were no statistically significant difference (95.0 ± 7.6 to 83.3 ± 12.5, p = 0.104).

Control group (CG)

Blood pressure was measured by the nurse - before and after the 16 weeks of intervention, as recommended by the VI Brazilian Guidelines for Hypertension, using the manual blood pressure monitor Missori®. The systolic blood pressure (SBP) was considered high when presented values equal or higher than 140 mmHg and diastolic (DBP) when presented values equal or higher than 90 mmHg (Brazilian Society of Cardiology, 2010).

As a result, the control group showed a decrease of systolic blood pressure and diastolic blood pressure (138.7 ± 13.8 to 128.7 ± 16.3, p = 0.112 and 88.7 ± 11.5 to 84.7 ± 9.6, p = 0.324, respectively) with no statistically significant difference.

Reduction of blood pressure

Intervention Group (IG)

To achieve the reduction of blood pressure, activities will be held such as:
Nutritional guidelines: once a month, lasting an hour.
Health guidelines: once a week, lasting one hour.
Carrying out aerobic physical activities, three times a week, lasting 60 minutes each section. The exercise will take place in three stages: initial warm up and stretching (15 minutes), aerobic activity followed by localized exercises (35 minutes), and ultimate stretching (10 minutes). The exercises will be carried out with intensity from mild to moderate and according to the limits of each person, with the use of cardiac frequency meter to estimate the appropriate rate to physical activity. Blood pressure will be measured at the beginning (after 15 minutes of rest) and at the end of the activities, as recommended by the VI Brazilian Guidelines for Hypertension.
All participants in the intervention group will be evaluated before and after the end (16 weeks) of activities.

Control Group(CG)

Blood pressure will be measured before and after the 16 weeks of intervention, as recommended by the VI Brazilian Guidelines for Hypertension, using the manual blood pressure monitor Missori®.

Secondary Outcome(s)

Reduction of anthropometric measurements and adequacy of biochemical parameters

Intervention Group (IG)

Anthropometric measurements
Weight and anthropometric indicators - body mass index (BMI), waist-hip ratio (WHR) and body fat percentage (PGC) will be determined through the assessment of body composition - multifrequency bioimpedance In Body brand, model 520®. The height is determined (in meters) by the use of anthropometric tape.

Biochemical variables
Blood will be collected for measurements of total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglycerides (TG), plasma glucose levels.
All participants in the intervention group will be evaluated before and after the end (16 weeks) of activities.

Control Group (CG)

All participants will perform the same anthropometric and biochemical assessments performed by intervention group, before and after the 16 weeks.

Completed Study

Intervention Group (IG)

Anthropometric measurements
The weight and anthropometric indicators - body mass index (BMI), waist-hip ratio (WHR) and body fat percentage (PGC) were determined by assessing body composition - multifrequency bioimpedance In Body brand, model 520®.
Height was determined (in meters) with an anthropometric tape.
As anthropometric indicators were used BMI, waist circumference (WC), waist-hip ratio (WHR) and hip circumference (HC). The BMI cut-off point used was that recommended by the WHO (World Health Organization, 2000) and is considered obese people with BMI > 30 kg/m2. The AC was measured at the midpoint between the costal margin and the iliac crest using a tape measure, and was considered abnormal when above 102 cm for men and 88 cm for women (World Health Organization, 2000). The waist-hip ratio was defined as the largest circumference around the buttocks above the gluteal fold, and considered inappropriate when above 0,90cm for men and 0,85cm for women.

As a result, the GIA, after 16 weeks, showed a decrease in values of all anthropometric variables, and revealed significant differences for CQ (108.9 ± 11.6 to 106.4 ± 12.1, p = 0.042) and WHR (1.00 ± 0.07 to 0.99 ± 0.07, p = 0.030).

The GIB showed a decrease only in the WHR (0.98 ± 0.06 to 0.97 ± 0.05).

Biochemical variables
Blood samples were collected for measurements of total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglycerides (TG) and plasma glucose levels. All subjects were instructed to fast for 12 hours.

As a result, the GIa had changes for all variables, and HDL showed a significant difference (50.4 ± 6.6 to 54.2 ± 7.8, p = 0.034).

The GIb showed changes in biochemical parameters of glucose, HDL and TG, with no statistically significant differences.

Control group (CG)

All 21 participants underwent the same anthropometric and biochemical assessments that the intervention group, before and after 16 weeks of intervention.

Showed a slight decrease in body fat percentage (38.0 ± 6.4 to 37.9 ± 6.9) and CQ (105.3 ± 6.4 to 103.6 ± 5.7), both showed no statistically significant difference.

The changes in biochemical variables showed a decrease in glucose parameters, TC, HDL and TG, with no statistically significant differences.

Source(s) of Monetary Support

Fundação Araucária

Secondary Sponsor(s)

Fundação Araucária