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Exercise for people with high cardiovascular risk

  1. Pamela Seron1,*,
  2. Fernando Lanas1,
  3. Hector Pardo Hernandez2,
  4. Xavier Bonfill Cosp3

Editorial Group: Cochrane Heart Group

Published Online: 13 AUG 2014

Assessed as up-to-date: 26 NOV 2013

DOI: 10.1002/14651858.CD009387.pub2


How to Cite

Seron P, Lanas F, Pardo Hernandez H, Bonfill Cosp X. Exercise for people with high cardiovascular risk. Cochrane Database of Systematic Reviews 2014, Issue 8. Art. No.: CD009387. DOI: 10.1002/14651858.CD009387.pub2.

Author Information

  1. 1

    Facultad de Medicina, Universidad de La Frontera, CIGES - Departamento de Medicina Interna, Temuco, Araucania, Chile

  2. 2

    Biomedical Research Institute Sant Pau (IIB Sant Pau), Iberoamerican Cochrane Centre, Barcelona, Catalunya, Spain

  3. 3

    CIBER Epidemiología y Salud Pública (CIBERESP), Spain - Universitat Autònoma de Barcelona, Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Catalonia, Spain

*Pamela Seron, CIGES - Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Montt112, 3º piso., Temuco, Araucania, 4780000, Chile. pamela.seron@ufrontera.cl.

Publication History

  1. Publication Status: New
  2. Published Online: 13 AUG 2014

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Characteristics of included studies [ordered by study ID]
Fukahori 1999

MethodsRCT conducted in 1996 in Japan involving 108 workers. Six-month follow-up with measurements at months 3 and 6


ParticipantsWorkers from a petroleum complex were recruited, 19-61 years of age, able to follow an exercise programme prescribed by an industrial physician, with two or more of the following risk factors:

- Hyperlipidemia (CholTotal≥220 mg/dl or HDL≤40 mg/dl)

- High blood pressure (SBP≥140 mmHg or DBP≥90 mmHg, no medication)

- Obesity (BMI≥24 kg/m2)

- Hyperglycaemia (fasting blood sugar≥110 mg/dl)


InterventionsThe experimental group underwent interval training on a treadmill, consisting of 2.5-minute walking with a 5% slope at 70-75% of the HRmax alternated with 3-minute flat walking, for a total of 20 minutes exercise

The exercise program was prescribed by an industrial physician in a work setting as part a health promotion plan

Sessions were conducted 3 times a week for 6 months during normal business hours

The control group received no exercise or alternative intervention


OutcomesTotal cholesterol, HDL cholesterol, and walking speed


NotesData to calculate total cardiovascular risk was not available. This study was included because it considers participants with two or more risk factors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskA total of 108 participants are randomized, 54 to each group, but a specific method to balance participants in each group is not defined

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot reported. In an exercise-based intervention, neither patients nor personnel can be blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskFive losses in the exercise group (9.2%) and two in the control group (3.7%). Reasons were change of job or injury

Selective reporting (reporting bias)Low riskIn the objectives section, authors state that effects on lipids and walking speed would be assessed. Both of these outcomes are reported

Hellenius 1993

MethodsRCT conducted in Japan involving 158 participants. Six-month follow-up


ParticipantsEligible participants included men with no cardiovascular disease, diabetes, or other severe disease history, taking no medication regularly and with:

- Cholesterol between 5.2 and 7.8 mmol/l

- Fasting triglycerides≤5.6 mmol/l

- DBP >100 mmHg


InterventionsSubjects were randomized to one of the following groups:

(1) Diet: Participants received counselling from a nutritionist based on the National Cholesterol Education Program Step 1 diet and considering a total fat consumption <30%; saturated fat <10%; polyunsaturated fat <10%; monounsaturated fat 10-15%; carbohydrates (complex) 50-60%; proteins 10-20% and cholesterol<300 mg/day

(2) Exercise: Participants were prescribed aerobic exercise (walking, jogging, etc) for 30-45 minutes at an intensity of 60-80% HRmax, 2-3 times a week. They were asked to keep an activity log with date, type of activity, time and intensity of exercise (using the Borg Scale). They were also given the opportunity to practice monitored exercise

(3) Group with diet plus exercise according to the previous description

(4) Control group: no diet or exercise intervention/advice

A physician provided verbal and written information about physical training in groups 2 and 3


OutcomesCardiovascular risk factors: weight, blood pressure, lipoproteins, and estimated risk of cardiovascular disease


NotesData to calculate probability of a cardiovascular event in 10 years (10-year Framingham risk) is available. In average, this probability was 13.2% (from 2.5% to 54.9%)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThe study describes randomization of participants to one of the four groups, but it does not mention methods to assure balance of participants in the final distribution of the groups

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot reported. In an exercise-based intervention, neither patients nor personnel can be blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly one subject lost in the control group

Selective reporting (reporting bias)High riskThe results are presented as differences between initial and final values

Mendivil 2006

MethodsParallel-group RCT conducted in Colombia involving 75 participants. 16-week follow-up


ParticipantsThe study included adults between 40 and 70 years of age with 10-year Framingham cardiovascular risk ≥1%. The study excluded individuals with diabetes mellitus, BMI under 18.5 kg/m2, chronic kidney failure, physical disability preventing exercise development, serious gastrointestinal disorders, malignant or secondary hypertension, recent acute myocardial infarction, unstable angina, or severe dental loss


InterventionsThe control group received a dietetic intervention which considered a caloric consumption computed according to ideal weight and exercise-related caloric expenditure. If BMI was >25, intake was reduced by 400 calories. Nutrients distribution was done following the NCEP-ATPIII

The intervention group received the same dietetic intervention plus aerobic exercise (dance, football, basketball, kick boxing) and resistance exercise with incremental time and intensity throughout the 16 weeks that lasted the intervention:

- Duration 45 minutes from week 1 to 12 and 60 minutes from week 13 to 16

- Intensity 50%-55% maximum HR from week 1 to 8, and 60%-70% maximum HR from week 9 to 16

- Dosage 3 times a week from week 1 to 8 and 5 times a week from week 9 to 16

All exercise sessions were directed and supervised by three trained physical therapists


OutcomesThe outcomes considered were: overall cardiovascular risk (10-year Framingham), total LDL and HDL cholesterol, and systolic and diastolic blood pressure


NotesThis study measured 10-year Framingham total cardiovascular risk. The mean value at baseline was 10.4% (95% CI 8.2 to 12.8)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomly assigned to control group or experimental group by a computer random number generator

Allocation concealment (selection bias)Unclear riskNot described, but the randomization method allows allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot reported. In an exercise-based intervention, neither patients nor personnel can be blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskThere were 43% and 26% losses in the exercise and control groups, respectively. The authors state that losses to follow-up

Selective reporting (reporting bias)Low riskAll pre-specified variable outcomes are reported

Nishijima 2007

MethodsParallel-group RTC conducted between 2003 and 2004 in Japan, involving 561 participants


ParticipantsThe study included participants 40-89 years of age with a BMI between 24.2–34.9 and two or more of the following cardiovascular risk factors:

- Systolic blood pressure at rest between 130 and 179 mmHg

- Fasting glycemia between 110 and 139 mg/dl, or HbA1c≥5.8, when casual blood sugar was 140-199 mg/dl

- LDL cholesterol between 120 and 219 mg/dl

The study excluded individuals with diastolic blood pressure ≥110 mmHg, history of heart disease or stroke, orthopedic problems interfering with exercise, abnormal ECG during exercise stress test, and those described by their private physician as unsuitable for exercising


InterventionsThe experimental group received advice on lifestyle and attended a fitness club where they performed aerobic exercise (cycling), ‘light’ resistance exercise, and stretching at the end of each session. Sessions were progressive regarding duration and intensity, starting at 60 minutes and reaching 90 at the end of the follow-up. Exercise load started at 40% VO2 peak, increasing from 5 to 10 watts in the following two phases. Resistance exercises were mild to moderate

The intervention period lasted 6 months. Participants performed 8 sessions with a coach and conducted the exercises on their own the rest of the time, 2-4 times a week

A certified fitness instructor directly supervised the exercise routine

The control group received advice on lifestyle


OutcomesSystolic blood pressure, LDL cholesterol and HbA1c were considered as primary outcomes. Secondary outcomes included hsCRP, waist circumference, VO2 peak, and health-related quality of life


NotesThe information needed to estimate the probability of a cardiovascular event in 10 years (10-year Framingham risk) is available. On average, this probability was 15.7% (from 6% to 68.3%)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA ‘lottery-like’ (4 or 6) block randomization was implemented. Stratification according to fitness club, age, and sex was carried out

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot reported. In an exercise-based intervention, neither patients nor personnel can be blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe study describes that staff administrating the exercise and the exercise stress tests were blinded. However, it does not specify whether the remaining assessments were conducted in a blinded manner

Incomplete outcome data (attrition bias)
All outcomes
Low risk11.4% of participants were lost to follow-up in the exercise group and 10% in the control group. Reasons for leaving the study were similar in both groups

Selective reporting (reporting bias)Low riskThe primary and secondary outcomes described in the methods section are reported in the results

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Anderssen 1995Participants with multiple risk factors, but not necessarily with increased cardiovascular risk. The results were markers of homeostasis, which are not relevant to this review

Avram 2011Compared intensive lifestyle counselling (diet and exercise indication) versus usual care. Exercise was not an isolated intervention

Cupples 1999Subsequent follow-up of participants from an RCT. The intervention was health promotion activities and combined several actions

Englert 2007The intervention is combined (education on diet, exercise, and smoking) and there is no control group

Eriksson 2009Compared exercise plus diet counselling (intensive modification of lifestyle) versus indication of diet plus exercise. Evaluates diet, not exercise

From 2010The intervention evaluated is exercise promoted by a nurse. Participants included men with at least two risk factors, which is not necessarily increased cardiovascular risk. No statistical results reported

Goodpaster 2010Severely obese participants, but not necessarily at increased cardiovascular risk (with other risk factors). 10-year Framingham risk score calculated at baseline: average of 9%

Hazar 2010Observational study. Outcomes are muscle damage and inflammation markers

Hussein 2010Patients with a coronary event, which is an exclusion criterion

Jennings 1986Subjects were not at increased cardiovascular risk. Twelve normal participants were included

Kokkinos 1991It is a clinical trial, but not randomized

Madden 2010The outcome, baroreflex sensitivity, is not part of this review's inclusion criteria. Furthermore, it is unclear whether participants had all the cardiovascular risk factors listed or just one or some of them

Naito 2008Observational study comparing factories with and without workplace-based intervention program

Price 2008The intervention is not exercise. The study implements a factorial design to compare exposure to individualized cardiovascular risk estimation versus advice on lifestyle versus both versus none

Rahimian 2010Participating women were obese or overweight and hypertensive but in state 1, which cannot be defined as increased cardiovascular risk or 10-year Framingham risk score over 10%

Singh 1992Patients with cardiovascular risk factors, however, authors do not specify the total risk or if they had more than one risk factor. Available data are not sufficient to estimate the total cardiovascular risk, but the tables show small proportions of participants with risk factors (no more than 50 per group for each risk factor)

Torjesen 1997Participants have several cardiovascular risk factors, but in range not high enough to be considered increased cardiovascular risk. Basal data allowed estimating 10-year Framingham risk score, which was 8.3% in non-smokers and 16% in smokers

Tuthill 2007The intervention is combined. Participants included obese patients suffering from diabetes mellitus, who are high-risk patients but who had already been included in previous Cochrane reviews

Vadheim 2010The intervention was the motivation of achieving goals. There were no specific exercise routines

Watkins 2003Compares exercise versus exercise and diet in patients with syndrome X

Wu 2007It is a clinical trial, but not randomized. Women with at least one risk factor, which is not necessarily increased cardiovascular risk