Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

Atherosclerosis Clinical Trial

Official title:

Randomized Clinical Trial to Assess the Efficacy and Cost-efficacy of Health Coaching to Promote Physical Activity in Secondary Prevention of Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01089842
• Other study ID #: PI08/90182
• Secondary ID: CIR08/034
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2010
• Last updated: March 18, 2010
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2010
• Source: Corporacion Parc Tauli
• Contact: Joan R Guma
• Phone: 0034937231010
• Email: jgumag[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of motivational interviewing-based coaching to increase physical activity to achieve guidelines recommendations for cardiovascular disease prevention.

Description:

Cardiovascular diseases are the main cause of death in developed countries. Epidemiological studies have shown that a sedentary lifestyle is associated with an increased risk of cardiovascular diseases, mainly related to classical risk factors (obesity, diabetes, hypertension). International guidelines recommend, because of that, a minimum of 30 minutes per day at least 5 days per week of moderate physical activity for primary and secondary cardiovascular disease prevention.

Physical inactivity is an increasing public health problem in developed countries. It is known that clinical advice has a poor efficacy to increase levels of physical activity on individuals and new strategies need to be developed.

Coaching is a strategy of personal help that is being widely and successfully used in business world. It consists of an structured and individualized process of assistance to people to promote cognitive changes needed to achieve behavioural changes. It can be a complementary method to information and sanitary education emphasizing on consciousness and responsibility of the patient and is now starting to be used in medical practice. The purpose of the study is to define usefulness of an strategy based on coaching techniques to promote physical activity practice and healthy lifestyle on individuals with known coronary heart disease or cardiovascular risk factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: January 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).

Exclusion Criteria:

• Bundle branch block or pacemaker rhythm

• Limitation or contraindication to moderate physical activity (fast walking)

• Unstable clinical situation

• Communication difficulties due to language or sensorial deficiencies.

• Lack of informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Health coaching
Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.

Other:
• Usual care
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients achieving recommended physical activity (>600 MET-minute/week)	Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)	6 months	No
Secondary	Cost-efficacy of coaching	Cost-efficacy will be measured using SF-12v2 quality of life questionnaire	6 months	No
Secondary	Improvement on functional capacity	Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention	6 months	No