Clinical trial NCT01089842: Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Atherosclerosis
Keywords: Secondary Prevention
Health Promotion
Behavioral Medicine
Exercise Therapy
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2010-03-19
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients achieving recommended physical activity (>600 MET-minute/week)
timeFrame: 6 months
Secondary outcomes:
measure: Cost-efficacy of coaching
timeFrame: 6 months
measure: Improvement on functional capacity
timeFrame: 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Joan R Guma
role: PRINCIPAL_INVESTIGATOR
References: