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Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Corporacion Parc Tauli.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089842
First Posted: March 19, 2010
Last Update Posted: March 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto de Salud Carlos III
Information provided by:
Corporacion Parc Tauli
  Purpose
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.

Condition Intervention
Coronary Disease Atherosclerosis Behavioral: Health coaching Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Patients achieving recommended physical activity (>600 MET-minute/week) [ Time Frame: 6 months ]
    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)


Secondary Outcome Measures:
  • Cost-efficacy of coaching [ Time Frame: 6 months ]
    Cost-efficacy will be measured using SF-12v2 quality of life questionnaire

  • Improvement on functional capacity [ Time Frame: 6 months ]
    Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention


Estimated Enrollment: 262
Study Start Date: June 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health coaching 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.
No Intervention: Control Other: Usual care
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089842


Contacts
Contact: Joan R Guma 0034937231010 jgumag@gmail.com

Locations
Spain
Hospital de Sabadell Recruiting
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Instituto de Salud Carlos III
Investigators
Principal Investigator: Joan R Guma Corporacion Parc Tauli
  More Information

Responsible Party: Joan R Guma, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01089842     History of Changes
Other Study ID Numbers: PI08/90182
CIR08/034 ( Other Grant/Funding Number: Institut Universitari Parc Taulí. Esfera UAB )
First Submitted: March 18, 2010
First Posted: March 19, 2010
Last Update Posted: March 19, 2010
Last Verified: February 2010

Keywords provided by Corporacion Parc Tauli:
Secondary Prevention
Health Promotion
Behavioral Medicine
Exercise Therapy

Additional relevant MeSH terms:
Heart Diseases
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases