A Structured Lifestyle Intervention on Daily Physical Activity Level in COPD (COACH)

• Daily physical activity in steps counts a day [ Time Frame: Experimental group: assessment during first 3 months, 2 week assessment at 6 months, 9 months and 15 months. Control group: 2 weeks assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  

• Personal characteristics [ Time Frame: assessment at baseline ] [ Designated as safety issue: No ]
  
• Body Mass Index [ Time Frame: assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  
• Fat Free Mass [ Time Frame: assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  
• Lung function (FEV1) [ Time Frame: assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  
• Physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT) [ Time Frame: assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  
• COPD related costs [ Time Frame: assessment at 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  
• Type of activity, attitude towards physical activity, health status, physical fitness, psychological factors (self-efficacy, depression), quality of life, fatigue. [ Time Frame: assessment at baseline, 3 months, 9 months and 15 months ] [ Designated as safety issue: No ]
  

Background of the study: Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. The incidence of COPD is about 2-3 per 1000 and the prevalence of 12-19 per 1000 patients in the Dutch primary health care. The World Health Organization (WHO) states that its prevalence in 2020 will be on the fourth rank of death and the fifth rank of causes of disability-adjusted life years lost worldwide. COPD is characterized by a deterioration of lung function, a lowering physical activity level and a low state of quality of life.

Objective of the study: The aim of the study is to investigate the effects of a structured lifestyle program (in the first, second and third echelon) on the physical activity level of COPD patients

Study design: It concerns a randomized controlled study. In this study a structured lifestyle program will be compared with usual care in the first, second and third echelon of the health care.

Study population: 150 COPD patients (GOLD I-IV) will be included, aged between 40 and 80 years. In each echelon 25 patients will participate in a structured lifestyle program and 25 patients will be treated with usual care.

Intervention: A structured lifestyle program, based on the COACH method, will be used. This method was developed by the Institute of Human Movement Sciences of the University of Groningen (RUG). Using COACH, patients will be stimulated individually to enhance a physically active lifestyle.

Primary study parameters/outcome of the study: Daily physical activity (steps/ day)

Secondary study parameters/outcome of the study: Personal characteristics, Body Mass Index, Fat Free Mass, lung function (FEV1), physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT), COPD related costs, ADL activities, type of activity, attitude towards physical activity, health status, physical fitness, psychological factors (self-efficacy, depression), quality of life, fatigue.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: According to the study protocol patients in the experimental group and the control group participate in five measurement sessions. In each assessment a physical fitness test, lung function, questionnaires is taken. Al participants wear a pedometer to registrate the number of steps a day during 2 weeks after each appointment. Patients of the experimental group participate in five individual counseling sessions and one telephonic counseling. As a result of the type of assessments used, the study has a very low risk profile.