A Structured Lifestyle Intervention on Daily Physical Activity Level in COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. COPD is
      characterized by a deterioration of lung function, a lowering physical activity level and a
      low state of quality of life.

      The aim of this randomized controlled study is to investigate the effects of a structured
      lifestyle program compared with usual care (in the first, second and third echelon) on the
      physical activity level of COPD patients.

      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.

      In the structured lifestyle program, patients will be stimulated individually to enhance a
      physically active lifestyle. The primary outcome parameter is daily physical activity (steps/
      day) assessed with a pedometer.

      According to the study protocol patients in the experimental group and the control group
      participate in four measurement sessions distributed over 15 months. In each assessment a
      physical fitness test, lung function and questionnaires are taken. Patients of the
      experimental group participate in five individual counseling sessions and one telephonic
      counseling.
    

Detailed description: 
      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.
    

Intervention name(s): Coach, using a stepcounter with exercise counseling
Intervention type(s): Behavioral
Intervention description(s): 5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
Other intervention name(s): COACH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: COPD; Lifestyle; Pedometer