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Sponsored by: |
Groningen Research Institute for Asthma and COPD |
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Information provided by: | Groningen Research Institute for Asthma and COPD |
ClinicalTrials.gov Identifier: | NCT00614796 |
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.
Condition | Intervention |
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Chronic Obstructive Pulmonary Disease (COPD) |
Behavioral: Coach, using a stepcounter with exercise counseling |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment |
Official Title: | A Study Evaluating the Effects of a Structured Lifestyle Intervention on Daily Physical Activity Level of COPD Patients in the First, Second and Third Echelon. |
Estimated Enrollment: | 150 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
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Behavioral: Coach, using a stepcounter with exercise counseling
5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
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2: No Intervention
daily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No counseling.
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Bossenbroek, Msc | +31 50 3614770 | L.Bossenbroek@cvr.umcg.nl |
Netherlands | |
University Medical Centre Groningen | Recruiting |
Groningen, Netherlands, 9700 RB | |
Contact: Johan B Wempe, Phd, MD +31 50 361 1160 j.b.wempe@cvr.umcg.nl | |
Principal Investigator: Linda Bossenbroek, MSc | |
Wilhelmina Ziekenhuis | Recruiting |
Assen, Netherlands | |
Contact: Peter van Hengel, MD Peter.vanHengel@wza.nl | |
Principal Investigator: Linda Bossenbroek, MSc | |
Diaconessenhuis | Recruiting |
Meppel, Netherlands | |
Contact: Wim CJ van Veldhuizen, MD veldhuizen@diacmeppel.nl | |
Principal Investigator: Linda Bossenbroek, Msc |
Principal Investigator: | Johan B Wempe, Phd, MD | University Medical Centre Groningen |
Responsible Party: | Groningen Institute for Asthma and COPD ( L. Bossenbroek ) |
Study ID Numbers: | COACH, NL12651.042.06 |
Study First Received: | January 31, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00614796 |
Health Authority: | Netherlands: Independent Ethics Committee |
COPD Lifestyle Pedometer |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |