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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier:
NCT00614796
First received: January 31, 2008
Last updated: March 23, 2012
Last verified: November 2010
  Purpose

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
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: Coach, using a stepcounter with exercise counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Groningen Research Institute for Asthma and COPD:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 155
Study Start Date: November 2006
Study Completion Date: November 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
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.
Other Name: COACH
No Intervention: 2
daily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40-80 years
  • COPD GOLD stage I-IV
  • Written informed consent

Exclusion Criteria:

  • Comorbidity, like serious cardiovascular problems, serious limitations in neuromuscular performance and exacerbations in the previous two months, which can effect the outcome of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614796

Locations
Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Delfzicht ziekenhuis
Delfzijl, Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Diaconessenhuis
Meppel, Netherlands
Sponsors and Collaborators
Groningen Research Institute for Asthma and COPD
Investigators
Principal Investigator: Johan B Wempe, Phd, MD University Medical Centre Groningen
  More Information

No publications provided by Groningen Research Institute for Asthma and COPD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier: NCT00614796     History of Changes
Other Study ID Numbers: COACH, NL12651.042.06
Study First Received: January 31, 2008
Last Updated: March 23, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Groningen Research Institute for Asthma and COPD:
COPD
Lifestyle
Pedometer

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014