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

March 23, 2012 updated by: Groningen Research Institute for Asthma and COPD

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Assen, Netherlands
        • Wilhelmina ziekenhuis
      • Delfzijl, Netherlands
        • Delfzicht ziekenhuis
      • Groningen, Netherlands, 9700 RB
        • University Medical Centre Groningen
      • Meppel, Netherlands
        • Diaconessenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • COACH
No Intervention: 2
daily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Personal characteristics
Time Frame: assessment at baseline
assessment at baseline
Body Mass Index
Time Frame: assessment at baseline, 3 months, 9 months and 15 months
assessment at baseline, 3 months, 9 months and 15 months
Fat Free Mass
Time Frame: assessment at baseline, 3 months, 9 months and 15 months
assessment at baseline, 3 months, 9 months and 15 months
Lung function (FEV1)
Time Frame: assessment at baseline, 3 months, 9 months and 15 months
assessment at baseline, 3 months, 9 months and 15 months
Physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT)
Time Frame: assessment at baseline, 3 months, 9 months and 15 months
assessment at baseline, 3 months, 9 months and 15 months
COPD related costs
Time Frame: assessment at 3 months, 9 months and 15 months
assessment at 3 months, 9 months and 15 months
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
assessment at baseline, 3 months, 9 months and 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groningen Research Institute for Asthma and COPD

Investigators

  • Principal Investigator: Johan B Wempe, Phd, MD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COACH
  • NL12651.042.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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