A Structured Lifestyle Intervention on Daily Physical Activity Level in COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COACH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614796
• Other study ID #: COACH
• Secondary ID: NL12651.042.06
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: March 23, 2012
• Start date: November 2006
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Groningen Research Institute for Asthma and COPD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Wilhelmina Ziekenhuis	Assen
Netherlands	Delfzicht ziekenhuis	Delfzijl
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Diaconessenhuis	Meppel

Sponsors (1)

Lead Sponsor	Collaborator
Groningen Research Institute for Asthma and COPD

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily physical activity in steps counts a day		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	No
Secondary	Personal characteristics		assessment at baseline	No
Secondary	Body Mass Index		assessment at baseline, 3 months, 9 months and 15 months	No
Secondary	Fat Free Mass		assessment at baseline, 3 months, 9 months and 15 months	No
Secondary	Lung function (FEV1)		assessment at baseline, 3 months, 9 months and 15 months	No
Secondary	Physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT)		assessment at baseline, 3 months, 9 months and 15 months	No
Secondary	COPD related costs		assessment at 3 months, 9 months and 15 months	No
Secondary	Type of activity, attitude towards physical activity, health status, physical fitness, psychological factors (self-efficacy, depression), quality of life, fatigue.		assessment at baseline, 3 months, 9 months and 15 months	No