A Structured Lifestyle Intervention on Daily Physical Activity Level in COPD
COACH
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.
2 other identifiers
interventional
155
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMarch 26, 2012
November 1, 2010
2.8 years
January 31, 2008
March 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Personal characteristics
assessment at baseline
Body Mass Index
assessment at baseline, 3 months, 9 months and 15 months
Fat Free Mass
assessment at baseline, 3 months, 9 months and 15 months
Lung function (FEV1)
assessment at baseline, 3 months, 9 months and 15 months
Physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT)
assessment at baseline, 3 months, 9 months and 15 months
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
2
NO INTERVENTIONdaily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No counseling.
Interventions
5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
Eligibility Criteria
You may qualify if:
- Age 40-80 years
- COPD GOLD stage I-IV
- Written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Wilhelmina Ziekenhuis
Assen, Netherlands
Delfzicht ziekenhuis
Delfzijl, Netherlands
University Medical Centre Groningen
Groningen, 9700 RB, Netherlands
Diaconessenhuis
Meppel, Netherlands
Related Publications (2)
Altenburg WA, ten Hacken NH, Bossenbroek L, Kerstjens HA, de Greef MH, Wempe JB. Short- and long-term effects of a physical activity counselling programme in COPD: a randomized controlled trial. Respir Med. 2015 Jan;109(1):112-21. doi: 10.1016/j.rmed.2014.10.020. Epub 2014 Nov 22.
PMID: 25499548DERIVEDAltenburg WA, Bossenbroek L, de Greef MH, Kerstjens HA, ten Hacken NH, Wempe JB. Functional and psychological variables both affect daily physical activity in COPD: a structural equations model. Respir Med. 2013 Nov;107(11):1740-7. doi: 10.1016/j.rmed.2013.06.002. Epub 2013 Jun 28.
PMID: 23810269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan B Wempe, Phd, MD
University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
November 1, 2006
Primary Completion
August 1, 2009
Study Completion
November 1, 2010
Last Updated
March 26, 2012
Record last verified: 2010-11