Chronic Obstructive Pulmonary Disease (COPD)COACHNCT00614796
A Structured Lifestyle Intervention on Daily Physical Activity Level in COPD
A study testing Coach, using a stepcounter with exercise counseling in people with Chronic Obstructive Pulmonary Disease (COPD), run by Groningen Research Institute for Asthma and COPD at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Coach, using a stepcounter with exercise counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 4 sitesNetherlands
- Study dates
- Nov 2006to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years
- COPD GOLD stage I-IV
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Wilhelmina Ziekenhuis
Assen
Delfzicht ziekenhuis
Delfzijl
University Medical Centre Groningen
Groningen, 9700 RB
Diaconessenhuis
Meppel
About this study
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.
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.
Read more
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.
Read the 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.
- Being tested
- Coach, using a stepcounter with exercise counseling
- Keywords
- COPD, Lifestyle, Pedometer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach, using a stepcounter with exercise counselingBehavioural
Also called COACH
5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Coach, using a stepcounter with exercise counseling |
| 2 | No intervention | daily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily physical activity in steps counts a day
Measured: 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
Measured: assessment at baseline
Body Mass Index
Measured: assessment at baseline, 3 months, 9 months and 15 months
Fat Free Mass
Measured: assessment at baseline, 3 months, 9 months and 15 months
Lung function (FEV1)
Measured: assessment at baseline, 3 months, 9 months and 15 months
Physical fitness (arm strength, leg strength, respiratory muscle strength, 6MWT)
Measured: assessment at baseline, 3 months, 9 months and 15 months
COPD related costs
Measured: 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.
Measured: assessment at baseline, 3 months, 9 months and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionAug 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groningen Research Institute for Asthma and COPD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan B Wempe, Phd, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614796
- Sponsor's protocol ID
- COACH
- Other IDs
- NL12651.042.06
- Acronym
- COACH
- Status last verified
- Nov 2010
- First submitted
- 31 Jan 2008
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25499548Altenburg 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.
PubMed 23810269
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00614796
- Acronym / sponsor ID
- COACH / COACH
- Keywords
- COPD, Lifestyle, Pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Groningen Research Institute for Asthma and COPDUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Coach, using a stepcounter with exercise counseling5 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 intervention | –daily physical activity is assessed at baseline, 3 months, 9 months and 15 months. No counseling. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-80 years
- COPD GOLD stage I-IV
- Written informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach, using a stepcounter with exercise counselingAlso: COACH5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle. | Behavioural | 1 |
Primary outcome
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
7 secondary outcomes
Personal characteristics
Time frame: assessment at baseline
Body Mass Index
Time frame: 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
Lung function (FEV1)
Time frame: 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
COPD related costs
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 25499548Altenburg 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.
- Derived from this study: PubMed 23810269Altenburg 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.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients With Chronic Respiratory Disease: a Randomized Cross-over Trial
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in COPD Patients
Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan B Wempe, Phd, MD principal investigator
University Medical Center Groningen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach, using a stepcounter with exercise counseling in people with Chronic Obstructive Pulmonary Disease (COPD), run by Groningen Research Institute for Asthma and COPD at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00614796, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.