Chronic Obstructive Pulmonary DiseasePACNCT00948623
Physical Activity Counseling During Pulmonary Rehabilitation
A study testing physical activity counseling program in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- physical activity counseling program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2009to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spirometry-proven COPD
- Referred for 6-month outpatient pulmonary rehabilitation program
Who cannot join
- Orthopedic problems impairing daily activities
- Progressive neurological or neuromuscular disorders
- Psychiatric or cognitive disorders
- Patients on the waiting list for lung transplantation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences, University Hospitals KULeuven
Leuven, Vlaams-Brabant, 3000
Thierry Troosters, PT, PhD, +3216347107, thierry.troosters@med.kuleuven.be
About this study
Official title: Physical Activity Counseling During Pulmonary Rehabilitation: Does it Improve Daily Physical Activity Levels
This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- physical activity counseling program, sham counseling program
- Keywords
- COPD, physical activity, pulmonary rehabilitation, counseling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity counseling programBehavioural
sham counseling programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: physical activity counseling program |
| 2 | Sham comparator | Not described Receives: Behavioral: sham counseling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking time in daily life and the amount of time spent in moderate intense activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
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 DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948623
- Sponsor's protocol ID
- s06081980
- Acronym
- PAC
- Status last verified
- Jul 2009
- First submitted
- 28 Jul 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Burtin C, Langer D, van Remoortel H, Demeyer H, Gosselink R, Decramer M, Dobbels F, Janssens W, Troosters T. Physical Activity Counselling during Pulmonary Rehabilitation in Patients with COPD: A Randomised Controlled Trial. PLoS One. 2015 Dec 23;10(12):e0144989. doi: 10.1371/journal.pone.0144989. eCollection 2015.
PubMed 26697853Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
PubMed 24603844
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Counseling During Pulmonary Rehabilitation: Does it Improve Daily Physical Activity Levels
- ClinicalTrials.gov ID
- NCT00948623
- Acronym / sponsor ID
- PAC / s06081980
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, physical activity, pulmonary rehabilitation, counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Jul 2009 (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.
This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: physical activity counseling program |
| 2 | Sham comparator | Behavioral: sham counseling program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Spirometry-proven COPD
- Referred for 6-month outpatient pulmonary rehabilitation program
Key exclusion criteria (4 listed)
- Orthopedic problems impairing daily activities
- Progressive neurological or neuromuscular disorders
- Psychiatric or cognitive disorders
- Patients on the waiting list for lung transplantation
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 |
|---|---|---|
| physical activity counseling program | Behavioural | 1 |
| sham counseling program | Behavioural | 2 |
Primary outcome
Walking time in daily life and the amount of time spent in moderate intense activities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
- Derived from this study: PubMed 26697853Burtin C, Langer D, van Remoortel H, Demeyer H, Gosselink R, Decramer M, Dobbels F, Janssens W, Troosters T. Physical Activity Counselling during Pulmonary Rehabilitation in Patients with COPD: A Randomised Controlled Trial. PLoS One. 2015 Dec 23;10(12):e0144989. doi: 10.1371/journal.pone.0144989. eCollection 2015.
- Derived from this study: PubMed 24603844Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity counseling program in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Troosters, PT, PhD (+3216347107, chris.burtin@med.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking time in daily life and the amount of time spent in moderate intense activities. 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 NCT00948623, 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 30 Jul 2009.