Chronic Obstructive Pulmonary DiseaseNCT01320930
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)
A study testing Pulmonary rehabilitation and conventional care in people with Chronic Obstructive Pulmonary Disease, run by Bispebjerg Hospital.
Trial summary
The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation and conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A diagnosis of moderate COPD.
- Motivation for Pulmonary rehabilitation.
Who cannot join
- Comorbidity contraindicating rehabilitation.
- Participation in pulmonary rehabilitation within the last year.
- Cognitive disorders limiting the ability to participate in physical training and education sessions.
About this study
Official title: Early Detection and Rehabilitation of Subjects With COPD - Rehabilitation in Moderate COPD
The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation, conventional care
- Keywords
- Effect of Pulmonary rehabilitation., Exercise capacity, Quality of life
- 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.
Pulmonary rehabilitationBehavioural
conventional careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Active comparator | A standardized 7 week rehabilitation program, including physical training and education. Receives: Behavioral: Pulmonary rehabilitation |
| Control | Placebo comparator | Conventional care Receives: Behavioral: conventional care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, Danish Lung Association, Sygekassernes Helsefond
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320930
- Sponsor's protocol ID
- TORKOL1
- Status last verified
- Jan 2011
- First submitted
- 22 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Rehabilitation of Subjects With COPD - Rehabilitation in Moderate COPD
- ClinicalTrials.gov ID
- NCT01320930
- Acronym / sponsor ID
- TORKOL1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Effect of Pulmonary rehabilitation., Exercise capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, Danish Lung Association, Sygekassernes Helsefond
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Mar 2011 (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.
The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Active comparator | Behavioral: Pulmonary rehabilitationA standardized 7 week rehabilitation program, including physical training and education. |
| Control | Placebo comparator | Behavioral: conventional careConventional care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- A diagnosis of moderate COPD.
- Motivation for Pulmonary rehabilitation.
Key exclusion criteria (3 listed)
- Comorbidity contraindicating rehabilitation.
- Participation in pulmonary rehabilitation within the last year.
- Cognitive disorders limiting the ability to participate in physical training and education sessions.
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 |
|---|---|---|
| Pulmonary rehabilitation | Behavioural | Pulmonary rehabilitation |
| conventional care | Behavioural | Control |
Primary outcome
Not reported in the source record.
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 23 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation and conventional care in people with Chronic Obstructive Pulmonary Disease, run by Bispebjerg Hospital.
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 3 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 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
Where can I read the original study information?
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 23 Mar 2011.