Chronic Obstructive Pulmonary DiseaseNCT00887705
ADL- Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing ADL training in people with Chronic Obstructive Pulmonary Disease, run by LHL Helse at 2 sites in Norway.
Trial summary
ADL training of copd patients results in better execution of activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ADL training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesNorway
- Study dates
- May 2009to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- Referred for rehabilitation
- Age > 18 years
- Symptoms affecting ADL function
- 6 minute walk distance (6MWD) < 400 meters
Who cannot join
- Patients who smokes or has smoked during the last three months.
- LTOT
- Patients who has another disability
- Patients who can't read or speak Norwegian
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Glittreklinikken
Hakadal, Akershus, 1485
Glittreklinikken
Hakadal, 1485
About this study
Official title: Activities of Daily Living (ADL)-Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
ADL training of copd patients results in better execution of activities of daily living.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ADL training
- Keywords
- COPD, Pulmonary Rehabilitation, ADL-Training, COPD Rehabilitation
- 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.
ADL trainingBehavioural
The control group gets the standard rehabilitation programme which includes one hour ADL- training. The experimental group also gets the standard rehabilitation program, but instead of one hour they get an additional five hours ADL- training.
| Study group | Role | What they receive |
|---|---|---|
| 1: Standard rehabilitation programme | No intervention | Not described |
| 2. Additional ADL training | Experimental | Not described Receives: Behavioral: ADL training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure(COPM) - Self-perception of occupational performance and satisfaction.
Measured: Baseline, 4 weeks; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionJun 2010
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Investigators
- Morten S Ryg, Dr philos, Study director, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887705
- Sponsor's protocol ID
- GK-63
- Status last verified
- Jun 2010
- First submitted
- 14 Apr 2009
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activities of Daily Living (ADL)-Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00887705
- Acronym / sponsor ID
- GK-63
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pulmonary Rehabilitation, ADL-Training, COPD Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Apr 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.
ADL training of copd patients results in better execution of activities of daily living.
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: Standard rehabilitation programme | No intervention | – |
| 2. Additional ADL training | Experimental | Behavioral: ADL training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD
- Referred for rehabilitation
- Age > 18 years
- Symptoms affecting ADL function
- 6 minute walk distance (6MWD) < 400 meters
Key exclusion criteria (4 listed)
- Patients who smokes or has smoked during the last three months.
- LTOT
- Patients who has another disability
- Patients who can't read or speak Norwegian
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 |
|---|---|---|
| ADL trainingThe control group gets the standard rehabilitation programme which includes one hour ADL- training. The experimental group also gets the standard rehabilitation program, but instead of one hour they get an additional five hours ADL- training. | Behavioural | 2. Additional ADL training |
Primary outcome
Canadian Occupational Performance Measure(COPM) - Self-perception of occupational performance and satisfaction.
Time frame: Baseline, 4 weeks; 3 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 23 Jun 2010.
- Site of LHL (Norwegian association for lung and heart disease patients). Glittreklinikken is listed as part of the organizationLink provided by the sponsor.
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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.
Morten S Ryg, Dr philos study director
LHL Helse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADL training in people with Chronic Obstructive Pulmonary Disease, run by LHL Helse at 2 sites in Norway.
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 5 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: finished, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Canadian Occupational Performance Measure(COPM) - Self-perception of occupational performance and satisfaction. (time frame: Baseline, 4 weeks; 3 months). It is what the study was designed to measure, not a finding.
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 Jun 2010.