COPDNCT04107831
Physical Function in Patients With Chronic Obstructive Pulmonary Disease
A study testing Pulmonary rehabilitation in people with COPD, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 9 Aug 2019to 31 Dec 2024
- 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
- Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) <0.7 and FEV1<80% of predicted value.
- Able to walk corridor and stairs
- Norwegian speaking
Who cannot join
- COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
- Not safe to exercise (e.g unstable angina)
- mental illness and drug abuse that makes group treatment not suitable
Trial locations and contacts
1 site in 1 country.
About this study
The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.
Read the detailed description
Patients with COPD who are participating at pulmonary rehabilitation (PR) at Haukeland University Hospital will be asked and consecutive enrolled to the study. Before and after PR the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.
- Conditions
- COPD
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary rehabilitation, Exercise, Field walk test, Physical performance test
- 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.
Pulmonary rehabilitationOther
Pre-post test design
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome
Measured: up to 6 weeks
Secondary outcomes (4)
Incremental Shuttle walk test
Change from baseline to 6 weeks in walk distance in meter is the outcome
Measured: up to 6 weeks
Endurance shuttle walk test
Change from baseline to 6 weeks in time in second is the outcome
Measured: up to 6 weeks
30 second sit to stand test
Change from baseline to in number of repetition is the outcome
Measured: up to 6 weeks
Stair test
Change from baseline to 6 weeks in time of the test is the outcome: 18 steps are walked up and down three times as fast as possible. Time in sec. is measured.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start9 Aug 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy, Western Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Else Sterndorff, Director, Study director, Haukeland University Hospital, Dept. of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107831
- Sponsor's protocol ID
- HaukelandUH- 2019/852
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Function in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04107831
- Acronym / sponsor ID
- HaukelandUH- 2019/852
- Conditions
- COPD
- Keywords
- Pulmonary rehabilitation, Exercise, Field walk test, Physical performance test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy, Western Norway University of Applied Sciences
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 2019 (actual)
- 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 aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.
Detailed description
Patients with COPD who are participating at pulmonary rehabilitation (PR) at Haukeland University Hospital will be asked and consecutive enrolled to the study. Before and after PR the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitationParticipants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) <0.7 and FEV1<80% of predicted value.
- Able to walk corridor and stairs
- Norwegian speaking
Key exclusion criteria (3 listed)
- COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
- Not safe to exercise (e.g unstable angina)
- mental illness and drug abuse that makes group treatment not suitable
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 rehabilitationPre-post test design | Other | Pulmonary rehabilitation |
Primary outcome
6-minute walk test
Time frame: up to 6 weeks
Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome
4 secondary outcomes
Incremental Shuttle walk test
Time frame: up to 6 weeks
Endurance shuttle walk test
Time frame: up to 6 weeks
30 second sit to stand test
Time frame: up to 6 weeks
Stair test
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Else Sterndorff, Director study director
Haukeland University Hospital, Dept. of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with COPD, run by Haukeland University Hospital at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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 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?
Results are not available in the source record.
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?
6-minute walk test (time frame: up to 6 weeks). 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 5 Jan 2024.