Chronic Obstructive Pulmonary DiseaseNCT02314338
The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by LHL Helse at 1 site in Norway.
Trial summary
Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- 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
- Sep 2014to Dec 2015
- 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
- Patients with all stages of COPD
- Decision making capacity to provide informed written consent
- Ability to understand and complete the questionnaires
Who cannot join
- Exacerbation within the last four weeks
- Co-morbidities that limits the patient's physical performance more than COPD
- Any patient whom is deemed unsafe to exercise
- Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short Physical Performance Battery in COPD - Possible Impact of a Pulmonary Rehabilitation Program and Relationships to Other Physical Performance Measures, Symptoms, and Quality of Life.
Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. SPPB has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. The investigators would like to evaluate possible changes in the SPPB score after a 4-week rehabilitation program. The investigators would also like to look at possible relationships between the SPPB and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary 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.
Pulmonary rehabilitationOther
In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Multi-disciplinary pulmonary rehabilitation Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short physical performance battery (SPPB)
SPPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.
Measured: Pre and posttest with 4 weeks in between
Secondary outcomes (9)
Lung function
spirometry and/or whole body plethysmography
Measured: 4 weeks
6-minute walk test (6MWT)
The 6 MWT is a timed walk test. Participants are asked to walk as far as possible, in 6 minutes. Borg CR-10 score and SpO2 will be measured before, during and/or after the 6 MWT.
Measured: 4 weeks
Borg category ratio-10 scale (Borg CR-10 scale)
The Borg CR-10 scale is a rating scale for self-reported symptoms, in this case dyspnea. 0 represents no symptoms and 10 the worst previously experienced symptoms.
Measured: 4 weeks
Peripheral oxygenation level
Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
Measured: 4 weeks
Bilateral leg press 1 repetition Maximum (RM)
1 RM bilateral leg press will be administered, after a brief warm-up, as a measure of leg strength. Starting position: Legs shoulder width apart and knee at 90 degrees angle.
Measured: 4 weeks
Modified Medical Research Council Dyspnea Scale (MMRC)
A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with COPD. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 is a person who are to breathless to leave the house, or breathless when dressing/undressing.
Measured: 4 weeks
COPD assessment test (CAT)
CAT is a disease-specific quality of life questionnaire. It has 8-items and a total range of 0-40, where 40 represents more severe impact of COPD on a patient's life.
Measured: 4 weeks
Hospital anxiety and depression scale (HADS)
14-item questionnaire for screening for anxiety and depression. Each item is scored from 0-3 and each person can have a score between 0-21 for either anxiety or depression.
Measured: 4 weeks
Fatigue severity scale (FSS)
9- item scale that measures the impact of fatigue on a person's activities and lifestyle. Range 9-63. Higher score- greater fatigue severity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Anne Edvardsen, PhD, Principal investigator, LHL-klinikkene Glittre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314338
- Sponsor's protocol ID
- REK2014/1499
- Status last verified
- Sep 2015
- First submitted
- 27 Nov 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsson P, Borge CR, Nygren-Bonnier M, Lerdal A, Edvardsen A. An evaluation of the short physical performance battery following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. BMC Res Notes. 2018 Jun 4;11(1):348. doi: 10.1186/s13104-018-3458-7.
PubMed 29866200
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Physical Performance Battery in COPD - Possible Impact of a Pulmonary Rehabilitation Program and Relationships to Other Physical Performance Measures, Symptoms, and Quality of Life.
- ClinicalTrials.gov ID
- NCT02314338
- Acronym / sponsor ID
- REK2014/1499
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Karolinska Institutet
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Dec 2014 (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.
Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. SPPB has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. The investigators would like to evaluate possible changes in the SPPB score after a 4-week rehabilitation program. The investigators would also like to look at possible relationships between the SPPB and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitationMulti-disciplinary pulmonary rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with all stages of COPD
- Decision making capacity to provide informed written consent
- Ability to understand and complete the questionnaires
Key exclusion criteria (4 listed)
- Exacerbation within the last four weeks
- Co-morbidities that limits the patient's physical performance more than COPD
- Any patient whom is deemed unsafe to exercise
- Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)
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 rehabilitationIn-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team | Other | Pulmonary rehabilitation |
Primary outcome
Short physical performance battery (SPPB)
Time frame: Pre and posttest with 4 weeks in between
SPPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.
9 secondary outcomes
Lung function
Time frame: 4 weeks
6-minute walk test (6MWT)
Time frame: 4 weeks
Borg category ratio-10 scale (Borg CR-10 scale)
Time frame: 4 weeks
Peripheral oxygenation level
Time frame: 4 weeks
Bilateral leg press 1 repetition Maximum (RM)
Time frame: 4 weeks
Modified Medical Research Council Dyspnea Scale (MMRC)
Time frame: 4 weeks
COPD assessment test (CAT)
Time frame: 4 weeks
Hospital anxiety and depression scale (HADS)
Time frame: 4 weeks
Fatigue severity scale (FSS)
Time frame: 4 weeks
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 1 Jan 2016.
- Derived from this study: PubMed 29866200Larsson P, Borge CR, Nygren-Bonnier M, Lerdal A, Edvardsen A. An evaluation of the short physical performance battery following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. BMC Res Notes. 2018 Jun 4;11(1):348. doi: 10.1186/s13104-018-3458-7.
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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.
Anne Edvardsen, PhD principal investigator
LHL-klinikkene Glittre
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 Chronic Obstructive Pulmonary Disease, run by LHL Helse 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 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 1 Jan 2016. 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?
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?
Short physical performance battery (SPPB) (time frame: Pre and posttest with 4 weeks in between). 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 NCT02314338, which also lists 1 linked publication.
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 1 Jan 2016.