Walking CapacityNCT01915641
CPAP Improves the Walking Capacity in Patients With COPD and OSA
A study testing CPAP in people with Walking Capacity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients. However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Walking Capacity
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Nov 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
- OSA : AHI > 15/h, obstructive type predominant
Who cannot join
- any malignancy
- pregnancy
- claustrophobia
- age<18
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei
About this study
We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients.
However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding.
Read the detailed description
inclusion criteria :
- COPD : FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
- OSA : AHI > 15/h, obstructive type predominant exclusion criteria :
- any malignancy
- pregnancy
- claustrophobia
- age<18 primary outcome : exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
Method : For those fit in criteria. CPAP titration will be performed to determine the optimal pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart rate variability, muscle power and other baseline characteristics Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
- Conditions
- Walking Capacity
- Being tested
- CPAP
- Keywords
- walking capacity, COPD, OSA, CPAP
- 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.
CPAPDevice
Also called continuous positive airway pressure
Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement Receives: Device: CPAP |
| group B | Sham comparator | group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
Measured: CPAP treatment for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walking CapacityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSAI-YU WANG, MD, Principal investigator, Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, TaiwanTSAI-YU WANG, MD, Principal investigator, Department of Thoracic Medicine, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915641
- Sponsor's protocol ID
- 101-5303B
- Status last verified
- Apr 2013
- First submitted
- 28 Jul 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Improves the Walking Capacity in Patients With COPD and OSA
- ClinicalTrials.gov ID
- NCT01915641
- Acronym / sponsor ID
- 101-5303B
- Conditions
- Walking Capacity
- Keywords
- walking capacity, COPD, OSA, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2016 (actual)
- First posted
- 5 Aug 2013 (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.
We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients.
However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding.
Detailed description
inclusion criteria :
- COPD : FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
- OSA : AHI > 15/h, obstructive type predominant exclusion criteria :
- any malignancy
- pregnancy
- claustrophobia
- age<18 primary outcome : exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
Method : For those fit in criteria. CPAP titration will be performed to determine the optimal pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart rate variability, muscle power and other baseline characteristics Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: CPAPgroup A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement |
| group B | Sham comparator | Device: CPAPgroup B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
- OSA : AHI > 15/h, obstructive type predominant
Key exclusion criteria (4 listed)
- any malignancy
- pregnancy
- claustrophobia
- age<18
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 |
|---|---|---|
| CPAPAlso: continuous positive airway pressureRandomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement | Device | group A, group B |
Primary outcome
exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
Time frame: CPAP treatment for 1 month
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 22 Nov 2016.
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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.
TSAI-YU WANG, MD principal investigator
Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan
TSAI-YU WANG, MD principal investigator
Department of Thoracic Medicine, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Walking Capacity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 22 Nov 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 Taiwan. 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?
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?
exercise capacity (walking distance (meter), measured by incremental shuttle walking test) (time frame: CPAP treatment for 1 month). 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 22 Nov 2016.