To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in change in endurance time measured
by an endurance cycle test between the EBV treatment group and the
bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).
Secondary outcome
Pulmonary rehabilitation
• the difference between the EBV treatment group and the EBV+PR group in change
in:
-Physical activity measured by accelerometry
-Lung function measured by spirometry, bodyplehtysmography and
diffusion capacity
-Exercise capacity measured by an incremental cycle ergometer test and
6-minute walk distance test
-Peripheral muscle strength measured by a leg press test
-Depression severity and anxiety level measured by the HADS and fatigue level
measured by the CIS questionnaire.
• the differences in above mentioned variables between the patients who undergo
PR before EBV treatment versus the patients who undergo PR after EBV treatment.
Patient-reported outcomes
• the change after EBV treatment in depression severity measured by the HADS
questionnaire
• the change after EBV treatment in anxiety level measured by the HADS
questionnaire
• the change after EBV treatment in fatigue level measured by the CIS
questionnaire.
Cardiopulmonary function:
• the change after EBV treatment in RVEDVI as measured with cardiac MRI.
• the change after EBV treatment in cardiac structural, volumetric, and
functional changes of the right ventricle, left ventricle, and left atrium;
local and regional measures of aortic stiffness; pulmonary pulsatility as
measured with cardiac MRI
• the relative contribution of improvement in RVEDVI to the improvement in
exercise capacity or physical activity after EBV treatment.
• the change in RVEDVI as function of actual lobar volume reduction (measured
on CT and Bodyplethysmography).
Metabolism and change in body composition
• the change after EBV treatment in fat-free mass index, fat mass, and fat
distribution measured by a dexa scan.
• the relationship between the change in muscle volume measured on CT scan and
the change in exercise capacity,
• the relationship between the change in muscle volume measured on CT scan and
the change in exercise capacity, change in lung mechanics (measured by HRCT and
bodyplethysmography) and cardiac alteration.
• In muscle and fat biopsies before and after EBV we will perform a detailed
histological and biochemical analysis of muscle fiber type composition,
mitochondrial density, master regulators of muscle oxidative programming,
mitochondrial respiration and lipid droplets.
Background summary
The published clinical trials investigating the bronchoscopic lung volume
reduction, showing important patient-related improvements in efficacy, led to
the acknowledgement of the treatment in the GOLD-COPD2017 guidelines.
Interaction with pulmonary rehabilitation, impact on patient-reported outcomes,
physical activity, and extrapulmonary consequences are all topics to gain more
insight in. This importantly, to further develop and optimize this innovative
and personalized therapy.
Study objective
To study in detail the impact and optimal timing of pulmonary rehabilitation
(PR) on exercise physiology and patient-reported outcomes and the impact of the
bronchoscopic lung volume reduction treatment using endobronchial valves (EBV)
on cardiopulmonary function, metabolism and changes in body composition.
Study design
This study is a randomized controlled trial with 3 study-arms. Group 1 will
first follow a PR program and afterwards undergo the EBV treatment. Group 2
will first undergo the EBV treatment and approximately 8 weeks later will
follow a PR program. Group 3 will only undergo the EBV treatment (and can
choose to follow a PR program after completing the 6 month FU visit).
Intervention
Most patients will undergo a bronchoscopic lung volume reduction treatment
using endobronchial valves and a pulmonary rehabilitation program. One group of
patient will under a bronchoscopic lung volume reduction treatment using
endobronchial valves and can choose whether they also want to follow a
pulmonary rehabilitation program afterwards.
Study burden and risks
This study has no major risks for the participating patients. The patients will
be exposed to additional exercise capacity and physical activity measurements,
3 additional questionnaires, a CT scan of the quadriceps muscle, a DEXA scan
and peripheral blood collection. Furthermore, a subgroup of patients will be
exposed to a cardiac MRI or muscle and fat biopsies. Patient can directly
benefit from the EBV treatment and the pulmonary rehabilitation program.
Indirect benefit might be achieved, because, at a group level we will learn
more about this novel treatment for our severe emphysema patients and will be
able to further optimize this treatment.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- COPD.
- FEV1 <=45%pred AND FEV1/FVC <70%.
- TLC >100%pred AND RV>175%pred.
- CAT >=10.
- >50% emphysema destruction @-910HU.
- >95% complete major fissure measured by quantitative CT analysis.
- Non-smoking >6 months.
- Signed informed consent.
Exclusion criteria
- PaCO2>8.0 kPa, or PaO2<6.0kPa.
- 6-minute walk test <160m.
- Significant chronic bronchitis, bronchiectasis, or other infectious lung
disease.
- 3 or more hospitalizations due to pulmonary infection within last 12 months
before baseline assessments
- Previous lobectomy, LVRS, or lung transplantation.
- LVEF<45% and or RVSP>50mmHg.
- Anticoagulant therapy which cannot be weaned off prior to procedure.
- Patient is significantly immunodeficient.
- Involved in other pulmonary drug studies within 30 days prior to this study.
- Pulmonary nodule which requires intervention
- Any disease or condition that interferes with completion of initial or
follow-up assessments
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03474471 |
| CCMO | NL65304.042.18 |