COPDCOPDNCT03548857
Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate changes in the quadriceps muscle and cardiovascular regulation during exercise in relation to improved lung function after lung transplantation in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Lung transplantation
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2018to 30 May 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients on the waiting list for a lung transplantation
Who may be able to join
- COPD with or without alpha 1-antitrypsin deficiency on the waiting list for a lung transplantation
- Single or double lung transplantation
- ≥ 18 years
- Ability to give informed consent
Who cannot join
- Retransplantation
- Multiple-organ transplantation (heart-lung transplantation)
- Musculoskeletal disorders which substantially inhibits physical activity
- Need for crossmatching in connection with lung transplantation
- Anticoagulant therapy before lung transplantation (except acetylsalicylic acid)
Trial locations and contacts
1 site in 1 country.
Camilla Koch Ryrsø, MSc contact
Denmark1 site, 1 recruiting
- Recruiting
the Centre for Physical Activity Research, Copenhagen University Hospital
Copenhagen
Ulrik Winning Iepsen, MD, PhD
About this study
The purpose of the project is to investigate changes in the quadriceps muscle and cardiovascular regulation during exercise in relation to improved lung function after lung transplantation in patients with COPD.
Read the detailed description
Dysfunctional skeletal musculature of the lower limbs is related to low quality of life, exercise intolerance and higher mortality in patients with COPD. Limb muscle dysfunction in COPD consists of muscle atrophy and reduced muscle strength but also intra-muscular alterations in oxidative capacity and mitochondrial function are often present. Moreover, reduced blood flow to exercising muscle may also contribute to the muscle dysfunction in COPD. The mechanisms responsible for muscle dysfunction in COPD patients remain unclear but could be a consequence of reduced lung function, inflammation, medications or low physical activity. Loss of lung function with COPD is normally irreversible so the transition to near-normal lung function after lung transplantation is a unique model to investigate the adaptation of the limb muscle to improved lung function. Thus, the purpose of this project is to investigate the effect of lung transplantation on limb muscle function (mitochondrial function, oxidative enzyme capacity, fiber type distribution, oxygen delivery/uptake) and daily physical activity level in patients with COPD. The project has a translational focus on muscle dysfunction in COPD and uses methodologies from clinical medicine, integrative physiology and molecular biochemistry in order to gain knowledge of mechanisms behind limb muscle dysfunction and exercise intolerance in COPD.
- Conditions
- COPD
- Being tested
- Lung transplantation
- Keywords
- Muscle dysfunction, Cardiovascular regulation, Lung transplantation (LTx)
- 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.
Lung transplantationOther
Single or double lung transplantation in patients with COPD
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | COPD patients on the waiting list for a lung transplantation Receives: Other: Lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leg blood flow (mL/min)
Endothelium function will be evaluated during acute exercise (one legged kicking) by Flow doppler
Measured: Change from baseline at 6 months
Change in 6 min walking test
Exercise capacity
Measured: Change from baseline at 6 months
Change in health-related quality of life
Health-related quality of life will be assessed by total mean score of St. George's Respiratory Questionnaire (SGRQ) (2 parts,3 components questionnaire). Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units are considered clinically relevant.
Measured: Change from baseline at 6 months
Change in health-related quality of life
Health-related quality of life will be assessed by mean score of a validated Danish version of the COPD Assessment Test (CAT). The CAT is a short 8-item questionnaire with scoring range of 0-40, where higher scores indicating more limitations. A change of 2 units suggests a meaningful difference.
Measured: Change from baseline at 6 months
Secondary outcomes (3)
Change in skeletal muscle function
Muscle biopsy
Measured: Change from baseline at 6 months
Change in blood volume
CO re-breathing method
Measured: Change from baseline at 6 months
Change in capillarization of lung tissue
Transbronchial biopsy (only COPD patients)
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start20 Aug 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion30 May 2020 (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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Koch Ryrsø, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrik Winning Iepsen, MD, PhD, Principal investigator, Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548857
- Sponsor's protocol ID
- H-17039327
- Acronym
- COPD
- Status last verified
- Dec 2019
- First submitted
- 9 May 2018
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03548857
- Acronym / sponsor ID
- COPD / H-17039327
- Conditions
- COPD
- Keywords
- Muscle dysfunction, Cardiovascular regulation, Lung transplantation (LTx)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 7 Jun 2018 (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 purpose of the project is to investigate changes in the quadriceps muscle and cardiovascular regulation during exercise in relation to improved lung function after lung transplantation in patients with COPD.
Detailed description
Dysfunctional skeletal musculature of the lower limbs is related to low quality of life, exercise intolerance and higher mortality in patients with COPD. Limb muscle dysfunction in COPD consists of muscle atrophy and reduced muscle strength but also intra-muscular alterations in oxidative capacity and mitochondrial function are often present. Moreover, reduced blood flow to exercising muscle may also contribute to the muscle dysfunction in COPD. The mechanisms responsible for muscle dysfunction in COPD patients remain unclear but could be a consequence of reduced lung function, inflammation, medications or low physical activity. Loss of lung function with COPD is normally irreversible so the transition to near-normal lung function after lung transplantation is a unique model to investigate the adaptation of the limb muscle to improved lung function. Thus, the purpose of this project is to investigate the effect of lung transplantation on limb muscle function (mitochondrial function, oxidative enzyme capacity, fiber type distribution, oxygen delivery/uptake) and daily physical activity level in patients with COPD. The project has a translational focus on muscle dysfunction in COPD and uses methodologies from clinical medicine, integrative physiology and molecular biochemistry in order to gain knowledge of mechanisms behind limb muscle dysfunction and exercise intolerance in COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Lung transplantationCOPD patients on the waiting list for a lung transplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients on the waiting list for a lung transplantation
Key inclusion criteria (4 listed)
- COPD with or without alpha 1-antitrypsin deficiency on the waiting list for a lung transplantation
- Single or double lung transplantation
- ≥ 18 years
- Ability to give informed consent
Key exclusion criteria (5 listed)
- Retransplantation
- Multiple-organ transplantation (heart-lung transplantation)
- Musculoskeletal disorders which substantially inhibits physical activity
- Need for crossmatching in connection with lung transplantation
- Anticoagulant therapy before lung transplantation (except acetylsalicylic acid)
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 |
|---|---|---|
| Lung transplantationSingle or double lung transplantation in patients with COPD | Other | COPD patients |
Primary outcome
Change in leg blood flow (mL/min)
Time frame: Change from baseline at 6 months
Endothelium function will be evaluated during acute exercise (one legged kicking) by Flow doppler
Change in 6 min walking test
Time frame: Change from baseline at 6 months
Exercise capacity
Change in health-related quality of life
Time frame: Change from baseline at 6 months
Health-related quality of life will be assessed by total mean score of St. George's Respiratory Questionnaire (SGRQ) (2 parts,3 components questionnaire). Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units are considered clinically relevant.
Change in health-related quality of life
Time frame: Change from baseline at 6 months
Health-related quality of life will be assessed by mean score of a validated Danish version of the COPD Assessment Test (CAT). The CAT is a short 8-item questionnaire with scoring range of 0-40, where higher scores indicating more limitations. A change of 2 units suggests a meaningful difference.
3 secondary outcomes
Change in skeletal muscle function
Time frame: Change from baseline at 6 months
Change in blood volume
Time frame: Change from baseline at 6 months
Change in capillarization of lung tissue
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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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.
Camilla Koch Ryrsø, MSc contact
Ulrik Winning Iepsen, MD, PhD principal investigator
Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 5 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 26 Dec 2019. 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 Denmark. 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?
Contact Ulrik Winning Iepsen, MD, PhD (+4540732842, ulrik_winning@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in leg blood flow (mL/min) (time frame: Change from baseline at 6 months). The study lists 4 primary outcomes in all. 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 26 Dec 2019.