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Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD) (COPD)

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ClinicalTrials.gov Identifier: NCT03548857
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Camilla Koch Ryrsø, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment
COPD Other: Lung transplantation

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COPD patients
COPD patients on the waiting list for a lung transplantation
Other: Lung transplantation
Single or double lung transplantation in patients with COPD




Primary Outcome Measures :
  1. 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

  2. Change in 6 min walking test [ Time Frame: Change from baseline at 6 months ]
    Exercise capacity

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Change in skeletal muscle function [ Time Frame: Change from baseline at 6 months ]
    Muscle biopsy

  2. Change in blood volume [ Time Frame: Change from baseline at 6 months ]
    CO re-breathing method

  3. Change in capillarization of lung tissue [ Time Frame: Change from baseline at 6 months ]
    Transbronchial biopsy (only COPD patients)


Biospecimen Retention:   Samples With DNA
Blood samples (plasma), muscle biopsies (m. quadriceps femoris), transbronchial biopsy.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
COPD patients on the waiting list for a lung transplantation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548857


Contacts
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Contact: Ulrik Winning Iepsen, MD, PhD +4540732842 ulrik_winning@hotmail.com
Contact: Camilla Koch Ryrsø, MSc +4531245603 ryrsoe@yahoo.dk

Locations
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Denmark
the Centre for Physical Activity Research, Copenhagen University Hospital Recruiting
Copenhagen, Denmark
Contact: Ulrik Winning Iepsen, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Ulrik Winning Iepsen, MD, PhD Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark

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Responsible Party: Camilla Koch Ryrsø, Principle Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03548857     History of Changes
Other Study ID Numbers: H-17039327
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Camilla Koch Ryrsø, Rigshospitalet, Denmark:
Muscle dysfunction
Cardiovascular regulation
Lung transplantation (LTx)

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases