Clinical trial NCT03548857: Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: Muscle dysfunction
Cardiovascular regulation
Lung transplantation (LTx)
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients on the waiting list for a lung transplantation

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in leg blood flow (mL/min)
timeFrame: Change from baseline at 6 months
measure: Change in 6 min walking test
timeFrame: Change from baseline at 6 months
measure: Change in health-related quality of life
timeFrame: Change from baseline at 6 months
measure: Change in health-related quality of life
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Change in skeletal muscle function
timeFrame: Change from baseline at 6 months
measure: Change in blood volume
timeFrame: Change from baseline at 6 months
measure: Change in capillarization of lung tissue
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: the Centre for Physical Activity Research, Copenhagen University Hospital
Study officials:
affiliation: Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark
name: Ulrik Winning Iepsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: