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

NCT ID: NCT03548857

Last Updated: 2019-12-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2020-05-30

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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

COPD patients on the waiting list for a lung transplantation

Lung transplantation

Intervention Type: OTHER

Single or double lung transplantation in patients with COPD

Interventions

Lung transplantation

Single or double lung transplantation in patients with COPD

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Camilla Koch Ryrsø

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrik Winning Iepsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark

Locations

the Centre for Physical Activity Research, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ulrik Winning Iepsen, MD, PhD

Role: CONTACT

ulrik_winning@hotmail.com

+4540732842

Camilla Koch Ryrsø, MSc

Role: CONTACT

ryrsoe@yahoo.dk

Facility Contacts

Ulrik Winning Iepsen, MD, PhD

Role: primary

Other Identifiers

H-17039327

Identifier Type: -

Identifier Source: org_study_id