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

NCT ID: NCT03548857

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-20

Study Completion Date

2020-05-30

Brief Summary

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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

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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

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COPD

Keywords

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Muscle dysfunction Cardiovascular regulation Lung transplantation (LTx)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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Lung transplantation

Single or double lung transplantation in patients with COPD

Intervention Type OTHER

Eligibility Criteria

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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

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Camilla Koch Ryrsø

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrik Winning Iepsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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the Centre for Physical Activity Research, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ulrik Winning Iepsen, MD, PhD

Role: CONTACT

Phone: +4540732842

Email: [email protected]

Camilla Koch Ryrsø, MSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ulrik Winning Iepsen, MD, PhD

Role: primary

Other Identifiers

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H-17039327

Identifier Type: -

Identifier Source: org_study_id