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

COPD Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548857
• Other study ID #: H-17039327
• Status: Recruiting
• Start date: August 20, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2019
• Source: Rigshospitalet, Denmark
• Contact: Ulrik Winning Iepsen, MD, PhD
• Phone: +4540732842
• Email: ulrik_winning[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Lung transplantation
Single or double lung transplantation in patients with COPD

Locations

Country	Name	City	State
Denmark	the Centre for Physical Activity Research, Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in leg blood flow (mL/min)	Endothelium function will be evaluated during acute exercise (one legged kicking) by Flow doppler	Change from baseline at 6 months
Primary	Change in 6 min walking test	Exercise capacity	Change from baseline at 6 months
Primary	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.	Change from baseline at 6 months
Primary	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.	Change from baseline at 6 months
Secondary	Change in skeletal muscle function	Muscle biopsy	Change from baseline at 6 months
Secondary	Change in blood volume	CO re-breathing method	Change from baseline at 6 months
Secondary	Change in capillarization of lung tissue	Transbronchial biopsy (only COPD patients)	Change from baseline at 6 months