NCT03548857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

May 9, 2018

Last Update Submit

December 24, 2019

Conditions

COPD

Keywords

Muscle dysfunctionCardiovascular regulationLung transplantation (LTx)

Outcome Measures

Primary Outcomes (4)

  • 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

  • Change in 6 min walking test

    Exercise capacity

    Change from baseline at 6 months

  • 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

  • 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 Outcomes (3)

  • Change in skeletal muscle function

    Change from baseline at 6 months

  • Change in blood volume

    Change from baseline at 6 months

  • Change in capillarization of lung tissue

    Change from baseline at 6 months

Study Arms (1)

COPD patients

COPD patients on the waiting list for a lung transplantation

Other: Lung transplantation

Interventions

Lung transplantationOTHER

Single or double lung transplantation in patients with COPD

COPD patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients on the waiting list for a lung transplantation

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Centre for Physical Activity Research, Copenhagen University Hospital

Copenhagen, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (plasma), muscle biopsies (m. quadriceps femoris), transbronchial biopsy.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Ulrik Winning Iepsen, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrik Winning Iepsen, MD, PhD

CONTACT

+4540732842ulrik_winning@hotmail.com

Camilla Koch Ryrsø, MSc

CONTACT

ryrsoe@yahoo.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 7, 2018

Study Start

August 20, 2018

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

DK(1)