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Recruiting NCT07035743

Bronchial Response to Exercise After Double Lung Transplantation

Observational Airway Response Lung Transplant Recipients Lung Transplant Challenge Test

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, Exercise.
Who it may be relevant to
Registry conditions: Airway Response, Lung Transplant Recipients, Lung Transplant, Challenge Test. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to investigate the airway response to exercise and its association with breathlessness in double lung transplant recipients by comparing responses during 5-minute and 15-minute exercise durations.

Detailed description

Participants will undergo a constant workload challenge set at 60% of their peak oxygen uptake in 2 separate sessions: a 5-minute and a 15-minute exercise session, conducted in a random order. Ratings of perceived exertion will be measured every 5 minutes during exercise. Forced expiratory volume in 1 second will be performed before exercise, immediately post-exercise, and at 5, 10, 15, 20, and 30 minutes post-exercise in order to assess the airway response.

Interventions

  • Other Exercise
    5 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing
  • Other Exercise
    15 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing

Primary outcome measures

  • Percentage change in FEV1 from baseline [Time frame: from enrollment to up to 12 weeks]

Eligibility criteria

Inclusion criteria

  • Received double lung transplantation
  • ≥ 3 months post-transplant

Exclusion criteria

  • Diagnosis of asthma
  • Significant airflow limitation (≤50% FEV1 predicted)
  • Inability to cooperate with the required tests and measurements
  • Recent infection or rejection within 1 month
  • Exercise contraindication (e.g., recent heart attack or stroke within 3 months, uncontrolled hypertension, known aortic aneurysm, unstable cardiac ischemia, malignant arrhythmias)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital, Linkou Branch — Taoyuan

Publications

  • Zantah M, Pandya A, Marchetti N, Jacobs MR, Criner GJ. Lung Denervation and Its Effect on Bronchial Responsiveness Following Lung Transplant Surgery2020.
  • Stanbrook MB, Kesten S. Bronchial hyperreactivity after lung transplantation predicts early bronchiolitis obliterans. Am J Respir Crit Care Med. 1999 Dec;160(6):2034-9. doi: 10.1164/ajrccm.160.6.9801037. PMID 10588625
  • Reid DW, Walters EH, Johns DP, Ward C, Burns GP, Liakakos P, Williams TJ, Snell GI. Bronchial hyperresponsiveness and the bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2005 Apr;24(4):489-92. doi: 10.1016/j.healun.2004.02.006. PMID 15797754
  • Herve P, Picard N, Le Roy Ladurie M, Silbert D, Cerrina J, Le Roy Ladurie F, Chapelier A, Dartevelle P, Simonneau G, Parquin F, et al. Lack of bronchial hyperresponsiveness to methacholine and to isocapnic dry air hyperventilation in heart/lung and double-lung transplant recipients with normal lung histology. The Paris-Sud Lung Transplant Group. Am Rev Respir Dis. 1992 Jun;145(6):1503-5. doi: 10.1 PMID 1596027
  • Glanville AR, Theodore J, Baldwin JC, Robin ED. Bronchial responsiveness after human heart-lung transplantation. Chest. 1990 Jun;97(6):1360-6. doi: 10.1378/chest.97.6.1360. PMID 2140767
  • Glanville AR, Gabb GM, Theodore J, Robin ED. Bronchial responsiveness to exercise after human cardiopulmonary transplantation. Chest. 1989 Aug;96(2):281-6. doi: 10.1378/chest.96.2.281. PMID 2666042

Identifiers

NCT: NCT07035743 · 202500344B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗