Bronchial Response to Exercise After Double Lung Transplantation

NCT ID: NCT07035743

Last Updated: 2025-06-25

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

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-05

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Airway Response Lung Transplant Recipients Lung Transplant Challenge Test

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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double lung transplant recipients

Exercise

Intervention Type OTHER

5 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing

Exercise

Intervention Type OTHER

15 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing

Interventions

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Exercise

5 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing

Intervention Type OTHER

Exercise

15 minutes of constant workload exercise at 60% of peak oxygen uptake from cardiopulmonary exercise testing

Intervention Type OTHER

Other Intervention Names

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5-minute exercise 15-minute exercise

Eligibility Criteria

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Inclusion Criteria

1. Received double lung transplantation
2. ≥ 3 months post-transplant

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mei-Chun Wan

Role: CONTACT

+886-3-3281200 ext. 2658

Mei-Chun Wan

Role: CONTACT

+886-3-3281200 ext. 2657

Facility Contacts

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Mei-Chun Wan

Role: primary

+886-3-3281200 ext. 2658

Mei-Chun Wan

Role: backup

+886-3-3281200 ext. 2657

References

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Zantah M, Pandya A, Marchetti N, Jacobs MR, Criner GJ. Lung Denervation and Its Effect on Bronchial Responsiveness Following Lung Transplant Surgery2020.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10588625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15797754 (View on PubMed)

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: 10.1164/ajrccm/145.6.1503.

Reference Type BACKGROUND
PMID: 1596027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2140767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2666042 (View on PubMed)

Other Identifiers

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202500344B0

Identifier Type: -

Identifier Source: org_study_id

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