NCT07035743

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 25, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

June 10, 2025

Last Update Submit

June 16, 2025

Conditions

Airway ResponseLung Transplant RecipientsLung TransplantChallenge Test

Keywords

airway responsedouble lung transplantationexercise challenge testdyspneabreathlessness

Outcome Measures

Primary Outcomes (1)

  • Percentage change in FEV1 from baseline

    Percentage change in FEV1 from baseline at immediately post-exercise, 5, 10, 15, 20, and 30 minutes post-exercise.

    from enrollment to up to 12 weeks

Study Arms (1)

double lung transplant recipients

Other: Exercise

Interventions

ExerciseOTHER

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

Also known as: 5-minute exercise
double lung transplant recipients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

double lung transplantation recipients

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, 33305, Taiwan

RECRUITING

Related Publications (6)

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

    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.

    PMID: 10588625BACKGROUND

  • 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: 15797754BACKGROUND

  • 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.

    PMID: 1596027BACKGROUND

  • 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: 2140767BACKGROUND

  • 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: 2666042BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mei-Chun Wan

CONTACT

+886-3-3281200alliewan@cgmh.org.tw

Mei-Chun Wan

CONTACT

+886-3-3281200r10428001@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 25, 2025

Study Start

June 5, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)