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Respiratory Strength Training in Heart Transplant Recipients

StatusRecruiting
PhaseNot applicable
Started2024-05-17
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Sep 1, 2026 → Feb 1, 2027
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-09-08
Study Status, Oversight, Arms and Interventions v9
Primary completion pushed: 2026-09-01 → 2027-02-01
Interventions modified
2026-05-01
Study Status v8
Primary completion date2026-04-01→2026-09-01
2025-05-26
2 amendments v6-v7
2 re-verifications since 2025-05-21, no change to tracked fields
2025-04-05
Study Status, Study Description, Outcome Measures v5
Secondary endpointsdetails revised at 2 of 5 entries
Study description-8 characters
This study will involve three in-person research evaluations (two to our lab, oneor in the hospital) that will last 45 minutes- 1 hour and will consist of a scr [...]
2024-05-31
Study Status, Eligibility, Contacts/Locations, Document Section v4
Eligibility criteria-118 characters
[...] for heart transplantation at VUMC with a waitlist status of 31-6 Have a computer, tablet or electronic device with a stabl [...] Criteria: Individual <18 years old, >90 years old Pregnant Individuals undergoing evaluation or active waitlisting for multiorgan transplant or with a waitlist status of 1 or 2 No access to a computer, tablet or electronic device with a [...]
Show 3 earlier versions
2024-05-20
Study Status v3
Start dateestimated 2024-05-20→confirmed 2024-05-17
2024-05-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, Document Section v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-05-01→2024-05-20
Study sites0→1
2024-04-15
Study Status v1
Start date2024-04-01→2024-05-01
2024-01-02
Original filing
This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. Participants will: * undergo tests of breathing, cough, and swallow function * complete questionnaires about the treatment, their swallow function * complete breathing exercises daily
Trial Details
NCT Number NCT06190171
Lead Sponsor Vanderbilt University Medical Center
Conditions Dysphagia, Heart Transplant Recipients
Enrollment 90 participants
Start Date 2024-05-17
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-21