Respiratory Strength Training in Heart Transplant Recipients

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06190171
Status
Recruiting
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Conditions

  • Dysphagia
  • Heart Transplant Recipients

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Active respiratory muscle strength training — BEHAVIORAL
    Devices will be set to 60% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).
  • Sham respiratory muscle strength training — BEHAVIORAL
    Springs will be removed from devices to ensure training is done without resistance. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory sham muscle strength training (a total of 50 repetitions).

Study Details

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

Key Dates

Start date
May 17, 2024
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Active respiratory muscle strength training
    Enrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant.
  • Sham Comparator: Sham respiratory muscle strength training
    Enrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials.

Primary Outcome Measure

Change in maximum expiratory pressure between pre and post respiratory strength training [ Time Frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Cara Donohue
[email protected]
615-852-5085
Jill Cable
[email protected]
615-852-5085

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Vanderbilt University Medical Center· Nashville, TN

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