심장 이식 수혜자의 호흡 근력 훈련
심장 이식 수혜자의 수술 전 호흡 강화 훈련이 수술 후 건강에 미치는 영향
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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study will involve three in-person research evaluations to our lab or in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, and completion of questionnaires. Following the initial research evaluation, individuals will complete daily exercises of active or sham respiratory muscle strength training for several weeks with one telehealth or in-person session per week. The exercises will take 10-15 minutes to complete, and individuals will fill out training logs daily. Prior to transplantation and after completion of the breathing exercises, individuals will undergo a second research evaluation. Then, following surgery, individuals will undergo a third research evaluation and outcomes will be tracked via the electronic health records system.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Cara Donohue, Ph.D.
- 전화번호: 615-852-5085
- 이메일: cara.donohue@vumc.org
연구 장소
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbilt University Medical Center
-
연락하다:
- Cara Donohue
- 전화번호: 615-852-5085
- 이메일: cara.donohue@vumc.org
-
연락하다:
- Jill Cable
- 전화번호: 615-852-5085
- 이메일: irad.lab@vumc.org
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult (18-90 years old)
- Not pregnant
- Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 1-6
- Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient)
- Be willing to undergo testing procedures and complete the exercise training program.
Exclusion Criteria:
- Individual <18 years old, >90 years old
- Pregnant
- No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
- Unwilling or unable to undergo testing procedures and complete the exercise training program.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
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). |
|
가짜 비교기: 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. |
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). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in maximum expiratory pressure between pre and post respiratory strength training
기간: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of respiratory strength while breathing out |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
|
Change in maximum inspiratory pressure between pre and post respiratory strength training
기간: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of respiratory strength while breathing in |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in cough peak expiratory flow between pre and post respiratory strength training
기간: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
A measure of cough strength |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
|
Patient-reported treatment burden
기간: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
Patients will complete the exercise therapy burden questionnaire (ETBQ). Scores on the ETBQ range from 0-100 with higher scores indicating greater burden. |
post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
|
Patient reported swallow function
기간: pre-surgery (baseline), post-surgery
|
Patients will complete the swallowing and eating related fatigue (SERF) questionnaire. Scores on the SERF range from 0-48 with higher scores indicating greater impairment. |
pre-surgery (baseline), post-surgery
|
|
Change in penetration-aspiration scale scores between before and after surgery
기간: pre-surgery (baseline), post-surgery
|
The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score). |
pre-surgery (baseline), post-surgery
|
|
Change in clinical frailty scale score
기간: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
The Clinical Frailty Scale (CFS) is a measure of physical function. Scores on the CFS range from 1-9 with higher scores indicating greater impairment. |
baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Cara Donohue, Ph.D., Vanderbilt University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 232071
- 24CDA1257668 (기타 보조금/기금 번호: American Heart Association)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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