HIIT-based Exercise Intervention for Improvement of Immunomodulatory, Cardiopulmonary, and Psychosocial Parameters During Maintenance Therapy of Paediatric Acute Lymphoblastic Leukaemia (HEALL) (HEALL)
In this study, the investigators aim to examine the effects of high-intensity interval training (HIIT) on cardiopulmonary fitness and immunological recovery in female ALL survivors who underwent cancer treatment during childhood and adolescence.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Isabelle Schöffl, MD
- 전화번호: 09131-85-33118
- 이메일: isabelle.schoeffl@uk-erlangen.de
연구 연락처 백업
- 이름: Axel Karow, MD
- 전화번호: 09131-85-33118
- 이메일: axel.karow@uk-erlangen.de
연구 장소
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Baveria
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Erlangen, Baveria, 독일, 91054
- University Hospital Erlangen, Department for childhood and adolescence medicine
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연락하다:
- Axel Karow, MD
- 전화번호: 09131-85-33118
- 이메일: axel.karow@uk-erlangen.de
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed acute lymphatic leukemia
- Begin of maintenance therapy
- From 6 to 10 years of age
- Physical ability to participate in HIIT and cardiopulmonary exercise testing
Exclusion Criteria:
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Intervention Group
Total of 6 months of HIIT |
HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored. Treadmill Exercising Test Echocardiography with strain rate imaging Routine Electrocardiography Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml) QoL: Kid-KINDL Multispectral-optoacustic imaging of the calf muscle |
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활성 비교기: Control Group
3 months without intervention followed by 3 months of HIIT |
Treadmill Exercising Test Echocardiography with strain rate imaging Routine Electrocardiography Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml) QoL: Kid-KINDL Multispectral-optoacustic imaging of the calf muscle HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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VO2
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
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Oxygen uptake (VO2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VO2max
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
peak oxygen uptake (VO2max) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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RER
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
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Respiratory exchange ratio (RER) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VT2
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Ventilatory anaerobic threshold (VT2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VCO2
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
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Carbon dioxide output (VCO2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
HR
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart rate (HR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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HRR
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart Rate Reserve (HRR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Breath rate at VAT
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Breath rate at VAT |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
BRR
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Breath rate reserve (BRR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VE
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
minute ventilation (VE) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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O2 Pulse
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
O2 Pulse |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
HRV
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart rate variability (HRV) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Echocardiography
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Myocardial function by echocardiographic strain and strain-rate imaging |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Age
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
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Age in years |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Gender
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Gender |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Weight
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Weight |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Blood pressure
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Blood pressure measurement |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
QoL
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Quality of Life: Kid-KINDL |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Immune reconstitution (IR)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
T-, B- and natural killer cell count and marker expression profiles in FACS Blood sample (5ml) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Oxygenated haemoglobin (HbO₂, MSOT)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
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Oxygenated haemoglobin (HbO₂) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Deoxygenated haemoglobin (HHb, MSOT)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Deoxygenated haemoglobin (HHb) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Total haemoglobin (tHb, MSOT)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Total haemoglobin (tHb) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Tissue oxygen saturation (sO₂, MSOT)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Tissue oxygen saturation (sO₂) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Signal Intensity (SI, MSOT)
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
MSOT signal intensity per region of interest |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
MSOT topogram of perfusion of the m. gastrocnemius
기간: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
MSOT topogram of perfusion of the m. gastrocnemius |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- HEALL
- TPRÄ_25_3_E_KARO (기타 보조금/기금 번호: Bavarian Cancer Research Center (BZKF))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared
IPD 공유 기간
Beginning 9 months and ending 36 months following article publication
IPD 공유 액세스 기준
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:
Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.
The data will be available to researchers who provide a methodologically sound proposal.
The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.
Restrictions may apply due to patient privacy and the General Data Protection Regulation.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .