만성 림프구성 백혈병의 건강 반응에 대한 에너지 균형 수정의 역할 조사 (HIT-CLL)
This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.
연구 개요
상세 설명
This study aims to perform a randomised control trial of exercise or exercise plus nutritional guidance on the physiological and immunological health of adults diagnosed with chronic lymphocytic leukaemia (CLL). Recruited participants will be randomised to either 12 weeks of an exercise-only program, an exercise-plus nutritional guidance program or a no-exercise control group. Fasting blood samples collected at Baseline and 12 weeks will measure absolute CLL cell counts, immune function, and inflammatory and metabolic biomarkers. A series of physical fitness assessments will be assessed at baseline and 12 weeks to determine physiologic reserve and resilience against external stressors. Additionally, participants will be asked to return 12 weeks after completing the intervention to assess the legacy effects of the intervention on the same physiological and blood-based biomarkers of health.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Guildford, 영국, GU2 7WG
- University of Surrey
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed diagnosis of CLL (including small lymphocytic leukaemia) as per the International Workshop on CLL Guidelines.
- Male or female ≥ 18 years of age
- Able to walk on a treadmill or cycle on an ergometer
- Pass the Physical Activity Readiness Questionnaires (PAR-Q and PAR-Q+)
Exclusion Criteria:
- Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mg or less or equivalent is allowed. Topical or inhaled corticosteroids are permitted.
- Secondary malignancy within 3 years of study enrollment requiring intervention except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localised prostate cancer and PSA stable.
- Absolute contraindications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
- Significant orthopaedic limitations, musculoskeletal disease and/or injury. Due to the nature of the study, persons with known joint, muscle or other orthopaedic limitations that restrict physical activity may be excluded.
- Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronic obstructive pulmonary disease
- Uncontrolled blood pressure (≥180/90) at rest
- Known concurrent HIV, Hepatitis B or Hepatitis C
- Unable to comply with other study requirements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HIT Group
Exercise Only
|
Exercise training only |
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실험적: EXE+ Group
Exercise + Nutritional Guidance
|
Exercise Training + Nutritional Guidance |
|
간섭 없음: Control Group
Control group will receive no exercise or nutritional guidance |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
기간: Baseline and 12 weeks
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A blood sample will be taken and assessed for CD19+/CD5+ CLL frequency using flow cytometry and total lymphocyte counts to determine the absolute number of CLL cells in x10^9/L |
Baseline and 12 weeks
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Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
기간: Baseline and 12 weeks
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Cardiopulmonary exercise testing will be conducted to assess changes in fitness |
Baseline and 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Frailty
기간: Baseline and 12 weeks
|
Frailty will be determined by a series of validated physical function tests that provide a score of 0-1(Robust), 2 (Pre-Frail), 3-5 (Frail) |
Baseline and 12 weeks
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Muscle Strength and Endurance
기간: Baseline and 12 weeks
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Estimated one repetition maximum and repetitions to failure using machine-based weights |
Baseline and 12 weeks
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Muscle Health
기간: Baseline and 12 weeks
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Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage |
Baseline and 12 weeks
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Change in Quality of Life using the EORCT-QLQ-C30
기간: Baseline and 12 weeks
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Quality of life will be determined by the EORCT-QLQ-C30 questionnaire |
Baseline and 12 weeks
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Change in muscle oxygen metabolism during a single bout of exercise
기간: Baseline and 12 weeks
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Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise |
Baseline and 12 weeks
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Change in B-CLL Cell Function
기간: Baseline and 12 weeks
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Measurement of in vitro B-CLL cell proliferation by flow cytometry |
Baseline and 12 weeks
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Change in systemic and cellular bioenergetics
기간: Baseline and 12 weeks
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Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry |
Baseline and 12 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test
기간: 12 weeks to 24 weeks
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Reassessment of CRF following 12 weeks of unguided exercise training |
12 weeks to 24 weeks
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Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells
기간: 12 weeks to 24 weeks
|
Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training |
12 weeks to 24 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: David Bartlett, PhD, University of Surrey
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FHMS 21-22 263 EGA
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
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