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| Name | Class |
|---|---|
| American Society of Hematology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIT Group | Experimental | Exercise Only
|
|
| EXE+ Group | Experimental | Exercise + Nutritional Guidance
|
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| Control Group | No Intervention | Control group will receive no exercise or nutritional guidance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIT | Behavioral | Exercise training only |
| |
| EXE+ Nutritional Guidance |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 | 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 |
| Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12 | Cardiopulmonary exercise testing will be conducted to assess changes in fitness | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frailty | 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 |
| Muscle Strength and Endurance |
| Measure | Description | Time Frame |
|---|---|---|
| Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test | Reassessment of CRF following 12 weeks of unguided exercise training | 12 weeks to 24 weeks |
| Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Bartlett, PhD | Contact | 01483 683 245 | d.bartlett@surrey.ac.uk | |
| Ellie Miles | Contact | 01483 688 559 | e.e.miles@surrey.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David Bartlett, PhD | University of Surrey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Surrey | Recruiting | Guildford | GU2 7WG | United Kingdom |
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Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
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| Behavioral |
Exercise Training + Nutritional Guidance |
|
Estimated one repetition maximum and repetitions to failure using machine-based weights
| Baseline and 12 weeks |
| Muscle Health | Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage | Baseline and 12 weeks |
| Change in Quality of Life using the EORCT-QLQ-C30 | Quality of life will be determined by the EORCT-QLQ-C30 questionnaire | Baseline and 12 weeks |
| Change in muscle oxygen metabolism during a single bout of exercise | Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise | Baseline and 12 weeks |
| Change in B-CLL Cell Function | Measurement of in vitro B-CLL cell proliferation by flow cytometry | Baseline and 12 weeks |
| Change in systemic and cellular bioenergetics | Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry | Baseline and 12 weeks |
Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training |
| 12 weeks to 24 weeks |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000073496 | Frailty |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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