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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
132
Exercise training only
Exercise Training + Nutritional Guidance
University of Surrey
Guildford, United Kingdom
RECRUITINGChange 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
Time frame: 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
Time frame: Baseline and 12 weeks
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)
Time frame: Baseline and 12 weeks
Muscle Strength and Endurance
Estimated one repetition maximum and repetitions to failure using machine-based weights
Time frame: Baseline and 12 weeks
Muscle Health
Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change in B-CLL Cell Function
Measurement of in vitro B-CLL cell proliferation by flow cytometry
Time frame: 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
Time frame: Baseline and 12 weeks
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