At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- HIT (behavioural), EXE+ Nutritional Guidance (behavioural)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- HIT — behavioural: Exercise training only · EXE+ Nutritional Guidance — behavioural: Exercise Training + Nutritional Guidance
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 132
- Started
- 2022-10-14
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • NA - 132 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Guildford - University of Surrey
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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+)
Who cannot take part
- ✗Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mg or less or equivalent is...
- ✗Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronic obstructive lung disease
- ✗Uncontrolled blood pressure (≥180/90) at rest
- ✗Known concurrent HIV, Hepatitis B or Hepatitis C
- ✗Unable to comply with other study requirements
See the full criteria
Where Is This Study? (1 UK site)
University of Surrey
Guildford GU2 7WG, United Kingdom
How to Get in Touch
David Bartlett, PhD
Sponsor contactCONTACT
Ellie Miles
Sponsor contactCONTACT
