Actively Recruiting
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Led by University of Surrey · Updated on 2024-04-24
132
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Surrey
Lead Sponsor
A
American Society of Hematology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how exercise training and diet affect physical fitness, immune function, and metabolism in adults with chronic lymphocytic leukemia (CLL). This randomized controlled trial aims to understand the physiological and immunological changes that occur in people with CLL when they participate in exercise or exercise combined with nutritional guidance compared to no exercise. The study is sponsored by the University of Surrey and focuses on adults diagnosed with CLL. Participants will be randomly assigned to one of three groups for 12 weeks: an exercise-only group performing three sessions per week of aerobic and resistance exercises; an exercise-plus-nutritional guidance group that includes the same exercise schedule plus dietary assessment and healthy eating advice; or a control group receiving no exercise or nutritional guidance. Blood samples and physical fitness assessments will be collected at the start and after 12 weeks to measure changes in CLL cell counts, immune function, inflammation, metabolism, and physical fitness. During the study, participants will undergo fitness tests and provide fasting blood samples at baseline and after 12 weeks to evaluate their physiological reserve and immune response. A follow-up visit 12 weeks post-intervention will assess lasting effects on health markers. Researchers will monitor cardiorespiratory fitness, muscle strength and endurance, frailty, quality of life, and cellular function. The total participation time includes the 12-week intervention and a post-study assessment to evaluate ongoing impacts on health.
CONDITIONS
Brief Title
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic leukaemia as per International Workshop on CLL Guidelines
- Male or female aged 18 years or older
- Able to walk on a treadmill or cycle on an ergometer
- Pass the Physical Activity Readiness Questionnaires (PAR-Q and PAR-Q+)
You will not qualify if you...
- Started corticosteroid therapy less than 7 days before study entry; prednisone 10mg or less or equivalent allowed; topical or inhaled corticosteroids permitted
- Secondary malignancy within 3 years requiring intervention, except certain treated skin, cervical, bladder, or prostate cancers
- Absolute contraindications to exercise including recent acute cardiac events, unstable angina, uncontrolled arrhythmias, symptomatic aortic stenosis or heart failure, acute pulmonary embolus, myocarditis, pericarditis, dissecting aneurism, or acute systemic infection
- Significant orthopedic limitations or musculoskeletal disease/injury restricting physical activity
- 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 infection
- Unable to comply with other study requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are randomly assigned to one of three groups: exercise-only, exercise plus nutritional guidance, or no exercise control. Those in the exercise groups participate in 3 sessions per week of aerobic and resistance exercises for 12 weeks, with the exercise plus nutritional guidance group also receiving dietary assessments and guidance.
3 exercise sessions per week; 1 baseline visit and 1 follow-up visit for assessments
Duration - 12 weeks
Participants return 12 weeks after completing the intervention to assess lasting effects of the program on physiological and blood-based health biomarkers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Surrey
Guildford, United Kingdom, GU2 7WG
Actively Recruiting
Research Team
D
David Bartlett, PhD
E
Ellie Miles
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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