Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Surrey
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.
Eligibility criteria
Qualifiers
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+)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HIT
- EXE+ Nutritional Guidance
Treatment groups
132 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Surrey
Lead sponsor
American Society of Hematology
Collaborator
Source ClinicalTrials.gov