Clinical trial · Interventional
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
NCT06379282CI-TRIAL-00076436HIT-CLLunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Frailty | — | UNRESOLVED | — |
| Immune Function | — | UNRESOLVED | — |
| Lipid Cell; Tumor | — | UNRESOLVED | — |
| Muscle Function | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXE+ Nutritional Guidance | Behavioral | — | UNRESOLVED |
| HIT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- HIT Group
- description
- Exercise Only * 3 sessions per week * Aerobic + Resistance Exercises
- interventionNames
- Behavioral: HIT
- type
- EXPERIMENTAL
- label
- EXE+ Group
- description
- Exercise + Nutritional Guidance * 3 sessions per week * Aerobic + Resistance Exercises * Dietary assessment at baseline and during with guidance on eating a healthy diet provided
- interventionNames
- Behavioral: EXE+ Nutritional Guidance
- type
- NO_INTERVENTION
- label
- Control Group
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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+) Exclusion Criteria: * 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. * 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 * Unable to comply with other study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.