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HIT-CLLNCT06379282

Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Eligibility criteria expanded, about 12 words Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Trial status changed: Unknown → Active, Not Recruiting
    • Study completion pushed from Aug 1, 2026 to Aug 1, 2030
    • Site details revised
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Minor Trial status: Recruiting to Unknown
    • Secondary endpoints revised (7)
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
Timeframe: Baseline and 12 weeks
Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
Timeframe: Baseline and 12 weeks

Secondary (7)

Frailty
Muscle Strength and Endurance
Muscle Health
Change in Quality of Life using the EORCT-QLQ-C30
Change in muscle oxygen metabolism during a single bout of exercise
Show 2 moreShow less
Change in B-CLL Cell Function
Change in systemic and cellular bioenergetics

Arms and interventions

HIT GroupExperimental

Exercise Only * 3 sessions per week * Aerobic + Resistance Exercises

EXE+ GroupExperimental

Exercise + Nutritional Guidance * 3 sessions per week * Aerobic + Resistance Exercises * Dietary assessment at baseline and during with guidance on eating a healthy diet provided

Control GroupNo intervention

Control group will receive no exercise or nutritional guidance

Behavioral: HIT, EXE+ Nutritional Guidance

Sites

1 site in 1 country

  • University of SurreyGuildford, United Kingdom