Indagine sul ruolo della modifica del bilancio energetico sulle risposte sanitarie nella leucemia linfocitica cronica (HIT-CLL)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Guildford, Regno Unito, GU2 7WG
- University of Surrey
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: HIT Group
Exercise Only
|
Exercise training only |
|
Sperimentale: EXE+ Group
Exercise + Nutritional Guidance
|
Exercise Training + Nutritional Guidance |
|
Nessun intervento: Control Group
Control group will receive no exercise or nutritional guidance |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
Lasso di tempo: Baseline and 12 weeks
|
A blood sample will be taken and assessed for CD19+/CD5+ CLL frequency using flow cytometry and total lymphocyte counts to determine the absolute number of CLL cells in x10^9/L |
Baseline and 12 weeks
|
|
Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
Lasso di tempo: Baseline and 12 weeks
|
Cardiopulmonary exercise testing will be conducted to assess changes in fitness |
Baseline and 12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Frailty
Lasso di tempo: Baseline and 12 weeks
|
Frailty will be determined by a series of validated physical function tests that provide a score of 0-1(Robust), 2 (Pre-Frail), 3-5 (Frail) |
Baseline and 12 weeks
|
|
Muscle Strength and Endurance
Lasso di tempo: Baseline and 12 weeks
|
Estimated one repetition maximum and repetitions to failure using machine-based weights |
Baseline and 12 weeks
|
|
Muscle Health
Lasso di tempo: Baseline and 12 weeks
|
Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage |
Baseline and 12 weeks
|
|
Change in Quality of Life using the EORCT-QLQ-C30
Lasso di tempo: Baseline and 12 weeks
|
Quality of life will be determined by the EORCT-QLQ-C30 questionnaire |
Baseline and 12 weeks
|
|
Change in muscle oxygen metabolism during a single bout of exercise
Lasso di tempo: Baseline and 12 weeks
|
Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise |
Baseline and 12 weeks
|
|
Change in B-CLL Cell Function
Lasso di tempo: Baseline and 12 weeks
|
Measurement of in vitro B-CLL cell proliferation by flow cytometry |
Baseline and 12 weeks
|
|
Change in systemic and cellular bioenergetics
Lasso di tempo: Baseline and 12 weeks
|
Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry |
Baseline and 12 weeks
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test
Lasso di tempo: 12 weeks to 24 weeks
|
Reassessment of CRF following 12 weeks of unguided exercise training |
12 weeks to 24 weeks
|
|
Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells
Lasso di tempo: 12 weeks to 24 weeks
|
Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training |
12 weeks to 24 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: David Bartlett, PhD, University of Surrey
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Leucemia, linfoide
- Leucemia
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Fragilità
- Neoplasie
- Leucemia, linfocitica, cronica, cellule B
Altri numeri di identificazione dello studio
- FHMS 21-22 263 EGA
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