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Undersøgelse af energibalanceændringens rolle på sundhedsreaktioner ved kronisk lymfatisk leukæmi (HIT-CLL)

9. november 2026 opdateret af: David Bartlett, University of Surrey

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

132

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HIT Group

Exercise Only

  • 3 sessions per week
  • Aerobic + Resistance Exercises
Adfærdsmæssigt: HIT

Exercise training only
Eksperimentel: EXE+ Group

Exercise + Nutritional Guidance

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

Exercise Training + Nutritional Guidance
Ingen indgriben: Control Group

Control group will receive no exercise or nutritional guidance

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
Tidsramme: 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
Tidsramme: Baseline and 12 weeks

Cardiopulmonary exercise testing will be conducted to assess changes in fitness
Baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frailty
Tidsramme: 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
Tidsramme: Baseline and 12 weeks

Estimated one repetition maximum and repetitions to failure using machine-based weights
Baseline and 12 weeks
Muscle Health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 12 weeks

Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry
Baseline and 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Surrey

Samarbejdspartnere

American Society of Hematology

Efterforskere

  • Ledende efterforsker: David Bartlett, PhD, University of Surrey

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. oktober 2022

Primær færdiggørelse (Faktiske)

1. august 2025

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

9. februar 2024

Først indsendt, der opfyldte QC-kriterier

22. april 2024

Først opslået (Faktiske)

23. april 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FHMS 21-22 263 EGA

Plan for individuelle deltagerdata (IPD)

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