Last updated: April 23, 2024
Sponsor: University of Surrey
Overall Status: Active - Recruiting
Phase
N/A
Condition
Leukemia
Chronic Lymphocytic Leukemia
Lymphoproliferative Disorders
Treatment
EXE+ Nutritional Guidance
HIT
Clinical Study ID
NCT06379282
FHMS 21-22 263 EGA
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Confirmed diagnosis of CLL (including small lymphocytic leukaemia) as per theInternational 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
Exclusion Criteria:
- Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mgor less or equivalent is allowed. Topical or inhaled corticosteroids are permitted.
- Secondary malignancy within 3 years of study enrollment requiring intervention exceptfor adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer,carcinoma in situ of the cervix, superficial bladder cancer not treated withintravesical chemotherapy or BCG within 6 months, localised prostate cancer and PSAstable.
- Absolute contraindications to exercise: Recent (<6 months) acute cardiac eventunstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise,symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonaryembolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism andacute systemic infection.
- Significant orthopaedic limitations, musculoskeletal disease and/or injury. Due to thenature of the study, persons with known joint, muscle or other orthopaedic limitationsthat restrict physical activity may be excluded.
- Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronicobstructive pulmonary disease
- Uncontrolled blood pressure (≥180/90) at rest
- Known concurrent HIV, Hepatitis B or Hepatitis C
- Unable to comply with other study requirements
Study Design
Total Participants: 132
Treatment Group(s): 2
Primary Treatment: EXE+ Nutritional Guidance
Phase:
Study Start date:
October 14, 2022
Estimated Completion Date:
August 01, 2026
Study Description
Connect with a study center
University of Surrey
Guildford, GU2 7WG
United KingdomActive - Recruiting
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