PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with Chronic Lymphocytic Leukemia (CLL). DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a maximal cycle ergometer test, 2) Body Composition, 3) Muscle strength, 4) physical activity levels, 5) blood measures (e.g. immune and inflammatory functions). DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging. HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers.
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with CLL and without any prior treatment. DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a Cardiopulmonary Exercise Test with Electrocardiogram (CPET+ECG) maximal cycle ergometer test, 2) a dual-energy X-ray absorptiometry (DEXA) Body Composition test, 3) a Muscle strength test with dynamometry, 4) a characterization of physical activity (PA) levels with accelerometry, and 5) blood measures (e.g. immune and inflammatory functions). The REx group will undertake a strength-based type of training with intensities near 80% of 1-Repetition Maximum (1-RM), with individual supervision (personal training approach). DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging. HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers. It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
Supervised Exercise Training as an Intervention using Resistance Training.
Faculty of Sport of University of Porto
Porto, Porto District, Portugal
Change in VO2 peak as measured by cardiopulmonary exercise test
Cardio metabolic CPET + Stress ECG
Time frame: Baseline to 16-weeks
Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test
BIODEX Concentric/Concentric Strength Test for Lower Body evaluation
Time frame: Baseline to 16-weeks
Change in muscular strength (grip force in kg) as measured by dynamometer exercise test
JAMAR Hand Grip for Upper Body Evaluation
Time frame: Baseline to 16-weeks
Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
1 Repetition Maximum For Strength Evaluation of Whole Body
Time frame: Baseline to 16-weeks
Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)
DEXA Test for Whole Body Composition
Time frame: Baseline to 16-weeks
Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)
DEXA Test for Bone Mineral Density
Time frame: Baseline to 16-weeks
Change in Health Related Quality of Life as measured by FACIT-F questionnaire
Questionnaire The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), a 40-item measure that assesses self-reported fatigue.
Time frame: Baseline to 16-weeks
Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires
Questionnaire from EORTC Quality of Life Group (EORTC QLQ-C30) a 30-item instrument designed to measure quality of life in all cancer patients, with the supplement of CLL17 a 17-item instrument designed to measure quality of life in chronic lymphocytic leukemia patients
Time frame: Baseline to 16-weeks
Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days
GT9XLink accelerometer from Actigraph to collect data of the Physical Activity patterns, over a period of seven consecutive days, with a minimum of 10 hours of daily assessment
Time frame: Baseline to 16-weeks
Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Time frame: Baseline to 16-weeks
Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Time frame: Baseline to 16-weeks
Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Time frame: Baseline to 16-weeks
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