Exercise As Intervention in Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Behavioral: Exercise Training as Intervention
- Registration Number
- NCT06396611
- Lead Sponsor
- Universidade do Porto
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 11
- Confirmed diagnosis of CLL as per the International Workshop on CLL Guidelines
- No history of previous treatment of CLL
- Able to walk on a treadmill or cycle ergometer
- Able to carry weights, or use weight machines
- Pass initial evaluations (CPET for cardiac health, Isokinetic for muscular health)
- Willing to adhere to the exercise program
- Signed informed consent
- Previous CLL treatments
- Ongoing engagement in a regular exercise program
- Indication of disease progression and for starting treatment within 6 months
- Other primary tumour
- Inability to perform exercise (Heart disease, advanced stage respiratory, renal, hepatic, neurological, or osteoarticular disease)
- Unable to travel to FADEUP facilities or comply with other study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Resistance Exercise Training Exercise Training as Intervention Patients in the REx program are submitted to resistance machine exercises for the major muscle groups aiming to achieve the intensity of 80% of 1-Repetition Maximum (1-RM). A warmup and cool down of 10 and 5 minutes, respectively, were included in each session aiming workloads of 60%-85% of peak heart rate (HRp). Enrolment through the REx program resistance machines will be conducted from major muscle groups to minor muscle groups, from polyarticular to monoarticular exercises, and alternating between agonist and antagonist contraction according to the following laydown: Leg Press -\> Leg Curl -\> Leg Extension -\> Chest Press -\> Latissimus Pulldown -\> Shoulder Press -\> Triceps Extension -\> Biceps Curl -\> Abdominal Crunch.
- Primary Outcome Measures
Name Time Method Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test Baseline to 16-weeks 1 Repetition Maximum For Strength Evaluation of Whole Body
Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density) Baseline to 16-weeks DEXA Test for Bone Mineral Density
Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test Baseline to 16-weeks BIODEX Concentric/Concentric Strength Test for Lower Body evaluation
Change in muscular strength (grip force in kg) as measured by dynamometer exercise test Baseline to 16-weeks JAMAR Hand Grip for Upper Body Evaluation
Change in VO2 peak as measured by cardiopulmonary exercise test Baseline to 16-weeks Cardio metabolic CPET + Stress ECG
Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass) Baseline to 16-weeks DEXA Test for Whole Body Composition
- Secondary Outcome Measures
Name Time Method Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection Baseline to 16-weeks Peripheral Blood Collection during Hospital Consultation
Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires Baseline to 16-weeks 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
Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days Baseline to 16-weeks 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
Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection Baseline to 16-weeks Peripheral Blood Collection during Hospital Consultation
Change in Health Related Quality of Life as measured by FACIT-F questionnaire Baseline to 16-weeks Questionnaire The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), a 40-item measure that assesses self-reported fatigue.
Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection Baseline to 16-weeks Peripheral Blood Collection during Hospital Consultation
Trial Locations
- Locations (1)
Faculty of Sport of University of Porto
🇵🇹Porto, Portugal