Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Universidade do Porto
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 16-weeks
JAMAR Hand Grip for Upper Body Evaluation
Change in VO2 peak as measured by cardiopulmonary exercise test
Time Frame: 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)
Time Frame: Baseline to 16-weeks
DEXA Test for Whole Body Composition
Secondary Outcomes
- Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection(Baseline to 16-weeks)
- Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires(Baseline to 16-weeks)
- Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days(Baseline to 16-weeks)
- Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection(Baseline to 16-weeks)
- Change in Health Related Quality of Life as measured by FACIT-F questionnaire(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(Baseline to 16-weeks)