Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Clinical evaluation is performed in invited hospitals, physical activity evaluation is performed by the outcomes assessor in Faculty of Sport of University of Porto. The investigator is the person who will conduct the intervention, and he's the one that will know what protocol is assigned to each patient, but without knowing the results from clinical and physical fitness evaluations.
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Resistance Exercise Training
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.
Intervention: Exercise Training as Intervention (Behavioral)
Conventional Care (Control Group)
Control group patients received advice to follow their habitual physical activity routines and are contacted bimonthly to ensure participant retention in the study.
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)