Exercise As Intervention in Chronic Lymphocytic Leukemia (ADRENALINE)

Universidade do Porto

Status: Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Treatments: Behavioral: Exercise Training as Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06396611

CLL_FADEUP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Resistance Exercise Training

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Training as Intervention

Conventional Care (Control Group)

No Intervention group

Description:

Control group patients received advice to follow their habitual physical activity routines and are contacted bimonthly to ensure participant retention in the study.