Exercise As Intervention in Chronic Lymphocytic Leukemia
NCT ID: NCT06396611
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
11 participants
INTERVENTIONAL
2023-09-01
2025-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
We also expect to follow up those patients, after the intervention protocol terminus, using routine consultation on participating Hospitals, and acquiring data to support the long-term effects of the protocol. The follow-up will maintain the Onco-Hematology consultations routine and periodicity (6 months after last medical appointment), where all initial assessments will be undertaken.
TREATMENT
TRIPLE
Study Groups
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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.
Exercise Training as Intervention
Supervised Exercise Training as an Intervention using Resistance Training.
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.
No interventions assigned to this group
Interventions
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Exercise Training as Intervention
Supervised Exercise Training as an Intervention using Resistance Training.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Universidade do Porto
OTHER
Responsible Party
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Principal Investigators
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Pedro MP Cunha, MSc.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Sport of University of Porto
Locations
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Faculty of Sport of University of Porto
Porto, Porto District, Portugal
Countries
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Other Identifiers
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CLL_FADEUP
Identifier Type: -
Identifier Source: org_study_id
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