Exercise As Intervention in Chronic Lymphocytic Leukemia

Last updated: March 13, 2025
Sponsor: Universidade do Porto
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lymphocytic Leukemia, Chronic

Leukemia

Chronic Lymphocytic Leukemia

Treatment

Exercise Training as Intervention

Clinical Study ID

NCT06396611
CLL_FADEUP
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 11
Treatment Group(s): 1
Primary Treatment: Exercise Training as Intervention
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Faculty of Sport of University of Porto

    Porto, 4200-450
    Portugal

    Site Not Available

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