Exercise as Intervention in Chronic Lymphocytic Leukemia

Trial Title: Exercise as Intervention in Chronic Lymphocytic Leukemia

NCT ID: NCT06396611

Condition: Chronic Lymphocytic Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell

Conditions: Keywords:
Strength Training
Physical Activity
Chronic Lymphocytic Leukemia
Vigorous Physical Activity

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: Eligible patients who fulfil criteria will be randomized into a controlled design (RCT) comparing the effects of 16 weeks intervention program with a maximum of 2 sessions per week ensuring a 24h rest period between similar sessions, for the same aims and muscular groups. All participants are assessed in primary and secondary outcome measures before and after the intervention period. The intervention is designed with: a) Resistance Exercise Training (REX); b) Control Group (CG). 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.

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.

Intervention:

Intervention type: Behavioral
Intervention name: Exercise Training as Intervention
Description: Supervised Exercise Training as an Intervention using Resistance Training.
Arm group label: Resistance Exercise Training

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.

Criteria for 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

Gender: All

Minimum age: 45 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Faculty of Sport of University of Porto

Address:
City: Porto
Zip: 4200-450
Country: Portugal

Status: Recruiting

Contact:
Last name: Pedro MP Cunha, MSc.

Phone: +351912458876
Email: pedrocunha@fade.up.pt

Contact backup:
Last name: José CD Ribeiro, PhD

Phone: +351962375417
Email: jribeiro@fade.up.pt

Start date: September 1, 2023

Completion date: August 31, 2025

Lead sponsor:
Agency: Universidade do Porto
Agency class: Other

Collaborator:
Agency: Research Centre in Physical Activity, Health and Leisure
Agency class: Other

Source: Universidade do Porto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06396611