Clinical trial NCT06396611: Exercise As Intervention in Chronic Lymphocytic Leukemia
Official title: Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Keywords: Strength Training
Physical Activity
Chronic Lymphocytic Leukemia
Vigorous Physical Activity
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

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.

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

Primary outcomes:
measure: Change in VO2 peak as measured by cardiopulmonary exercise test
timeFrame: Baseline to 16-weeks
measure: Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test
timeFrame: Baseline to 16-weeks
measure: Change in muscular strength (grip force in kg) as measured by dynamometer exercise test
timeFrame: Baseline to 16-weeks
measure: Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
timeFrame: Baseline to 16-weeks
measure: Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)
timeFrame: Baseline to 16-weeks
measure: Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)
timeFrame: Baseline to 16-weeks
Secondary outcomes:
measure: Change in Health Related Quality of Life as measured by FACIT-F questionnaire
timeFrame: Baseline to 16-weeks
measure: Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires
timeFrame: Baseline to 16-weeks
measure: Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days
timeFrame: Baseline to 16-weeks
measure: Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection
timeFrame: Baseline to 16-weeks
measure: Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection
timeFrame: Baseline to 16-weeks
measure: Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection
timeFrame: Baseline to 16-weeks
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Sport of University of Porto
Study officials:
affiliation: Faculty of Sport of University of Porto
name: Pedro MP Cunha, MSc.
role: PRINCIPAL_INVESTIGATOR
References: