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Active, Not Recruiting

NCT Number: NCT06396611

Exercise As Intervention in Chronic Lymphocytic Leukemia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Lymphocytic Leukemia Behavior Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport of University of Porto

Porto, Porto District, 4200-450, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training as Intervention

Behavioral

Supervised Exercise Training as an Intervention using Resistance Training.

Primary outcomes

  1. Change in VO2 peak as measured by cardiopulmonary exercise test

    Time frame: Baseline to 16-weeks

    Cardio metabolic CPET + Stress ECG

  2. Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test

    Time frame: Baseline to 16-weeks

    BIODEX Concentric/Concentric Strength Test for Lower Body evaluation

  3. Change in muscular strength (grip force in kg) as measured by dynamometer exercise test

    Time frame: Baseline to 16-weeks

    JAMAR Hand Grip for Upper Body Evaluation

  4. Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test

    Time frame: Baseline to 16-weeks

    1 Repetition Maximum For Strength Evaluation of Whole Body

  5. Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)

    Time frame: Baseline to 16-weeks

    DEXA Test for Whole Body Composition

  6. Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)

    Time frame: Baseline to 16-weeks

    DEXA Test for Bone Mineral Density

Secondary outcomes

  1. Change in Health Related Quality of Life as measured by FACIT-F questionnaire

    Time frame: Baseline to 16-weeks

    Questionnaire The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), a 40-item measure that assesses self-reported fatigue.

  2. Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires

    Time frame: Baseline to 16-weeks

    Questionnaire from EORTC Quality of Life Group (EORTC QLQ-C30) a 30-item instrument designed to measure quality of life in all cancer patients, with the supplement of CLL17 a 17-item instrument designed to measure quality of life in chronic lymphocytic leukemia patients

  3. Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days

    Time frame: Baseline to 16-weeks

    GT9XLink accelerometer from Actigraph to collect data of the Physical Activity patterns, over a period of seven consecutive days, with a minimum of 10 hours of daily assessment

  4. Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection

    Time frame: Baseline to 16-weeks

    Peripheral Blood Collection during Hospital Consultation

  5. Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection

    Time frame: Baseline to 16-weeks

    Peripheral Blood Collection during Hospital Consultation

  6. Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection

    Time frame: Baseline to 16-weeks

    Peripheral Blood Collection during Hospital Consultation

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia

Acronym: ADRENALINE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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