Exercise As Intervention in Chronic Lymphocytic Leukemia

NCT06396611 | Active Not Recruiting

• 1 other identifier: CLL_FADEUP
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Strength Training; Physical Activity; Chronic Lymphocytic Leukemia; Vigorous Physical Activity

Outcome Measures

Primary Outcomes (6)

• Change in VO2 peak as measured by cardiopulmonary exercise test

  Cardio metabolic CPET + Stress ECG

  Baseline to 16-weeks

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

  BIODEX Concentric/Concentric Strength Test for Lower Body evaluation

  Baseline to 16-weeks

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

  JAMAR Hand Grip for Upper Body Evaluation

  Baseline to 16-weeks

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

  1 Repetition Maximum For Strength Evaluation of Whole Body

  Baseline to 16-weeks

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

  DEXA Test for Whole Body Composition

  Baseline to 16-weeks

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

  DEXA Test for Bone Mineral Density

  Baseline to 16-weeks

Secondary Outcomes (6)

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

  Baseline to 16-weeks

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

  Baseline to 16-weeks

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

  Baseline to 16-weeks

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

  Baseline to 16-weeks

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

  Baseline to 16-weeks

Study Arms (2)

Resistance Exercise Training

EXPERIMENTAL

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.

Behavioral: Exercise Training as Intervention

Conventional Care (Control Group)

NO INTERVENTION

Control group patients received advice to follow their habitual physical activity routines and are contacted bimonthly to ensure participant retention in the study.

Interventions

Exercise Training as Intervention BEHAVIORAL

Supervised Exercise Training as an Intervention using Resistance Training.

Resistance Exercise Training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Sport of University of Porto

Porto, Porto District, 4200-450, Portugal

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Motor Activity

Interventions

Exercise; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• Pedro MP Cunha, MSc.

  Faculty of Sport of University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 2, 2024
• Study Start: September 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)