Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06654206

Effects of a Strength Physical Exercise Program in Chronic Lymphocytic Leukemia Patients

Chronic lymphocytic leukemia (CLL) is a hematological neoplasm that primarily affects older individuals and is the most common type of leukemia in adults in Western countries. CLL mainly affects older adults, with an average age at diagnosis of around 70 years, and there is a slightly higher risk in men compared to women. It is characterized by the proliferation of clonal B lymphocytes in peripheral blood, bone marrow, and lymphoid organs. Although CLL has a relatively slow progression in many cases, patients may experience chronic fatigue, muscle weakness, functional impairment, and psychological disorders, such as anxiety and depression, which significantly affect their quality of life.

In this context, it has been shown that physical exercise, especially strength training, can considerably improve physical and psychological conditions in oncology populations, such as those with breast cancer and colorectal cancer, as well as in older adults, where the benefits of resistance training are widely recognized. These benefits include increased muscle strength, reduced fatigue, improved functional abilities, psychological well-being, and overall quality of life. Furthermore, there is evidence that exercise can reduce systemic inflammatory markers, such as C-reactive protein (CRP), and improve lipid profiles by lowering total cholesterol and triglycerides, which is crucial for cancer patients at risk of cardiovascular diseases.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Lymphocytic Leukemia Behavior Chronic Disease Disease Attributes Exercise 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

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

Current research on the effects of physical exercise in patients with CLL is limited. While some studies suggest that cancer patients may benefit from physical exercise, most research has focused on other types of cancer, such as breast, lung, or colorectal cancer. In the case of patients with CLL, in addition to functional and psychological issues, they often experience chronic inflammation and alterations in lipid profiles, which can increase the risk of cardiovascular comorbidities.

Inflammatory markers, such as C-reactive protein (CRP) and pro-inflammatory cytokines (IL-6, TNF-α), are common in patients with CLL, and it has been suggested that modulating these markers through exercise may help control systemic inflammation. Strength training, in particular, could be beneficial for improving the inflammatory and lipid profiles in these patients, although this has not been thoroughly evaluated in this population.

Regarding mental health, studies have reported that patients with CLL experience high levels of anxiety and depression, which significantly deteriorate their quality of life. In other oncology populations, exercise has proven effective in reducing these symptoms and improving overall well-being. However, it has not been sufficiently studied whether these effects can be replicated in patients with CLL, representing a gap in the current literature.

Finally, the loss of muscle strength, a key indicator in the diagnosis of sarcopenia according to the diagnostic algorithm proposed by the European Working Group on Sarcopenia in Older People in 2019 (EWGSOP2), should be considered another common issue in patients with CLL, due to both the average age of the patients (70 years) and the disease itself or the side effects of treatment. Although it has been shown that physical exercise in general, and strength exercise in particular, can improve muscle strength and functional capacity in older adults and cancer patients, studies evaluating these effects in patients with CLL are lacking. Assessing how a strength training program can influence functional recovery and improve the quality of life of these patients is crucial for their clinical management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants diagnosed with CLL or Small Lymphocytic Lymphoma (SLL) undergoing active treatment.
  • Participants who have not engaged in regular physical activity in the past 8 weeks.
  • Performance Status (ECOG) 0-1.
  • Signed informed consent.

Exclusion criteria

  • The presence of any medical contraindications to physical exercise, such as severe musculoskeletal disorders, serious cardiovascular diseases, bone metastases, or other conditions as determined by a healthcare professional.
  • Participants unable to complete the initial evaluation tests or who have difficulty performing basic exercises.
  • Other circumstances, as determined by the researchers, that may interfere with the study's objectives or development.

Participants will be discontinued if they meet any of the following:

  • Negative developments or progression of the tumor process.
  • Severe adverse events related to exercise.
  • Voluntary withdrawal from the intervention.
  • New medical contraindications that prevent safe participation.
  • Non-adherence to the intervention protocol that compromises study integrity.

Treatment and study plan

Exercise

Other

Supervised strength exercise sessions: There will be two sessions per week, each lasting 50 minutes. Each session will consist of three distinct parts:

Warm-up: 10 minutes of global strength and aerobic exercises at 6/10 on the Rating Perceived Exertion (RPE) scale.

Strength training: 6 strength exercises targeting the major muscle groups, lasting 30 minutes. The initial load will be set at 70% of the estimated 1-RM (assessed in the first session and based on the individual patient). When the participant is able to complete 3 sets of 12 repetitions with the established weight in two consecutive sessions, the weight will be increased by 10%. The exercises will be performed in a circuit format with 30 seconds of rest between exercises and 90 seconds of rest between sets.

Cool-down/stretching: 10 minutes of a combination of breathing exercises and stretching for the major muscle groups.

Promotion of physical activity: Participants

Home exercise

Other

Participants will complete three weekly home training sessions that will not coincide with supervised training days. Each session will last 20 minutes, they will complete two sets of five exercises, with one minute of work and one minute of rest.

Primary outcomes

  1. Frailty

    Time frame: 8 weeks

    Frailty will be assessed using the Short Physical Performance Battery (SPPB) scale, which includes three components: a balance test, gait speed, and a chair stand test. The scale has a maximum score of 12 points, with higher scores reflecting better physical function.

Secondary outcomes

  1. Quality of life

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Quality of life assessment: This will be conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). It is a general quality of life instrument for cancer patients. This questionnaire consists of 30 items, 24 of which are grouped into five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and one global health status scale. The remaining six items assess five symptoms (dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and economic impact. A high score on the functional scale indicates greater functional capacity, while a high score on the symptom scale indicates greater distress.

  2. Anxiety and depression

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Anxiety and depression assessment: These will be evaluated using the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable and valid questionnaire, consisting of seven questions (rated from 0 to 3) related to anxiety (subscale A) and another seven related to depression (subscale D), thus providing two separate scores.

  3. Fatigue

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Fatigue assessment: This will be measured using the 13-item subscale of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). The FACT-F is a self-report questionnaire specifically designed to measure the degree of fatigue experienced by individuals with cancer and is the most widely used. It consists of 27 items in the general FACT section and an additional 13 items in the fatigue subscale, with scores ranging from 0 to 160. Higher scores on this scale indicate lower levels of fatigue.

  4. Sleep quality

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Sleep quality assessment: The evaluation of insomnia will be conducted using the Athens Insomnia Scale. It consists of 8 items that assess sleep induction, awakenings during the night, early awakenings, duration, sleep quality, and daytime functioning. The response system is Likert-type, ranging from 0 (absence of the problem) to 3 (serious problem), and the overall score on the scale varies from 0 to 24 points.

  5. Muscle strength

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    The strength of both the lower and upper limbs will be assessed.The Jamar® dynamometer (J00105 Lafayette Instrument Company, USA), a hydraulic dynamometer considered the gold standard in the evaluation of grip strength, will be used. Both hands will be measured. The measurement will be performed following the Southampton Protocol. The patient will be seated in a chair with a backrest and the test will be explained to them. Three consecutive measurements will be taken on the same hand with a duration of 5 seconds per contraction and with an interval of 10 seconds between measurements. Encouraging commands will be given during the test to squeeze harder. The patient shall be seated in a chair with backrest, shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position and wrist in slight extension (0°-30°). The second Jamar® position shall be selected for all participants, with the exception of small hands which shall be placed in the first position.

  6. Body composition

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Body composition assessment: The body mass index (BMI), appendicular lean mass (ALM), and estimated muscle mass will be calculated. This will be performed using electrical bioimpedance, which estimates muscle mass based on the electrical conductivity of the whole body. The TANITA BC-418 Body Composition Analyzer will be used.

  7. Physical activity level

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Physical activity level assessment: This will be determined using the validated IPAQ-e questionnaire for older adults.

  8. Physical performance

    Time frame: 8 weeks

    In addition to the SPPB, walking speed is assessed as a measure of physical performance associated with frailty using the four-meter walk test (4MWT). The patient starts walking one meter before the start line, where the stopwatch is activated, and is instructed to maintain his or her usual speed until four meters past the finish line. The test is performed three times, and the best value is recorded

  9. Blood biomarker

    Time frame: From enrollment to the end of the treatment, 8 weeks.

    Blood biomarker assessment: A blood sample will be taken prior to the start of the exercise program and another within two weeks after its completion. Data from blood samples included in routine clinical practice will be collected to obtain lipid profile values. Additionally, a proteomic analysis of the samples will be conducted at the Cancer Research Center (Molecular and Cellular Biology of Cancer Institute - Laboratory 11 of Dr. Manuel Fuentes García).

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Martín-Sánchez, PhD

CONTACT

[email protected]

646774655

Juan Luis Sanchez-Gonzalez, PhD

CONTACT

[email protected]

646774655

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • Colegio Profesional de Fisioterapeutas de Castilla y León

Registry information

Official study title

Effects of a Strength Physical Exercise Program in Chronic Lymphocytic Leukemia Patients on Quality of Life, Mental Health, and Frailty.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Feb 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.