An Early Phase 1 interventional study of Exercise and Home exercise in Chronic Lymphocytic Leukemia and Exercise, sponsored by University of Salamanca. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University of Salamanca · Early Phase 1, Interventional, and Treatment
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.
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.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
This study's planned enrollment of 40 is close to the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.
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Exclusion Criteria
Participants will be discontinued if they meet any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The therapeutic strength exercise program focused on strength exercises, although daily aerobic exercises were also included. The intervention group will participate in a supervised therapeutic strength exercise program twice a week, combined with a physical activity promotion program to be conducted at home three days a week. All supervised strength exercise sessions will be led by a physiotherapist in a physiotherapy clinic with appropriate space for the intervention.
Other: Exercise
Patients in the control group (CG) will only participate in the physical activity promotion program five days a week. This will be combined with walking for 60 minutes every day of the week.
Other: Home exercise
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
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.
Frailty
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.
Time frame: 8 weeks
Quality of life
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Anxiety and depression
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Fatigue
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Sleep quality
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Muscle strength
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Body composition
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.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Physical activity level
Physical activity level assessment: This will be determined using the validated IPAQ-e questionnaire for older adults.
Time frame: From enrollment to the end of the treatment, 8 weeks.
Physical performance
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
Time frame: 8 weeks
Blood biomarker
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).
Time frame: From enrollment to the end of the treatment, 8 weeks.
No study locations are listed for this record.
Plan to share: Yes — Further enquiries can be directed to the corresponding author. All the data collected in the study will be shared. Individual deidentified participant data are available. Additional and related documents such as study protocol or statistical analysis are available. The data will be available from April 2025 and for as long as necessary. The data will always be shared with the approval of the corresponding author analyzing the purpose which they are going to be used.
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 2 years. From April 2025.
Access criteria: Internet
Start is estimated for Mar 2025; primary completion for Dec 2025, 9 months later.
Of 96 non-industry phase 1 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 91. This study's planned 9 months is below that.
Counting every sponsor, half of 180 studies reached it within 56 months; a quarter within 39 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell →