AzTrials
AzTrials

Chronic Lymphocytic LeukemiaEarly Phase 1NCT06654206

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

A Early Phase 1 study testing Exercise and Home exercise in people with Chronic Lymphocytic Leukemia and Exercise, run by University of Salamanca.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Lymphocytic Leukemia, Exercise
What is being tested?
Exercise and Home exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
10 Mar 2025to 31 Dec 2025
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Voluntary withdrawal from the intervention.
  • New medical contraindications that prevent safe participation.
  • Non-adherence to the intervention protocol that compromises study integrity.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Carlos Martín-Sánchez, PhD contact

646774655

carlos_ms@usal.es

Juan Luis Sanchez-Gonzalez, PhD contact

646774655

juanluissanchez@usal.es

About this study

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

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.

Read the detailed description

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.

Being tested
Exercise, Home exercise
Keywords
Exercise, Resistance, Chronic Lymphocytic Leukemia, Physiotherapy
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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 exerciseOther

    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.

Study groups in NCT06654206
Study groupRoleWhat they receive
Intervention Group (Therapeutic Strength Exercise Program):ExperimentalThe 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.
Receives: Other: Exercise
Control Group (CG), group without an exercise programActive comparatorPatients 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.
Receives: Other: Home exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. Physical activity level

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

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

  8. 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

    Measured: 8 weeks

  9. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study start10 Mar 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a double-blind, randomized controlled clinical trial with two parallel groups, in which patients diagnosed with Chronic Lymphocytic Leukemia (CLL) and undergoing active treatment will be recruited. Study participants will be assigned to one of two arms of the study: 1) Supervised Therapeutic Strength Exercise Intervention Group (GI); 2) Control Group without Supervised Exercise (GC). The study will last for 3 months. There will be 2 evaluation visits: one prior to the intervention (initial visit) and one at the end of the intervention (final visit). The intervention period will last for 8 weeks. The trial will be conducted following the CONSORT (Consolidated Standards of Reporting Trials) guidelines, and the current treatment protocol is described according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06654206
Sponsor's protocol ID
21102024
Status last verified
Feb 2025
First submitted
21 Oct 2024
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Brown JC, Spielmann G, Yang S, Compton SLE, Jones LW, Irwin ML, Ligibel JA, Meyerhardt JA. Effects of exercise or metformin on myokine concentrations in patients with breast and colorectal cancer: A phase II multi-centre factorial randomized trial. J Cachexia Sarcopenia Muscle. 2024 Aug;15(4):1520-1527. doi: 10.1002/jcsm.13509. Epub 2024 Jun 18.

    PubMed 38887915

  • Sanchez-Gonzalez JL, Fernandez-Rodriguez EJ, Mendez-Sanchez R, Polo-Ferrero L, Puente-Gonzalez AS, de Ramon C, Marcos-Asensio S, Blazquez-Benito P, Navarro-Bailon A, Sanchez-Guijo F, Martin-Sanchez C. Effects of a strength physical exercise program in chronic lymphocytic leukemia patients on quality of life, mental health, and frailty: a randomized controlled trial study protocol. Front Sports Act Living. 2025 Mar 10;7:1534861. doi: 10.3389/fspor.2025.1534861. eCollection 2025.

    PubMed 40129522

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Exercise and Home exercise in people with Chronic Lymphocytic Leukemia and Exercise, run by University of Salamanca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlos Martín-Sánchez, PhD (646774655, carlos_ms@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06654206, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in