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

NCT ID: NCT06654206

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-12-31

Brief 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 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.

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.

Conditions

Chronic Lymphocytic Leukemia; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group (Therapeutic Strength Exercise Program):

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

Control Group (CG), group without an exercise program

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.

Group Type: ACTIVE_COMPARATOR

Home exercise

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

Home exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colegio Profesional de Fisioterapeutas de Castilla y León

UNKNOWN

Sponsor Role: collaborator

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

CARLOS MARTIN SANCHEZ

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Martin Sanchez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Central Contacts

Carlos Martín-Sánchez, PhD

Role: CONTACT

carlos_ms@usal.es

646774655

Juan Luis Sanchez-Gonzalez, PhD

Role: CONTACT

juanluissanchez@usal.es

646774655

References

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.

Reference Type: BACKGROUND

PMID: 38887915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40129522 (View on PubMed)

Other Identifiers

21102024

Identifier Type: -

Identifier Source: org_study_id