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

NCT06654206 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 21102024
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Lymphocytic Leukemia; Exercise

Keywords

Exercise; Resistance; Chronic Lymphocytic Leukemia; Physiotherapy

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (9)

• Quality of life

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

• Anxiety and depression

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

• Fatigue

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

• Sleep quality

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

• Muscle strength

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

Study Arms (2)

Intervention Group (Therapeutic Strength Exercise Program):

EXPERIMENTAL

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

Control Group (CG), group without an exercise program

ACTIVE COMPARATOR

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

Interventions

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

Intervention Group (Therapeutic Strength Exercise Program):

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.

Control Group (CG), group without an exercise program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead
• Colegio Profesional de Fisioterapeutas de Castilla y León: collaborator

Related Publications (2)

• 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.

  PMID: 38887915 BACKGROUND

• 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.

  PMID: 40129522 DERIVED

MeSH Terms

Conditions

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

Interventions

Exercise

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

Study Officials

• Carlos Martin Sanchez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Martín-Sánchez, PhD

CONTACT

646774655; carlos_ms@usal.es

Juan Luis Sanchez-Gonzalez, PhD

CONTACT

646774655; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this research project, the evaluators will be blinded, as none of them will know which group the participants belong to. Due to the nature of the study, the participants cannot be blinded. Additionally, the statistical analysis will be performed by an independent statistician who will not be aware of the intervention group, and thus will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: March 10, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years. From April 2025.
• Access Criteria: Internet