Trial Title:
Effects of a Strength Physical Exercise Program in Chronic Lymphocytic Leukemia Patients
NCT ID:
NCT06654206
Condition:
Chronic Lymphocytic Leukemia
Exercise
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
Exercise
Resistance
Chronic Lymphocytic Leukemia
Physiotherapy
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Exercise
Description:
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 60% of estimated VO2max,
focusing on the areas that will primarily be worked on during that session.
Strength training: 6 strength exercises targeting the major muscle groups, lasting 30
minutes. The initial load will be set between 40-70% 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
Arm group label:
Control Group (CG), group without an exercise program
Arm group label:
Intervention Group (Therapeutic Strength Exercise Program):
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:
Aquí tienes la traducción al inglés:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
Individuals diagnosed with CLL who are undergoing active treatment. Individuals who have
not engaged in regular physical activity in the past 8 weeks.
Performance Status (ECOG) 0-1. Signed informed consent.
Exclusion Criteria
Presence of any contraindications for physical exercise: severe musculoskeletal diseases,
severe cardiovascular diseases, bone metastases, and other conditions determined by a
healthcare professional.
Patients unable to perform the initial assessment tests or who have difficulties
performing basic exercises.
Patients who must discontinue treatment due to intolerance. Other circumstances at the
discretion of the researchers that may interfere with the objective or development of the
study.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
April 1, 2025
Lead sponsor:
Agency:
University of Salamanca
Agency class:
Other
Collaborator:
Agency:
Colegio Profesional de Fisioterapeutas de Castilla y León
Agency class:
Other
Source:
University of Salamanca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654206
