The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients
Study Details
Study Description
Brief Summary
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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Determine how circulating immune cell abundance and function (via cell counts & cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
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Determine how circulating immune cell mobilization and function (cell counts & cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.
OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2.
AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing [CPET]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.
AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aim 1 (vitals, spirometry, CPET, blood samples, DEXA) Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. |
Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
Other: Cardiopulmonary Exercise Testing
Undergo CPET
Other Names:
Procedure: Dual X-ray Absorptiometry
Undergo DEXA scan
Other Names:
Other: Electronic Health Record Review
Ancillary studies
Procedure: Physical Examination
Undergo measurement of height/weight and vital signs
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Spirometry
Undergo spirometry
|
| Experimental: Aim 2 (aerobic based training program, Aim 1 activities) CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program. |
Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
Other: Cardiopulmonary Exercise Testing
Undergo CPET
Other Names:
Procedure: Dual X-ray Absorptiometry
Undergo DEXA scan
Other Names:
Other: Electronic Health Record Review
Ancillary studies
Other: Exercise Intervention
Undergo aerobic based training program
Procedure: Physical Examination
Undergo measurement of height/weight and vital signs
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Spirometry
Undergo spirometry
|
Outcome Measures
Primary Outcome Measures
- Assess circulating immune cell abundance and function pre-intervention [Baseline]
A standardized questionnaire will be administered to assess levels of past and current physical activity. Baseline measurement of pulmonary function (PFT) will be collected and possibly a body composition scan via dual x-ray absorptiometry (DEXA). While subjects perform cardiopulmonary exercise testing (CPET), cardiopulmonary vitals will be assessed and monitored throughout exercise and in recovery. A 40 mL venous blood sample will be drawn at baseline and post exercise (80 mL total), along with finger prick measures of blood lactate at rest and early recovery. Blood samples will be evaluated to determine how circulating immune cell abundance and function (via cell counts & cytokine profile) of chronic lymphocytic leukemia (CLL) patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
- Assess circulating immune cell mobilization and function post-intervention [Up to 12 weeks]
Each subject will participate in a 12-weeks exercise program (3 times per week) at a moderate to high exercise intensity level based upon the results of their cardiopulmonary exercise testing (CPET)]. Upon completion of the program, subjects will return to the laboratory for post testing using the same techniques as used during the baseline. Venous blood samples drawn at rest after the program will be used to determine how circulating immune cell mobilization and function (cell counts and cytokine profile) of CLL patients respond to intervention. Usual descriptive statistics will be performed - means, standard deviations, and ranges. Comparisons within a group over time or pre/post will be performed using paired t-tests, while comparisons between groups will be performed using unpaired t-tests or where necessary using ANOVA. Comparisons will be made based on absolute values as well as changes during a test.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-80 years of age will participate in this study
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Diagnosis of CLL/SLL (chronic lymphocytic leukemia/small lymphocytic lymphoma) will be required to participate in Aim 2 of this study
Exclusion Criteria:
- Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease [COPD], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Michael P Gustafson, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-012246
- NCI-2023-03210
- 22-012246