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PURPOSE: The purpose of the study is to determine the effects of 12-weeks of exercise training on physical reserve, as measured by aerobic capacity, strength and physical function, in patients with CLL. Further, it is our aim to assess relationships with changes in physical reserve and resilience to the patient's cancer, as measured by immune cell counts, tumor cell killing and antibacterial functions.
DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 12-week control (no supervised exercise) or an intervention (HIIT) group. Before and after the 12 week program subjects will undergo several tests including: 1) a maximal treadmill test, 2) body composition, 3) muscle strength and endurance, 4) physical activity levels, 5) blood measures (e.g. immune and inflammatory functions). Subjects in the HIIT group will complete a 12-week supervised exercise training program consisting of HIIT and strength training.
DATA ANALYSES & SAFETY ISSUES: This is a pilot study, with the goal of assessing whether exercise training causes a change in aerobic fitness (VO2peak), muscle function, and immunological measures. Vo2peak will be measured by a cardiopulmonary exercise test, muscle function will be measured by strength tests, and immunological functions will be measured from blood samples. For outcomes, group change differences from baseline to 12-weeks will be compared by ANCOVA. The data will be used to provide power calculations for future grant proposals. High Intensity Interval Training is a very safe exercise modality. The regular use of vigorous intensity exercise intervals have been used extensively in exercise training. In fact, the exercise intervals will start at levels lower and will be of shorter duration than were used during the maximal exercise test. They will then be carefully and slowly made to be more challenging as each subject is able to safely tolerate.
HYPOTHESIS: The investigators hypothesize that HIIT will be a feasible exercise intervention for people with CLL and will result in improvements in markers of health and fitness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLL-EX | Experimental | Subjects will undergo supervised exercise training 3 x per week for 12 weeks. Three/sessions per week will consist of intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes. Following this, on 2 occasions/week subjects will complete muscular endurance resistance training on machine weights. |
|
| CLL-CON | No Intervention | Subjects will not receive supervised exercise training and will be asked to maintain their daily lifestyle behaviors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Behavioral | Supervised exercise training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in VO2peak as measured by cardiopulmonary exercise test | Baseline to 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lymphocyte doubling rate (LDR) as measured by blood test | Baseline to 12-weeks | |
| Change in muscle strength as measured by a strength test | Strength test is the estimated maximal amount of weight a subject can lift |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bartlett, PhD | Duke University | Principal Investigator |
| Andrea Sitlinger, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36096873 | Derived | Artese AL, Sitlinger A, MacDonald G, Deal MA, Hanson ED, Pieper CF, Weinberg JB, Brander DM, Bartlett DB. Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. J Geriatr Oncol. 2023 Jan;14(1):101373. doi: 10.1016/j.jgo.2022.09.002. Epub 2022 Sep 9. | |
| 34848750 |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Baseline to 12-weeks |
| Change in muscle endurance as measured by a muscle endurance test | Endurance test is the amount of times a subject can lift 70% of maximal muscle strength | Baseline to 12-weeks |
| Change in neutrophil to lymphocyte ratio (NLR) as measured by blood test | Baseline to 12-weeks |
| Change in lymphocyte to monocyte ratio (LMR) as measured by blood test | Baseline to 12-weeks |
| Change in natural killer cell killing of tumor cell lines as measured by flow cytometry | Baseline to 12-weeks |
| Change in neutrophil killing of E.coli as measured by flow cytometry | Baseline to 12-weeks |
| MacDonald G, Sitlinger A, Deal MA, Hanson ED, Ferraro S, Pieper CF, Weinberg JB, Brander DM, Bartlett DB. A pilot study of high-intensity interval training in older adults with treatment naive chronic lymphocytic leukemia. Sci Rep. 2021 Nov 30;11(1):23137. doi: 10.1038/s41598-021-02352-6. |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |