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NCT04950452 · ClinicalTrials.gov registry record · NA
Exercise Training to Promote Resilience to Chronic Lymphocytic Leukemia
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04950452 is a NA study that has completed, run by Duke University. The registered enrollment target is 20 participants.
The verdict
NCT04950452, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL Exercise Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-08-22 |
| Est. Completion | 2020-01-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04950452
The ClinicalTrials.gov registry entry for NCT04950452 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exercise Training is the first listed.
NCT04950452 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04950452 about?
NCT04950452 is a clinical study titled "Exercise Training to Promote Resilience to Chronic Lymphocytic Leukemia". 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...
What is the current status of trial NCT04950452?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-08-22. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT04950452?
The interventions under investigation include: Exercise Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04950452?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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