NCT04950452: HIIT-CLL

Exercise Training to Promote Resilience to Chronic Lymphocytic Leukemia

Completed NA Last updated 6 July 2021

What this trial tests

NA trial testing Exercise Training in Aging in 20 participants. Completed in 6 January 2020.

Timeline

22 August 2018

Primary endpoint
6 January 2020

6 January 2020

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	20
Start date	22 August 2018
Primary completion	6 January 2020
Estimated completion	6 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Exercise Training

Conditions studied

• Aging — all drugs for Aging →
• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Duke University

Who can join

18 and older, any sex, with Aging or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A pilot study of high-intensity interval training in older adults with treatment naïve chronic lymphocytic leukemia.
   MacDonald G, Sitlinger A, Deal MA, Hanson ED, et al · · 2021 · cited 25× · PMID 34848750 · DOI 10.1038/s41598-021-02352-6
2. Aging and Age-Related Epigenetic Drift in the Pathogenesis of Leukemia and Lymphomas: New Therapeutic Targets.
   Allegra A, Caserta S, Mirabile G, Gangemi S. · · 2023 · cited 17× · PMID 37830606 · DOI 10.3390/cells12192392
3. Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study.
   Artese AL, Sitlinger A, MacDonald G, Deal MA, et al · · 2023 · cited 7× · PMID 36096873 · DOI 10.1016/j.jgo.2022.09.002