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AgingHIIT-CLLNCT04950452

Exercise Training to Promote Resilience to Chronic Lymphocytic Leukemia

A study testing Exercise Training in people with Aging and Chronic Lymphocytic Leukemia, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aging, Chronic Lymphocytic Leukemia
What is being tested?
Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
22 Aug 2018to 6 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of CLL as per the International Workshop on CLL Guidelines.
  • Male or female ≥ 18 years of age
  • No history of prior treatment of CLL
  • Able to walk on a treadmill or cycle on an ergometer
  • Pass the CPET evaluation of aerobic fitness and cardiac health

Who cannot join

  • Clinical evidence of significant disease progression with first line therapy expected within 6 months
  • Corticosteroid therapy initiated less than 7 days prior to study entry. Prednisone 10mg or less or equivalent is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted.
  • Malignancy within 3 years of study enrollment requiring intervention except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer and PSA stable
  • Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
  • Significant orthopedic limitations, musculoskeletal disease and/or injury. Due to the nature of the study, persons with known joint, muscle or other orthopedic limitations that restrict physical activity may be excluded.
  • Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (HbA1c >7%), or chronic obstructive pulmonary disease
Show all 9Show fewer
  • Uncontrolled blood pressure (≥180/90) at rest during screening and confirmed on repeat manual measurement
  • Unable to travel to fitness center or comply with other study requirements
  • Known concurrent HIV, Hepatitis B or Hepatitis C

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Exercise Training to Promote Resilience to Chronic Lymphocytic Leukemia in Older Adults by Enhancing Physical and Immunological Reserve

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.

Read more

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.

Being tested
Exercise Training
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04950452
Study groupRoleWhat they receive
CLL-EXExperimentalSubjects 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.
Receives: Behavioral: Exercise Training
CLL-CONNo interventionSubjects will not receive supervised exercise training and will be asked to maintain their daily lifestyle behaviors.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VO2peak as measured by cardiopulmonary exercise test

    Measured: Baseline to 12-weeks

Secondary outcomes (7)

  1. Change in lymphocyte doubling rate (LDR) as measured by blood test

    Measured: Baseline to 12-weeks

  2. Change in muscle strength as measured by a strength test

    Strength test is the estimated maximal amount of weight a subject can lift

    Measured: Baseline to 12-weeks

  3. 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

    Measured: Baseline to 12-weeks

  4. Change in neutrophil to lymphocyte ratio (NLR) as measured by blood test

    Measured: Baseline to 12-weeks

  5. Change in lymphocyte to monocyte ratio (LMR) as measured by blood test

    Measured: Baseline to 12-weeks

  6. Change in natural killer cell killing of tumor cell lines as measured by flow cytometry

    Measured: Baseline to 12-weeks

  7. Change in neutrophil killing of E.coli as measured by flow cytometry

    Measured: Baseline to 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start22 Aug 2018
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950452
Sponsor's protocol ID
Pro00094597
Acronym
HIIT-CLL
Status last verified
Jun 2021
First submitted
23 Jun 2021
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36096873

  • 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.

    PubMed 34848750

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training in people with Aging and Chronic Lymphocytic Leukemia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VO2peak as measured by cardiopulmonary exercise test (time frame: Baseline to 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04950452, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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