Recruiting

Exercise

Sponsor:

Mayo Clinic

Code:

NCT05876923

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Indolent Non-hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Cardiopulmonary Exercise Testing

Dual X-ray Absorptiometry

Electronic Health Record Review

Exercise Intervention

Study Details

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 indolent non-Hodgkin lymphoma (NHL) and 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 indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Indolent Non-hodgkin Lymphoma

Study ID

NCT05876923

Start date

Jun 12, 2023

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English speaking
  • Between the ages of 18-80
  • Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) 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
  • Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

active comparator: Aims 3-4 arm I (indolent NHL usual care)

Indolent NHL patients 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. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients receive usual care on study.

active comparator: Aims 3-4 arm II (indolent NHL aerobic based training program)

Indolent NHL patients 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. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

experimental: Aim 5 (repeat baseline activities)

All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

Interventions

Biospecimen Collection

Undergo collection of blood

Cardiopulmonary Exercise Testing

Undergo CPET

Dual X-ray Absorptiometry

Undergo DEXA scan

Electronic Health Record Review

Ancillary studies

Exercise Intervention

Undergo aerobic based training program

Physical Examination

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Ancillary studies

Spirometry

Undergo spirometry

Physical Performance Testing

Undergo muscular strength and functional endurance measurements

Best Practice

Receive usual care

Primary outcome measure

  • Assess circulating immune cell abundance and function pre-intervention [ Time Frame: Baseline ]
  • Assess circulating immune cell mobilization and function post-intervention [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Courtney Wheatley-Guy, PhD

480-301-8976wheatley.courtney@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Jordan Parks

480-301-6616parks.jordan@mayo.edu

Principal Investigator:

Michael P. Gustafson, PhD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Briana Ziegler

507-255-7125zeigler.briana@mayo.edu

Principal Investigator:

Neil E. Kay, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-09.