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Non Hodgkin LymphomaPALSNCT05595577

Improving Exercise Capacity With a Tailored Physical Activity Intervention

A study testing Exercise with Trainerize application, Cardiopulmonary exercise testing and MRI scan in people with Non Hodgkin Lymphoma and Heart; Functional Disturbance, run by Wake Forest University Health Sciences at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Exercise with Trainerize application, Cardiopulmonary exercise testing and MRI scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesUnited States
Study dates
1 Mar 2023to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be considered eligible, participants must meet all of the following criteria:
  • Individuals aged 18- 85 years
  • Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer
  • Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab, rituximab]), immuno-therapies (immune checkpoint inhibitors [ICI's]) or radiation (within 8 weeks of completion of radiation).29-31
  • Ability to speak and understand English
  • Capacity to walk at least 2 city blocks (~.2 miles) on a flat surface
  • Expected survival beyond 6 months.
  • Must have an assistant that will help perform the home-based testing activities

Who cannot join

  • If the patient meets any of these criteria they are excluded from the study:
  • Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
  • Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.
  • Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)
  • Pregnant
  • Unstable angina
Show all 12Show fewer
  • Contraindication for exercise training or testing
  • Inability to exercise on a treadmill or stationary cycle
  • Significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty)
  • Atrial fibrillation with uncontrolled ventricular response
  • Acute myocardial infarction within 28 days
  • Inability to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment

The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life.

Participants will be randomized to 1 of 2 pathways:

  • First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment.
  • Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.
Read the detailed description

Primary Objective: To determine if a >10% difference exists in the % change (i.e., 2.06 ml/kg/min difference) in peak VO2 (volume or amount of oxygen your body consume) from baseline to 6 months of intervention between participants receiving the Physical Activity Intervention (PAI) versus Healthy Living Intervention (HLI).

Secondary Objectives:

  • To determine if a >10% difference exists in the % change in peak exercise cardiac output, calculated A-VO2 difference, and pre-exercise measures of left ventricular function from baseline to 6 months of intervention between participants receiving the PAI versus HLI.
  • Among these same participants, 1) to compare PAI and HLI groups on their baseline to 3 \& 6 months after initiating cancer treatment changes in 6-minWD, Health-Related Quality of Life (HRQOL), fatigue, strength, physical activity, cognitive \& physical function, 2) to determine the relationships between the 6-month time-dependent changes in these and peak VO2; and 3) to examine whether time-dependent changes in peak exercise cardiac output and/or calculated arteriovenous oxygen difference are associated with similar time-dependent changes in peak VO2.
  • Assess physical activity engagement via accelerometry.
Being tested
Exercise with Trainerize application, Cardiopulmonary exercise testing, MRI scan, Quality of Life Questionnaires, Cognitive and Brain Function Questionnaires
Keywords
Exercise capability, Brain activity
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease, Breast Neoplasms

What participants receive

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

  • Exercise with Trainerize applicationOther

    1-2 sessions per week consisting of slow 15 minute aerobic warm, 20 minutes of strength training, 15 minutes progressive intensity aerobic exercise and 10 minute cool down (stretching/toning) with elastic bands.

  • Cardiopulmonary exercise testingDiagnostic test

    Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.

  • MRI scanDiagnostic test

    Images of the heart will be taken.

  • Quality of Life QuestionnairesBehavioural

    Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.

  • Cognitive and Brain Function QuestionnairesBehavioural

    Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.

  • Blood drawsOther

    Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath. A portion of blood from each visit will be used to collect information about blood cell count.

Study groups in NCT05595577
Study groupRoleWhat they receive
Physical Activity InterventionExperimentalParticipants will have the ability to attend one to two training sessions per week and 1-2 sessions per week at home (the 4th level of our multi-level intervention) or the location site using the Trainerize application to deliver the exercise prescription.
Receives: Other: Exercise with Trainerize application; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: MRI scan; Behavioral: Quality of Life Questionnaires; Behavioral: Cognitive and Brain Function Questionnaires; Other: Blood draws
Healthy Living Intervention (Control Arm)ExperimentalParticipants randomized to the control arm will participate in organized health workshops. Each session will last 60 minutes and will be offered on location and virtually (e.g., Zoom) over 6 months. Participants will meet once a week for the first 4 weeks, biweekly for 3 months, and once a month for the last 2 months for a total of 12 sessions.
Receives: Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: MRI scan; Behavioral: Quality of Life Questionnaires; Behavioral: Cognitive and Brain Function Questionnaires; Other: Blood draws

What is being measured

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

  1. Change in Peak VO2

    An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.

    Measured: At baseline and 6 months after study intervention

Secondary outcomes (15)
  1. Change in Peak Exercise Cardiac Output

    Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

    Measured: At baseline and 6 months after study intervention

  2. Change in Calculated A-V Oxygen Levels

    Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

    Measured: At baseline and 6 months after study intervention

  3. Changes in Measurements of Pre-exercise Left Ventricular Function

    Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

    Measured: At baseline and 6 months after study intervention

  4. Change in Neurocognitive Function - Hopkins Verbal Learning Test

    The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). This test has three parts and two alternate forms. Total scores could range from 0 to 30. Lower raw scores indicate difficulties with the task.

    Measured: At baseline and 6 months after study intervention

  5. Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)

    The Controlled Oral Word Association Test is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). COWAT is measured by calculating the total number of acceptable words produced for at the given letter of the alphabet. Errors and perseverations (word repetitions) are not included in this score.

    Measured: At baseline and 6 months after study intervention

  6. Change in Neurocognitive Function - Digit Span-Backward Test

    The digit span backward test is used to assess working memory. Participants are given a series of digits and asked to repeat them backward. The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 16 points.

    Measured: At baseline and 6 months after study intervention

  7. Change in Neurocognitive Function - Trail Making Test

    The Trail Making Test (TMT) asks patients to connect consecutive "targets" (numbers and/or letters) on a page arranged in a specific geometric pattern. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better.

    Measured: At baseline and 6 months after study intervention

  8. Change in 6-Minute Walk Distance

    Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

    Measured: At baseline, 3 months and 6 months after study intervention

  9. Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B)

    FACT-Lym is 42-item questionnaire to assess the quality of life for lymphoma patients. 5-point Likert scale - 0 (not at all) to 4 (very much). Subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Lymphoma Subscale. Some items are reverse scored. Subscales scores are added to get the total score. The higher the score, the better the quality of life. Scores can range from 0-168.

    FACT-B is a 37-item Functional Assessment of Cancer Therapy-Breast (FACT-B) that measures five domains of health-related quality of life in breast cancer patients. These include physical, social, emotional and functional well being on a Likert scale 0-4 with (not at all) to 4 (very much). The higher the score, the better quality of life. Scores can range from 0-148.

    Measured: At baseline, 3 months and 6 months after study intervention

  10. Fatigue Questionnaire

    Questionnaire to assess the difference in the level of fatigue participants experience will performing study interventions. 5-point Likert scale - 0 (not at all) to 4 (very much). The higher the score the higher level of fatigue participants experience. Score range 0-52.

    Measured: At baseline, 3 months and 6 months after study intervention

  11. Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire

    The questionnaire is a 4-item measure used to classify participants' activity levels during a typical 7-day period based on how many times on average participants exercise more than 15 minutes during their free time of strenuous, moderate or mild exercise.

    Measured: At baseline, 3 months and 6 months after study intervention

  12. Change in Physical Function - Balance Test

    Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support: heel of one foot beside the big toe of the other foot (semi-tandem position), heel of one foot in front of and touching the toes of the other foot (tandem position), and single leg stand.

    Measured: At baseline, 3 months and 6 months after study intervention

  13. Change in Physical Function - Chair Stand Test

    The repeated chair stand test will be performed using a straight-backed chair placed with its back against a wall. Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.

    Measured: At baseline, 3 months and 6 months after study intervention

  14. Change in Physical Function - 4-Meter Walk Gait Speed Test

    The gait speed test will assess the participant's ability to walk 4 meters. Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their usual speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded

    Measured: At baseline, 3 months and 6 months after study intervention

  15. Change in Physical Function - Grip Strength

    Grip strength will be assessed using an isometric handgrip dynamometer while the participant is seated with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position. The participant should exert maximally and quickly (about 1 second) and two trials should be made alternately with each hand, with at least 30 seconds between trials for the same hand (recorded in kilograms).

    Measured: At baseline, 3 months and 6 months after study intervention

Timeline

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

  1. First posted27 Oct 2022
  2. Study start1 Mar 2023
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595577
Sponsor's protocol ID
IRB00087763
Other IDs
4R33CA226960-03, WFBCCC 98622
Acronym
PALS
Status last verified
Sep 2026
First submitted
20 Oct 2022
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise with Trainerize application, Cardiopulmonary exercise testing and MRI scan in people with Non Hodgkin Lymphoma and Heart; Functional Disturbance, run by Wake Forest University Health Sciences at 2 sites 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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 Peak VO2 (time frame: At baseline and 6 months after study intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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