Recruiting

Physical Activity & Education

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05595577

Conditions

Non Hodgkin Lymphoma

Heart; Functional Disturbance

Hodgkin Lymphoma

Quality of Life

Stage I Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise with Trainerize application

Cardiopulmonary exercise testing

MRI scan

Quality of Life Questionnaires

Cognitive and Brain Function Questionnaires

Study Details

Brief 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.

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.

Conditions

Non Hodgkin Lymphoma

Heart; Functional Disturbance

Hodgkin Lymphoma

Quality of Life

Stage I Breast Cancer

Study ID

NCT05595577

Start date

Mar 1, 2023

Status verified date

Feb, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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
  • 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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Physical Activity Intervention

Participants 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.

experimental: Healthy Living Intervention (Control Arm)

Participants 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.

Interventions

Exercise with Trainerize application

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 testing

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

MRI scan

Images of the heart will be taken.

Quality of Life Questionnaires

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 Questionnaires

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 draws

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.

Primary outcome measure

  • Change in Peak VO2 [ Time Frame: At baseline and 6 months after study intervention ]

Central Contacts and Locations

Central contacts

Study Coordinator

336-758-3027johnkc22@wfu.edu

Pamela J. Grizzard

804-628-6234pamela.grizzard@vcuhealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

W G Hundley, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

W. G. Hundley, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 20, 2026

Last verified

Feb, 2026

Keywords

  • Exercise capability
  • Brain activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-20.