NCT05595577 Improving Exercise Capacity With a Tailored Physical Activity Intervention
| NCT ID | NCT05595577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Non Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-03-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
William Hundley, MD
PRINCIPAL INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05595577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Non Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05595577 currently recruiting?
Yes, NCT05595577 is actively recruiting participants. Contact the research team at johnkc22@wfu.edu for enrollment information.
Where is the NCT05595577 trial being conducted?
This trial is being conducted at Winston-Salem, United States, Richmond, United States.
Who is sponsoring the NCT05595577 clinical trial?
NCT05595577 is sponsored by Wake Forest University Health Sciences. The principal investigator is William Hundley, MD at Wake Forest Baptist Comprehensive Cancer Center. The trial plans to enroll 110 participants.