Improving Exercise Capacity With a Tailored Physical Activity Intervention

Recruiting now · Not applicable

Conditions studied: Non Hodgkin Lymphoma, Heart; Functional Disturbance, Hodgkin Lymphoma, Quality of Life, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

In brief

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.

Key facts

Study ID

NCT05595577

Run by

Wake Forest University Health Sciences

People needed

110

Starts

2023-03-01

Expected to finish

2026-08-31

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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