Improving Exercise Capacity With a Tailored Physical Activity Intervention
Recruiting · NCT05595577 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem, North Carolina, United States
- Virginia Commonwealth University - Richmond, Virginia, United States