Improving Exercise Capacity With a Tailored Physical Activity Intervention (PALS)

Wake Forest University (WFU)

Status: Enrolling

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

Treatments: Other: Blood draws; Diagnostic Test: Cardiopulmonary exercise testing; Other: Exercise with Trainerize application; Behavioral: Quality of Life Questionnaires; Behavioral: Cognitive and Brain Function Questionnaires; Diagnostic Test: MRI scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05595577

4R33CA226960-03 (U.S. NIH Grant/Contract)

IRB00087763

WFBCCC 98622 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Physical Activity Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive and Brain Function Questionnaires

Diagnostic Test: MRI scan

Behavioral: Quality of Life Questionnaires

Other: Exercise with Trainerize application

Diagnostic Test: Cardiopulmonary exercise testing

Other: Blood draws

Healthy Living Intervention (Control Arm)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive and Brain Function Questionnaires

Diagnostic Test: MRI scan

Behavioral: Quality of Life Questionnaires

Diagnostic Test: Cardiopulmonary exercise testing

Other: Blood draws