Improving Exercise Capacity With a Tailored Physical Activity Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWake Forest University Health Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise with Trainerize application

    Other intervention

    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

    Diagnostic test

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

  • MRI scan

    Diagnostic test

    Images of the heart will be taken.

  • Quality of Life Questionnaires

    Behavioral

    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

    Behavioral

    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

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Physical Activity InterventionExperimental treatment 6 interventions
Group B: Healthy Living Intervention (Control Arm)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in Peak VO2

An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.

Time frame
At baseline and 6 months after study intervention

Secondary outcomes

1

Change in Peak Exercise Cardiac Output

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time frame
At baseline and 6 months after study intervention
2

Change in Calculated A-V Oxygen Levels

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time frame
At baseline and 6 months after study intervention
3

Changes in Measurements of Pre-exercise Left Ventricular Function

Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.

Time frame
At baseline and 6 months after study intervention
4

Change in Neurocognitive Function - Hopkins Verbal Learning Test

The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). This test has three parts and two alternate forms. Total scores could range from 0 to 30. Lower raw scores indicate difficulties with the task.

Time frame
At baseline and 6 months after study intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator