Trial Title:
Improving Exercise Capacity With a Tailored Physical Activity Intervention
NCT ID:
NCT05595577
Condition:
Non Hodgkin Lymphoma
Heart; Functional Disturbance
Hodgkin Lymphoma
Quality of Life
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Conditions: Official terms:
Lymphoma
Breast Neoplasms
Conditions: Keywords:
Exercise capability
Brain activity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
All images will be processed offline by an image analyst blinded to study group
Intervention:
Intervention type:
Other
Intervention name:
Exercise with Trainerize application
Description:
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.
Arm group label:
Physical Activity Intervention
Intervention type:
Diagnostic Test
Intervention name:
Cardiopulmonary exercise testing
Description:
Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking
test.
Arm group label:
Healthy Living Intervention (Control Arm)
Arm group label:
Physical Activity Intervention
Intervention type:
Diagnostic Test
Intervention name:
MRI scan
Description:
Images of the heart will be taken.
Arm group label:
Healthy Living Intervention (Control Arm)
Arm group label:
Physical Activity Intervention
Intervention type:
Behavioral
Intervention name:
Quality of Life Questionnaires
Description:
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.
Arm group label:
Healthy Living Intervention (Control Arm)
Arm group label:
Physical Activity Intervention
Intervention type:
Behavioral
Intervention name:
Cognitive and Brain Function Questionnaires
Description:
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.
Arm group label:
Healthy Living Intervention (Control Arm)
Arm group label:
Physical Activity Intervention
Intervention type:
Other
Intervention name:
Blood draws
Description:
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.
Arm group label:
Healthy Living Intervention (Control Arm)
Arm group label:
Physical Activity Intervention
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.
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wake Forest Baptist Comprehensive Cancer Center
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Investigator:
Last name:
W G Hundley, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Investigator:
Last name:
W. G. Hundley, MD
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595577
