Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
Overview
- Phase
- N/A
- Intervention
- Exercise with Trainerize application
- Conditions
- Non Hodgkin Lymphoma
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Change in Peak VO2
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
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)
- •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
Arms & Interventions
Physical Activity Intervention
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.
Intervention: Exercise with Trainerize application
Physical Activity Intervention
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.
Intervention: Cardiopulmonary exercise testing
Physical Activity Intervention
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.
Intervention: MRI scan
Physical Activity Intervention
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.
Intervention: Quality of Life Questionnaires
Physical Activity Intervention
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.
Intervention: Cognitive and Brain Function Questionnaires
Physical Activity Intervention
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.
Intervention: Blood draws
Healthy Living Intervention (Control Arm)
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.
Intervention: MRI scan
Healthy Living Intervention (Control Arm)
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.
Intervention: Cardiopulmonary exercise testing
Healthy Living Intervention (Control Arm)
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.
Intervention: Quality of Life Questionnaires
Healthy Living Intervention (Control Arm)
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.
Intervention: Cognitive and Brain Function Questionnaires
Healthy Living Intervention (Control Arm)
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.
Intervention: Blood draws
Outcomes
Primary Outcomes
Change in Peak VO2
Time Frame: At baseline and 6 months after study intervention
An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.
Secondary Outcomes
- Change in Peak Exercise Cardiac Output(At baseline and 6 months after study intervention)
- Change in Neurocognitive Function - Trail Making Test(At baseline and 6 months after study intervention)
- Change in 6-Minute Walk Distance(At baseline, 3 months and 6 months after study intervention)
- Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B)(At baseline, 3 months and 6 months after study intervention)
- Change in Calculated A-V Oxygen Levels(At baseline and 6 months after study intervention)
- Changes in Measurements of Pre-exercise Left Ventricular Function(At baseline and 6 months after study intervention)
- Change in Neurocognitive Function - Hopkins Verbal Learning Test(At baseline and 6 months after study intervention)
- Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)(At baseline and 6 months after study intervention)
- Fatigue Questionnaire(At baseline, 3 months and 6 months after study intervention)
- Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire(At baseline, 3 months and 6 months after study intervention)
- Change in Physical Function - Balance Test(At baseline, 3 months and 6 months after study intervention)
- Change in Physical Function - 4-Meter Walk Gait Speed Test(At baseline, 3 months and 6 months after study intervention)
- Change in Neurocognitive Function - Digit Span-Backward Test(At baseline and 6 months after study intervention)
- Change in Physical Function - Chair Stand Test(At baseline, 3 months and 6 months after study intervention)
- Change in Physical Function - Grip Strength(At baseline, 3 months and 6 months after study intervention)