Improving Exercise Capacity With a Tailored Physical Activity Intervention

NCT05595577 | Recruiting DMC FDA Device

• 3 other identifiers: IRB000877634R33CA226960-03WFBCCC 98622
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Exercise capability; Brain activity

Outcome Measures

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.

  At baseline and 6 months after study intervention

Secondary Outcomes (15)

• Change in Peak Exercise Cardiac Output

  At baseline 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

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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.

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

Healthy Living Intervention (Control Arm)

EXPERIMENTAL

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.

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

Interventions

Cardiopulmonary exercise testing DIAGNOSTIC_TEST

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

Healthy Living Intervention (Control Arm); Physical Activity Intervention

MRI scan DIAGNOSTIC_TEST

Images of the heart will be taken.

Healthy Living Intervention (Control Arm); Physical Activity Intervention

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.

Healthy Living Intervention (Control Arm); Physical Activity Intervention

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.

Healthy Living Intervention (Control Arm); Physical Activity Intervention

Blood draws OTHER

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.

Healthy Living Intervention (Control Arm); Physical Activity Intervention

Exercise with Trainerize application OTHER

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.

Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Breast Neoplasms

Interventions

Exercise; Exercise Test; Magnetic Resonance Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Tomography; Diagnostic Imaging; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• William Hundley, MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

336-758-3027; johnkc22@wfu.edu

Pamela J. Grizzard

CONTACT

804-628-6234; pamela.grizzard@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All images will be processed offline by an image analyst blinded to study group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)