NCT05595577

Improving Exercise Capacity With a Tailored Physical Activity Intervention

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Exercise with Trainerize application	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.
DIAGNOSTIC_TEST	Cardiopulmonary exercise testing	Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.
DIAGNOSTIC_TEST	MRI scan	Images of the heart will be taken.
BEHAVIORAL	Quality of Life Questionnaires	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.
BEHAVIORAL	Cognitive and Brain Function Questionnaires	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.
OTHER	Blood draws	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2022-10-27
• Last updated: 2026-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study