Improving Exercise Capacity With a Tailored 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.

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

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.

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.

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Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath.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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• William Hundley, MD · Wake Forest Baptist Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations