Improving Exercise Capacity With a Tailored Physical Activity Intervention

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05595577
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Cardiopulmonary exercise testing — DIAGNOSTIC_TEST
    Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.
  • MRI scan — DIAGNOSTIC_TEST
    Images of the heart will be taken.
  • 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.
  • 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.
  • 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    Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath.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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Change in Peak VO2 [ Time Frame: At baseline and 6 months after study intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
W G Hundley, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
W. G. Hundley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCVirginia Commonwealth University· Richmond, VA

Related Studies