NCT03923504

Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.

Detailed description

This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).

Conditions

• Hodgkin Lymphoma
• Non-hodgkin Lymphoma
• Lymphoma
• Breast Cancer

Interventions

Type	Name	Description
OTHER	Physical Activity Intervention (PAI)	Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 \& 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home.
OTHER	Healthy Living Control	Patients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible.

Timeline

• Start date: 2019-05-10
• Primary completion: 2022-04-18
• Completion: 2022-04-18
• First posted: 2019-04-22
• Last updated: 2023-03-07

Locations

2 sites across 1 country: United States