Improving Exercise Capacity With a Tailored Physical Activity Intervention — PALS  

Quality of Life Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05595577
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-758-3728
• Email: scnorton@wakehealth.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Completion date: September 1, 2025