Exercise Timing in Breast Cancer Patients

July 7, 2023 updated by: Adriana Coletta, University of Utah

Feasibility of Manipulating Exercise Timing in Breast Cancer Survivors on Chemotherapy

The purpose of this study is to demonstrate the feasibility of assigning breast cancer survivors currently receiving chemotherapy to exercise at a specific time of day, e.g., morning or afternoon/evening, for a 4-week exercise intervention. Information gathered from this study will help inform a future, larger trial.

Study Aims:

1. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Assigning windows of time within the day to complete exercise (e.g. 5-10am exercise start time vs. 3-8pm exercise start time) will be feasible among this patient population.

1a. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Engaging in exercise at an assigned time-of-day will be acceptable in this patient population.

2. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables. Tests to be conducted at baseline and end of study to measure physical function and human performance variables include: Timed up and go test, 30-second chair stand, handgrip strength, cardiorespiratory fitness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized 1:1 to an exercise timing group (AM or PM), of which they will be required to complete their exercise during a specific time of day. Participants randomized to the AM group will be required to start their exercise between 5am and 10am for the duration of the 4-week intervention. Participants randomized to the PM group will be required to start their exercise between 3pm and 8pm.

At baseline and end of study assessments, participants will complete the following physical tests to evaluate physical function, strength, and cardiorespiratory fitness: timed up and go test, 30-second chair stand test, handgrip strength test, cardiorespiratory fitness test. These tests and assessments will be carried out with the Huntsman Cancer Institute (HCI) Wellness Center's Personal Optimism With Exercise Recovery (POWER) program. These tests will occur at the HCI Wellness Center gym. At the end of study assessments participants will also be asked to complete an exit survey, and two short questionnaires related to sleeping and eating habits.

Participants will complete two personalized resistance exercise training sessions supervised by a Cancer Exercise Specialist via the telehealth platform in the electronic medical record. These resistance training sessions are part of the POWER program. Participants will also be required to engage in weekly, moderate-intensity aerobic exercise, with the goal of completing 90 minutes of aerobic exercise per week. The type of aerobic exercise engaged in (e.g., walking, biking, hiking, etc), and location to complete the aerobic exercise (e.g., at home, local park, local gym, HCI Wellness Center gym, etc.) is the participant's choice. Participant's will be required to submit weekly aerobic exercise training logs.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at the University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage I-III Breast Cancer patients with plans to start chemotherapy or just started chemotherapy. Just started chemotherapy is defined as already receiving one cycle of chemotherapy.
  • ECOG 0, 1, 2

Exclusion Criteria:

  • Stage IV Breast cancer patients
  • ECOG >/= 3
  • Stage I-III Breast Cancer patients who do not have plans to start chemotherapy or who have received more than one cycle of breast cancer chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morning Group
Participants must start their exercise between the hours of 5am and 10am.
Behavioral: Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.
Experimental: Evening Group
Participants must start their exercise between the hours of 3pm and 8pm.
Behavioral: Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention
Time Frame: through study completion, on average four weeks
The proportion of patients who complete at least 75% of their assigned workouts within the time-of-day window assigned throughout the four-week assessment period
through study completion, on average four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: through study completion, on average four weeks
Study acceptability will be measured as the proportion of patients who qualitatively report a positive response to at least half of exit survey themes.
through study completion, on average four weeks
Whole body physical function
Time Frame: Baseline and through study completion, on average four weeks
Timed up and go test
Baseline and through study completion, on average four weeks
Lower body physical function
Time Frame: Baseline and through study completion, on average four weeks
30-second chair stand test
Baseline and through study completion, on average four weeks
Whole body strength
Time Frame: Baseline and through study completion, on average four weeks
Handgrip strength test
Baseline and through study completion, on average four weeks
Cardiorespiratory fitness
Time Frame: Baseline and through study completion, on average four weeks
Cardiorespiratory fitness test
Baseline and through study completion, on average four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Adriana M Coletta, PhD, MS, RD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00162526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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