Exercise Timing in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Feasibility of Manipulating Exercise Timing in Breast Cancer Survivors on Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821244
• Other study ID #: IRB_00162526
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Adriana M Coletta, PhD, MS, RD
• Phone: 18012136012
• Email: adriana.coletta[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	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	Acceptability	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
Secondary	Whole body physical function	Timed up and go test	Baseline and through study completion, on average four weeks
Secondary	Lower body physical function	30-second chair stand test	Baseline and through study completion, on average four weeks
Secondary	Whole body strength	Handgrip strength test	Baseline and through study completion, on average four weeks
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness test	Baseline and through study completion, on average four weeks