Exercise Timing in Breast Cancer Patients

NCT05821244 | Completed

• 1 other identifier: IRB_00162526
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Exercise; Resistance Training; Aerobic Exercise; Exercise Time-of-Day; Breast Cancer; Breast Cancer Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Acceptability

  through study completion, on average four weeks

• Whole body physical function

  Baseline and through study completion, on average four weeks

• Lower body physical function

  Baseline and through study completion, on average four weeks

• Whole body strength

  Baseline and through study completion, on average four weeks

• Cardiorespiratory fitness

  Baseline and through study completion, on average four weeks

Study Arms (2)

Morning Group

EXPERIMENTAL

Participants must start their exercise between the hours of 5am and 10am.

Behavioral: Exercise Timing Groups

Evening Group

EXPERIMENTAL

Participants must start their exercise between the hours of 3pm and 8pm.

Behavioral: Exercise Timing Groups

Interventions

Exercise Timing Groups BEHAVIORAL

Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.

Evening Group; Morning Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Adriana M Coletta, PhD, MS, RD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 20, 2023
• Study Start: July 5, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)