Study on Physical Activity's Relationship With Cancer and Cognition

NCT03980626 | Completed DMC

• 1 other identifier: 0091-19-FB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). Participants will be randomized to a 12-week walking intervention or usual care. Walking participants will attend small group sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist. All participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue.

Conditions

Breast Cancer; Breast Neoplasm Female

Keywords

physical activity; exercise; cognition; brain health; breast cancer

Outcome Measures

Primary Outcomes (3)

• Change in Executive Function

  A comprehensive neurocognitive battery will be administered to measure executive function as defined by a latent factor of manifest indicators of performance on executive function tasks.

  Baseline, Week 12

• Change in Working Memory

  A comprehensive neurocognitive battery will be administered to measure working memory as defined by a latent factor of manifest indicators of performance on working memory tasks.

  Baseline, Week 12

• Change in Processing Speed

  A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.

  Baseline, Week 12

Secondary Outcomes (7)

• Regional brain volume

  Baseline, Week 12

• White matter structural integrity

  Baseline, Week 12

• Resting state functional connectivity

  Baseline, Week 12

• N2pc Amplitude

  Baseline, Week 12

• Cardiorespiratory Fitness

  Baseline, Week 12

Study Arms (2)

Walking Intervention

EXPERIMENTAL

Walking participants will engage in the 3-times weekly walking program for 12 weeks.

Behavioral: Walking

Usual Care

NO INTERVENTION

Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected.

Interventions

Walking BEHAVIORAL

The exercise intervention is designed to improve cardiorespiratory fitness, a known correlate of cognition and brain health, and follows the American College of Sports Medicine exercise guidelines for cancer survivors. Participants will engage in small group, moderate-to-vigorous intensity walking sessions three times weekly. Sessions will begin with a warm-up and end with a cool down and be progressive in nature. Volume of exercise will increase across weeks such that participants will progress from 15-20 minutes of walking to 40-45 minutes by week 8, and from 40-55% of their estimated heart rate reserve (HRR) to 65% of their HRR by week 9. All sessions will be led by trained exercise specialists to ensure close monitoring of participant safety. Participants will wear heart rate monitors and be asked to rate their perceived exertion to ensure they are exercising within the prescribed range. Modifications to each participant's exercise prescription will be made as needed.

Also known as: Aerobic Exercise Training

Walking Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Post-menopausal at time of diagnosis
• First, primary diagnosis of Stage I-IIIa breast cancer
• Completed treatment 3-24 months prior to study start
• Available to attend exercise sessions 3 times weekly for 12 weeks
• No scheduled travel \>7 consecutive days during the intervention
• Agree to be randomized
• Willingness to wear, charge, and sync Fitbit
• English reading and speaking
• Physician's clearance to exercise
• Provide written informed consent

You may not qualify if:

• Males
• Pre- or peri-menopausal at the time of diagnosis
• Stage 0 or metastatic disease
• Currently receiving chemotherapy or radiation therapy
• More than 24 months post-treatment
• Scheduled to receive breast surgery
• Second cancer diagnosis (excluding non-invasive skin cancers)
• Self-report an average of ≥60 minutes of moderate to vigorous physical activities (MVPA) per week for the previous 6 months
• Not cleared to exercise by a physician
• Not available to attend 3 times weekly exercise sessions for 12 weeks
• Out of town travel scheduled for \>1 week during the intervention
• Unwilling to complete baseline assessments
• Unwilling to be randomized to the exercise or control group
• Unwilling to wear, charge, and sync the Fitbit during the study period
• Unable to read and speak in English

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-8440, United States

Location

Related Publications (1)

• Page LL, Fanning J, Phipps C, Berger A, Reed E, Ehlers D. Heart Rate Monitoring Among Breast Cancer Survivors: Quantitative Study of Device Agreement in a Community-Based Exercise Program. JMIR Cancer. 2024 Jun 20;10:e51210. doi: 10.2196/51210.

  PMID: 38900505 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Diane K Ehlers, PhD

  University of Nebraska

  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: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 10, 2019
• Study Start: September 30, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: When summary data are published.
• Access Criteria: Individual participant data (IPD) will be provided as required by journals in which summary data are published.

Locations

US (1)