High-intensity Exercise After Treatment

NCT04950010 | Terminated DMC

• 2 other identifiers: 0439-21-FB1U54GM115458
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).

Conditions

Breast Cancer; Breast Neoplasm Female

Keywords

breast cancer; physical activity; cognitive function; exercise; cardiovascular function

Outcome Measures

Primary Outcomes (7)

• Participation Rate

  Sample size / \[1-(#ineligible/# exposed to recruitment)\*(#exposed to recruitment)\]

  Baseline

• Adherence to the exercise programs

  average number of exercise sessions (out of 24) attended

  post-intervention (Week 9)

• Compliance of the exercise programs

  average number of exercise sessions (out of 24) in which the prescribed exercise duration and intensity are achieved

  post-intervention

• Acceptability of the exercise programs

  satisfaction with the exercise program as measured by a satisfaction survey. Survey uses a 5-point Likert-type scale. Satisfaction for each item is defined as reporting 4-5 on the scale (i.e., somewhat agree or completely agree).

  post-intervention

• Change in executive function processing

  Change in completion time on Trails B task, with higher values indicating lower executive function.

  Baseline, post-intervention (Week 9)

• Change in cognitive flexibility

  Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility

  Baseline, post-intervention (Week 9)

• Change in spatial working memory reaction time

  Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory

  Baseline, post-intervention (Week 9)

Secondary Outcomes (3)

• Change in Cardiorespiratory Fitness

  Baseline, post-intervention (Week 9)

• Carotid arterial wall thickness

  Baseline, post-intervention (Week 9)

• Endothelial function

  Baseline, post-intervention (Week 9)

Study Arms (3)

High-Intensity Interval Training (HIIT)

EXPERIMENTAL

Breast cancer survivors randomized to HIIT will participate in a high-intensity interval training program for 8 weeks.

Behavioral: High-Intensity Interval Training

Moderate-Intensity Exercise (MOD)

ACTIVE COMPARATOR

Breast cancer survivors randomized to MOD will participate in a moderate-intensity aerobic exercise program for 8 weeks.

Behavioral: Moderate-Intensity Exercise

Usual Care (UC)

NO INTERVENTION

Individuals randomized to UC will be instructed to continue standard cancer care and engage in habitual lifestyle behaviors.

Interventions

High-Intensity Interval Training BEHAVIORAL

HIIT is a type of training in which short periods of high-intensity anaerobic exercise (1-4 minutes at 80-95% of VO2peak) are alternated with less intense aerobic recovery periods (1-3 minutes at 50-60% VO2peak). Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise (i.e., number and intensity of intervals) increases across weeks. Intervals will progress from a heart rate corresponding with 75% VO2peak in Week 1 to 90-95% VO2peak in Weeks 5-8. Sessions will be \~30 minutes in length. Indoor cycling is the primary mode of exercise.

High-Intensity Interval Training (HIIT)

Moderate-Intensity Exercise BEHAVIORAL

Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Indoor cycling is the primary mode of exercise. Sessions will include moderate-intensity cycling that progresses from a heart rate corresponding with 55-60% VO2peak for 30 minutes in Week 1 to 65-70% VO2peak for 45-50 minutes in Weeks 5-8.

Moderate-Intensity Exercise (MOD)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female (aged 19 or older)
• First, primary diagnosis of Stage I-IIIa breast cancer
• Hormone receptor positive (ER+ and/or PR+) diagnosis
• Human epidermal growth factor receptor 2 negative (HER2-) diagnosis
• Completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
• Currently prescribed an aromatase inhibitor
• No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive Status (TICS-M; score \>21)
• Sedentary except for casual lifestyle recreation. This is defined as self-reporting 20+ minutes of exercise physical activity on 2 or fewer days per week within the previous six months.
• Receive physician's clearance to participate in an exercise program
• Agree to be randomized
• Fully vaccinated for COVID-19 ≥2 weeks prior to participation
• Provide written informed consent to participate in study

You may not qualify if:

• Males.
• Stage 0 breast cancer diagnosis or metastatic disease
• Currently receiving chemotherapy or radiation therapy for any cancer
• Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period
• Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
• Self-report an 20+ minutes of exercise physical activity on 3+ days per week for the previous 6 months
• Pregnant or plan to become pregnant during study period.
• Is not cleared to participate in exercise by a physician.
• Enrolled in another physical activity program
• Unable to cycle on a stationary bike
• Unwilling to complete study requirements
• History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
• Clinically significant TICS-M score (\<21) during baseline procedures
• Not fully vaccinated for COVID-19

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diane Ehlers, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 2, 2021
• Study Start: March 28, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared via scientific journals at the time of publication and with outside collaborators before publication.
• Access Criteria: We will make data available to researchers who agree to use the data only for research purposes, protect the data using secure computer technologies, and destroy the data after relevant analyses are completed and manuscripts published.

Locations

US (1)