High-intensity Exercise After Treatment

Breast Cancer Clinical Trial

— HEAT  

Official title:

Enhancing Cognitive and Cardiovascular Function in Breast Cancer Survivors Through High-intensity Interval Training

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04950010
• Other study ID #: 0439-21-FB
• Secondary ID: 1U54GM115458
• Status: Terminated
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Aim 1: Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity aerobic training (MOD) program in 45 breast cancer survivors prescribed aromatase inhibitors.

Aim 2: Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and Usual Care (UC), on cognitive and cardiovascular functions in 45 breast cancer survivors.

Eligible individuals will be women diagnosed with Stages I-IIIa breast cancer, have completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy), and currently prescribed an aromatase inhibitor. The specific aims are: 1) Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity (MOD) program; and 2) Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and usual care (UC), on cognitive and cardiovascular functions. Cognitive function is operationalized as performance on executive function and working memory tasks. Cardiovascular function is operationalized as exercise capacity (VO2peak, heart rate recovery), resting function (heart rate, blood pressure), and cardiovascular structure/function (arterial stiffness, arterial wall thickness, endothelial function). Associations between change in cardiovascular outcomes and change in cognitive outcomes across the intervention period will also be explored.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Behavioral:
• High-Intensity Interval Training
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.
• Moderate-Intensity Exercise
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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation Rate	Sample size / [1-(#ineligible/# exposed to recruitment)*(#exposed to recruitment)]	Baseline
Primary	Adherence to the exercise programs	average number of exercise sessions (out of 24) attended	post-intervention (Week 9)
Primary	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
Primary	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
Primary	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)
Primary	Change in cognitive flexibility	Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility	Baseline, post-intervention (Week 9)
Primary	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	Change in Cardiorespiratory Fitness	Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.	Baseline, post-intervention (Week 9)
Secondary	Carotid arterial wall thickness	will be estimated from vascular ultrasound and expressed as average and maximum mm	Baseline, post-intervention (Week 9)
Secondary	Endothelial function	estimated from brachial artery flow mediated dilation and expressed as percent change in brachial artery diameter relative to baseline diameter	Baseline, post-intervention (Week 9)