Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

Breast Cancer Clinical Trial

— ACTIVATE  

Official title:

Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667481
• Other study ID #: RG1121129
• Secondary ID: P30CA01570410872
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: November 10, 2022

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

Description:

OUTLINE: Patients are randomized to the interventional groups or control group. INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms. ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks. ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks. CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 75 years, inclusive

2. Female gender

3. Prior diagnosis of invasive breast cancer

4. Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)

5. Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls

Exclusion Criteria:

1. Actively receiving radiation treatment

2. Medical history of heart failure, coronary artery disease or arrhythmia

3. Contraindications to cardiopulmonary exercise testing (CPET)

4. Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia

5. Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably

6. Unwilling to complete intervention procedures or outcome measures

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Invasive Breast Carcinoma

Intervention

Other:
• Aerobic Exercise Intervention
Participate in aerobic exercise intervention
• Resistance Exercise Intervention
Participate in resistance exercise intervention
• Exercise Intervention: Digital copies and outline of sessions
Receive digital copy of AE and RE sessions and an outline of sessions
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximal Exercise Capacity (Absolute)	This is operationalized as maximal exercise capacity, which is ascertained by measuring peak oxygen consumption (volume oxygen [VO2] peak) during cardiopulmonary exercise testing (CPET). All CPETs will be administered by a trained exercise physiologist using the Modified Bruce protocol, an appropriate testing paradigm for people with reduced physical functioning. This procedure will estimate the VO2 (absolute).	Up to 24 weeks
Other	Maximal Exercise Capacity (Relative to Bodyweight)	This is operationalized as maximal exercise capacity, which is ascertained by measuring peak oxygen consumption (volume oxygen [VO2] peak) during cardiopulmonary exercise testing (CPET). All CPETs will be administered by a trained exercise physiologist using the Modified Bruce protocol, an appropriate testing paradigm for people with reduced physical functioning. This procedure will estimate the VO2 (relative to bodyweight).	Up to 24 weeks
Other	Submaximal Exercise Capacity	Submaximal exercise capacity, also considered functional capacity, will be determined with the six minute walk test (6MWT), which measures the distance a person can walk in six minutes (6MWD). A widely used measure of submaximal exercise capacity, the 6MWT will be administered at all study timepoints to evaluate intervention response.	Up to 24 weeks
Other	Anthropometrics (Weight)	Prior to the measurement of body weight, participants will be instructed to remove heavy clothing and empty pockets of their contents. Weight will be measured to the nearest one-tenth kg with a calibrated balance beam or digital scale.	Up to 24 weeks
Other	Anthropometrics (Hip Circumference)	Hip circumference will be measured to the nearest one-tenth cm.	Up to 24 weeks
Other	Anthropometrics (Height)	Height will be measured while the participant stands without shoes using a wall-mounted stadiometer to the nearest one-tenth cm.	Up to 24 weeks
Other	Abdominal Deposits of Fat	Subcutaneous (SQ) fat and visceral adipose tissue (VAT) will be assessed via abdominal MRI. For analysis, fat depots will be separated into abdominal SQ fat and VAT which will be further segmented into intraperitoneal (IP) and retroperitoneal (RP) fat using commercially available software. SQ fat will be defined as the fat outside the muscular abdominal wall; IP fat as fat within the mesentery and omentum bounded anteriorly and laterally by the abdominal wall and posteriorly by a curved line drawn between the kidneys; RP fat as the remaining fat. Adipose tissues will be segmented and colored from other tissues based on pixel intensity and known divisions of tissue planes. The MRI analyst, blinded to participant characteristics, will correct any misidentified fat or non-fat regions using manual tools provided within the software. To calculate each of the compartmental fat deposits, the number of subpixels within each fat compartment.	Up to 24 weeks
Other	Intermuscular Fat (IMF)	The ratio of thigh IMF to skeletal muscle (SM) will be ascertained via magnetic resonance imaging (MRI) by trained MRI technologists. Participants will undergo a screening process with the MRI technologist to ensure that eligibility criteria for MRI scans are met. Participants will then change into a hospital gown and enter the MRI scanner. In this longitudinal assessment of IMF, the MRI technologist will be instructed to match participant scan positions across time by matching the current scan position with the participant's previous scan position, recorded at the timepoint prior. MRI analysts will quantitate total and compartment amounts of muscle and adipose tissue using cross-sectional areas of thigh skeletal muscle (SM) and IMF using commercially available software. Thigh IMF area will be calculated as the number of fat pixels within the thigh musculature multiplied by the pixel surface area.	Up to 24 weeks
Other	Anthropometrics (Waist Circumference)	Waist circumference will be measured to the nearest one-tenth cm.	Up to 24 weeks
Other	Change in Quality of Life	The Short Form Health Survey-36 (SF-36) is a widely used self-report measure of quality of life and health status. Comprised of 36 multiple choice questions, the SF-36 queries general perceptions a participant has about their health, as well as limitations to physical activity, physical health problems, mental health problems, pain, and energy/fatigue. The SF-36 is used across health research domains, and in breast cancer has been validated as a reliable longitudinal monitor of quality of life.	Up to 24 weeks
Other	Physical Activity and Sedentary Behaviors (IPAQ)	Time spent engaging in physical activity will be measured with the Physical Activity Recall Interview. The PAR assesses time spent in physical activity over the past 7 days.	Up to 24 weeks
Other	Perceived Well-being	Participants' perception of their current well-being will be assessed with the 28-item 5-point Likert scale Functional Assessment of Cancer Therapy (FACT)-General. The FACT-G contains 4 subscales measuring physical, social, emotional, and functional well-being and has been validated for reliably measuring well-being in cancer patients.	Up to 24 weeks
Other	Physical Activity and Sedentary Behaviors (SBQ)	Time spent engaging in sedentary lifestyle behaviors will be measured with the self-administered Sedentary Behaviors Questionnaire (SBQ). The SBQ measures the minutes spent participating in 9 different sedentary behaviors per "typical" weekday and weekend day.	Up to 24 weeks
Other	Level of Fatigue	The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale is a 13-item scale originally developed for and widely used to assess cancer-related fatigue. The FACIT-Fatigue scale measures severity (i.e., "I feel fatigued"; "I feel weak all over") and impact of fatigue (e.g., "I need help doing my usual activities"; "I have to limit my social activity because I am tired") over the past week, with responses scored on a 5-point scale, from 0 "not at all" to 4 "very much." The FACIT-Fatigue scale has excellent psychometric properties and a focus on physical aspects of fatigue.	Up to 24 weeks
Primary	Intervention Feasibility	Will be determined with all-cause intervention discontinuation rate, which is the proportion of all intervention participants who permanently stop the intervention prior to week 24 for any reason.	Week 24
Secondary	Intervention Safety: Adverse Events	Intervention safety will be determined by reviewing and quantifying the number of adverse events (mild, moderate, or severe), serious adverse events, and by reviewing the type and severity of adverse events attributed to study procedures among each study group.	Up to 24 weeks
Secondary	Study Feasibility	Study feasibility will be measured by calculating recruitment rates (proportion of enrolled participants to all individuals approached), and loss to follow-up (proportion of participants who do not complete post-intervention assessments). A benchmark to determine feasibility is < 40% loss to follow-up.	Up to 24 weeks
Secondary	Intervention Acceptability	Acceptability will be measured with qualitative, open-ended to assess participant experience in the intervention and gather information for improving the protocol in future studies. Of particular attention will be the tolerability of a remote, home-based exercise intervention with a semi supervised format.	Up to 24 weeks
Secondary	Intervention Session Intensity	The Rating of Perceived Exertion (RPE) scale asks respondents to rate the intensity of exercise on a 1-10 scale, with higher values representing greater perceived exertion (1 = Very Light Activity, 10 = Maximum Possible Exertion). The measure has been validated for estimating both aerobic and resistance exercise exertion levels, providing a standard measure across intervention modalities. The average RPE for full-intensity sessions (the first few weeks involve an increasing RPE across sessions) will be calculated for each participant.	Up to 24 weeks
Secondary	Intervention Adherence	Participants will complete an RPE rating after each session. These ratings will be used to calculate adherence rate for each participant. A session with an RPE that is at or above the intended RPE will be considered adherent. The number of adherent sessions will be divided by the total number of sessions, whether the session was attended or not. The participant adherence rates will be averaged to find a mean adherence rate per participant.	Up to 24 weeks