Back to resultsAdaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial (ACTIVATE)
Primary Purpose
Breast Cancer, Invasive Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Intervention
Resistance Exercise Intervention
Exercise Intervention: Digital copies and outline of sessions
Questionnaire Administration
Quality-of-Life Assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, exercise, fatigue, fitness, aerobic, survivor
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Female gender
- Prior diagnosis of invasive breast cancer
- Receipt of chemotherapy or trastuzumab (Herceptin) therapy within the past 6 - 18 months
- Reduced cardiorespiratory functional capacity, defined as < 80% of age/sex-matched six-minute walk distance (6MWD) (i.e. a 20% shorter distance)
Exclusion Criteria:
- Currently exercising >150 min/week
- Actively receiving chemotherapy or radiation
- Medical history of heart failure, coronary artery disease or arrhythmia
- Contraindications to cardiopulmonary exercise testing (CPET)
- 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
- Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
- Unwilling to complete intervention procedures or outcome measures
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm I (aerobic exercise)
Arm II (resistance exercise)
Control Group (digital exercise interventions)
Arm Description
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Study feasibility
Study feasibility will be measured by calculating recruitment rates (proportion of enrolled participants to all individuals approached), lost to follow-up (proportion of participants who do not complete post-intervention assessments), relative dose intensity (proportion of completed to planned sessions), early session terminations (proportion of sessions ended by participant prior to completing planned duration), intervention interruptions (missing 3 or more planned sessions consecutively), attendance (proportion of attended to planned sessions), and adherence (gathered from heart rate /accelerometry data and self-report of exercise via questionnaires). A benchmark to determine feasibility is < 40% loss to follow-up.
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.
Intervention session intensity
The Rating of Perceived Exertion (RPE) scale asks respondents to rate the intensity of exercise on a 6 - 20 scale. The measure has been validated for estimating both aerobic and resistance exercise exertion levels, providing a standard measure across intervention modalities.
Intervention adherence
Participants will wear 2 devices during the study: a waist-worn actigraph and a wrist-worn FitBit activity monitor. The actigraph will be worn for 7 day intervals immediately prior to the baseline and endpoint assessments. In addition, participants will be asked to wear the actigraph 24-hours per day during that 7-day interval with the exception of when engaged in water activities for the duration of their intervention participation. Together, these data will be used to gauge adherence to the exercise intervention. The raw data generated from these devices will be reviewed by a trained accelerometer analyst for quality control and cleaning. Then the analyst will calculate the amount of time (in min/per day) spent in activities of low-, moderate-, and vigorous-activity. Categorization of the level of physical activity will use accepted cut points from the literature.
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).
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).
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.
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.
Anthropometrics (Height)
Height will be measured while the participant stands without shoes using a wall-mounted stadiometer to the nearest one-tenth cm.
Anthropometrics (Hip circumference)
Hip circumference will be measured to the nearest one-tenth cm.
Anthropometrics (Waist circumference)
Waist circumference will be measured to the nearest one-tenth cm.
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.
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.
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.
Physical activity and sedentary behaviors (IPAQ)
Time spent engaging in physical activity and in sedentary lifestyle behaviors will be measured with the self-administered International Physical Activity Questionnaire (IPAQ). The IPAQ assesses minutes spent performing moderate or vigorous exercise during activities of daily living over the past week, including exercise.
Physical activity and sedentary behaviors (SBQ)
Time spent engaging in physical activity and 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.
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.
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.
Full Information
NCT ID
NCT04667481
First Posted
November 9, 2020
Last Updated
November 30, 2022
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04667481
Brief Title
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
Acronym
ACTIVATE
Official Title
Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Invasive Breast Carcinoma
Keywords
breast cancer, exercise, fatigue, fitness, aerobic, survivor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (aerobic exercise)
Arm Type
Experimental
Arm Description
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
Arm Title
Arm II (resistance exercise)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (digital exercise interventions)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Intervention
Intervention Description
Participate in aerobic exercise intervention
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Intervention
Intervention Description
Participate in resistance exercise intervention
Intervention Type
Other
Intervention Name(s)
Exercise Intervention: Digital copies and outline of sessions
Intervention Description
Receive digital copy of AE and RE sessions and an outline of sessions
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Intervention feasibility
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Intervention safety: adverse events
Description
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.
Time Frame
Up to 24 weeks
Title
Study feasibility
Description
Study feasibility will be measured by calculating recruitment rates (proportion of enrolled participants to all individuals approached), lost to follow-up (proportion of participants who do not complete post-intervention assessments), relative dose intensity (proportion of completed to planned sessions), early session terminations (proportion of sessions ended by participant prior to completing planned duration), intervention interruptions (missing 3 or more planned sessions consecutively), attendance (proportion of attended to planned sessions), and adherence (gathered from heart rate /accelerometry data and self-report of exercise via questionnaires). A benchmark to determine feasibility is < 40% loss to follow-up.
Time Frame
Up to 24 weeks
Title
Intervention acceptability
Description
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.
Time Frame
Up to 24 weeks
Title
Intervention session intensity
Description
The Rating of Perceived Exertion (RPE) scale asks respondents to rate the intensity of exercise on a 6 - 20 scale. The measure has been validated for estimating both aerobic and resistance exercise exertion levels, providing a standard measure across intervention modalities.
Time Frame
Up to 24 weeks
Title
Intervention adherence
Description
Participants will wear 2 devices during the study: a waist-worn actigraph and a wrist-worn FitBit activity monitor. The actigraph will be worn for 7 day intervals immediately prior to the baseline and endpoint assessments. In addition, participants will be asked to wear the actigraph 24-hours per day during that 7-day interval with the exception of when engaged in water activities for the duration of their intervention participation. Together, these data will be used to gauge adherence to the exercise intervention. The raw data generated from these devices will be reviewed by a trained accelerometer analyst for quality control and cleaning. Then the analyst will calculate the amount of time (in min/per day) spent in activities of low-, moderate-, and vigorous-activity. Categorization of the level of physical activity will use accepted cut points from the literature.
Time Frame
Up to 24 weeks
Title
Maximal exercise capacity (absolute)
Description
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).
Time Frame
Up to 24 weeks
Title
Maximal exercise capacity (relative to bodyweight)
Description
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).
Time Frame
Up to 24 weeks
Title
Submaximal exercise capacity
Description
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.
Time Frame
Up to 24 weeks
Title
Anthropometrics (Weight)
Description
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.
Time Frame
Up to 24 weeks
Title
Anthropometrics (Height)
Description
Height will be measured while the participant stands without shoes using a wall-mounted stadiometer to the nearest one-tenth cm.
Time Frame
Up to 24 weeks
Title
Anthropometrics (Hip circumference)
Description
Hip circumference will be measured to the nearest one-tenth cm.
Time Frame
Up to 24 weeks
Title
Anthropometrics (Waist circumference)
Description
Waist circumference will be measured to the nearest one-tenth cm.
Time Frame
Up to 24 weeks
Title
Intermuscular fat (IMF)
Description
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.
Time Frame
Up to 24 weeks
Title
Abdominal deposits of fat
Description
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.
Time Frame
Up to 24 weeks
Title
Change in quality of life
Description
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.
Time Frame
Up to 24 weeks
Title
Physical activity and sedentary behaviors (IPAQ)
Description
Time spent engaging in physical activity and in sedentary lifestyle behaviors will be measured with the self-administered International Physical Activity Questionnaire (IPAQ). The IPAQ assesses minutes spent performing moderate or vigorous exercise during activities of daily living over the past week, including exercise.
Time Frame
Up to 24 weeks
Title
Physical activity and sedentary behaviors (SBQ)
Description
Time spent engaging in physical activity and 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.
Time Frame
Up to 24 weeks
Title
Perceived well-being
Description
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.
Time Frame
Up to 24 weeks
Title
Level of fatigue
Description
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.
Time Frame
Up to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Female gender
Prior diagnosis of invasive breast cancer
Receipt of chemotherapy or trastuzumab (Herceptin) therapy within the past 6 - 18 months
Reduced cardiorespiratory functional capacity, defined as < 80% of age/sex-matched six-minute walk distance (6MWD) (i.e. a 20% shorter distance)
Exclusion Criteria:
Currently exercising >150 min/week
Actively receiving chemotherapy or radiation
Medical history of heart failure, coronary artery disease or arrhythmia
Contraindications to cardiopulmonary exercise testing (CPET)
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
Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
Unwilling to complete intervention procedures or outcome measures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerryn W Reding, PhD, MPH, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
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