Back to resultsExercise to ReGain Stamina and Energy (The EXERGISE Study)
Primary Purpose
Fatigue, Breast Cancer, Cancer, Therapy-Related
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Center-Based Walking Exercise
Home-Based Walking Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
Eligibility Criteria
Inclusion Criteria: Consent to participate in the study Age ≥ 60 years old Had stage I-III invasive breast cancer The cancer is diagnosed in 2021 or 2022 Completed adjuvant therapy for at least 3 months but no more than 1 year Willingness to participate in all study procedures Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure) Exclusion Criteria: Failure to provide informed consent Current involvement in rehabilitation program Absolute contraindications to exercise training Significant cognitive impairment Progressive, degenerative neurologic disease Hip fracture, hip or knee replacement, or spinal surgery within past 4 months Other significant comorbidities that may impair ability to participate in the exercise intervention Pregnant Regular consumption of nicotinamide riboside supplement Simultaneous participation in other interventional studies Had no or very mild fatigue (defined as raw score ≤7 in PROMIS) Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System Receipt of any oral or intravenous antibiotic 4 weeks prior to screening Receipt of any probiotics within 4 weeks of screening History of active treatment for HIV, hepatitis B, or hepatitis C infection Positive stool cultures for enteric pathogens, including Clostridium difficile Excessive alcohol use (i.e., > 14 drinks/week) or alcohol abuse (i.e., > 5 drinks/day for males or > 4 drinks/day for females) Other substance abuse within the past 3 years Smoking history in past 3 years
Sites / Locations
- Institute on Aging; University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Center-Based Walking Exercise
Home-Based Walking Exercise
Arm Description
Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.
Subjects will be randomly assigned to walk for exercise in their community five days/week.
Outcomes
Primary Outcome Measures
Self-Reported Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
Secondary Outcome Measures
Mental Distress (Depression and Anxiety)
Mental distress (depression and anxiety) in past 7 days will be measured by PROMIS. Participants will answer 8 and 7 questions to reflect severity of depression and anxiety, respectively; for each question, a 5-point scale and normalized T-scores will be employed as measure of fatigue.
Self-Reported Pain
Self-reported pain in past 7 days will be measured by 6 questions in PROMIS Pain Interference Short Form; the questions measure severity of pain and use a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much) whose sum can be transformed to a normalized T-score.
Self-Reported Sleep Disturbance
Self-reported sleep short form (8a) that assesses the pure domain of sleep disturbance in individuals aged 18 and older. Each item on the measure is rated on a 5-point scale (1=very good; 2=good; 3=fair; 4=poor; and 5=very poor) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance whose sum can be transformed to a normalized T-score.
Gait Speed
Gait speed will be assessed in by the 6 Minute Walk test, which measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Gait speed will be measured by approach used in the National Health and Nutrition Examination Survey; participants will be asked to finish a 20-foot walking test and gait speed will be calculated as (20×0.3048 meter)/(time (seconds) to finish test).
Physical Function
Physical function will be assessed by the the Short Physical Performance Battery (SPPB). This battery assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test. Additionally, isometric grip strength, a commonly used measure of upper body skeletal function, will be assess with a hand held dynamometer.
Treatment-Induced Peripheral Neuropathy (TIPN)
The 10-item Treatment-induced Neuropathy Assessment Scale (TNAS) will be used to evaluate the severity and impact of peripheral neuropathy on daily functioning at baseline and following or during after chemotherapy treatment. All items are measured based on a 10-point scale. Scores of all items are summed, with higher scores indicating greater neuropathy. Two subscale scores will be calculated to evaluate symptoms related to sensory or interference dimensions. Sensory subscale score will be the mean of 6 sensory items: numbness, tingling, pain, hot or burning, feelings of coldness and disturbed sleep. The interference subscale score - the mean of 3 interference items: trouble walking, trouble with balance and difficulty using hands.
Habitual Physical Activity
Self-administered questionnaire to assess habitual physical activity through three components: work activity, sport activity, and leisure activity. The Modified Baecke Questionnaire measures habitual activity in older adults, which includes questions on household activities, sports and leisure time activities. Free-living physical activity at baseline and follow-up will be measured using an Apple Watch. Adherence to walking exercise intervention will be measured based on four criteria: total walking minutes, total walking minutes within assigned target heart rate zone, percentage of prescribed walking minutes completed per week, and percentage of prescribed walking minutes within the target heart rate zone per week.
Functional Assessment of Cancer Therapy - Breast (FACT-B)
The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer survivors: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). Each item on the measure is rated on a 5 point Likert-type scale (Not at all; A little bit; Somewhat; Quite a bit; and very much).
Perceived Stress
The Perceived Stress Scale (PSS-10) covers feelings and current life situation, both of which are measured on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often); higher scores indicate higher perceived stress.
Dispositional Gratitude
The Gratitude Questionnaire-6 (GQ-6) is designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores range from 6 to 42, with higher scores implying a greater level of dispositional gratitude and lower scores indicating a decreased disposition in gratitude.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684367
Brief Title
Exercise to ReGain Stamina and Energy (The EXERGISE Study)
Official Title
Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
Detailed Description
Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.
In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Breast Cancer, Cancer, Therapy-Related
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Center-Based Walking Exercise
Arm Type
Experimental
Arm Description
Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.
Arm Title
Home-Based Walking Exercise
Arm Type
Experimental
Arm Description
Subjects will be randomly assigned to walk for exercise in their community five days/week.
Intervention Type
Behavioral
Intervention Name(s)
Center-Based Walking Exercise
Intervention Description
Each exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session.
Intervention Type
Behavioral
Intervention Name(s)
Home-Based Walking Exercise
Intervention Description
Participants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session.
Primary Outcome Measure Information:
Title
Self-Reported Fatigue
Description
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
Time Frame
Baseline up to Week 8
Secondary Outcome Measure Information:
Title
Mental Distress (Depression and Anxiety)
Description
Mental distress (depression and anxiety) in past 7 days will be measured by PROMIS. Participants will answer 8 and 7 questions to reflect severity of depression and anxiety, respectively; for each question, a 5-point scale and normalized T-scores will be employed as measure of fatigue.
Time Frame
Baseline up to Week 8
Title
Self-Reported Pain
Description
Self-reported pain in past 7 days will be measured by 6 questions in PROMIS Pain Interference Short Form; the questions measure severity of pain and use a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much) whose sum can be transformed to a normalized T-score.
Time Frame
Baseline up to Week 8
Title
Self-Reported Sleep Disturbance
Description
Self-reported sleep short form (8a) that assesses the pure domain of sleep disturbance in individuals aged 18 and older. Each item on the measure is rated on a 5-point scale (1=very good; 2=good; 3=fair; 4=poor; and 5=very poor) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance whose sum can be transformed to a normalized T-score.
Time Frame
Baseline up to Week 8
Title
Gait Speed
Description
Gait speed will be assessed in by the 6 Minute Walk test, which measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Gait speed will be measured by approach used in the National Health and Nutrition Examination Survey; participants will be asked to finish a 20-foot walking test and gait speed will be calculated as (20×0.3048 meter)/(time (seconds) to finish test).
Time Frame
Baseline up to Week 8
Title
Physical Function
Description
Physical function will be assessed by the the Short Physical Performance Battery (SPPB). This battery assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test. Additionally, isometric grip strength, a commonly used measure of upper body skeletal function, will be assess with a hand held dynamometer.
Time Frame
Baseline up to Week 8
Title
Treatment-Induced Peripheral Neuropathy (TIPN)
Description
The 10-item Treatment-induced Neuropathy Assessment Scale (TNAS) will be used to evaluate the severity and impact of peripheral neuropathy on daily functioning at baseline and following or during after chemotherapy treatment. All items are measured based on a 10-point scale. Scores of all items are summed, with higher scores indicating greater neuropathy. Two subscale scores will be calculated to evaluate symptoms related to sensory or interference dimensions. Sensory subscale score will be the mean of 6 sensory items: numbness, tingling, pain, hot or burning, feelings of coldness and disturbed sleep. The interference subscale score - the mean of 3 interference items: trouble walking, trouble with balance and difficulty using hands.
Time Frame
Baseline up to Week 8
Title
Habitual Physical Activity
Description
Self-administered questionnaire to assess habitual physical activity through three components: work activity, sport activity, and leisure activity. The Modified Baecke Questionnaire measures habitual activity in older adults, which includes questions on household activities, sports and leisure time activities. Free-living physical activity at baseline and follow-up will be measured using an Apple Watch. Adherence to walking exercise intervention will be measured based on four criteria: total walking minutes, total walking minutes within assigned target heart rate zone, percentage of prescribed walking minutes completed per week, and percentage of prescribed walking minutes within the target heart rate zone per week.
Time Frame
Baseline up to Week 8
Title
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Description
The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer survivors: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). Each item on the measure is rated on a 5 point Likert-type scale (Not at all; A little bit; Somewhat; Quite a bit; and very much).
Time Frame
Baseline up to Week 8
Title
Perceived Stress
Description
The Perceived Stress Scale (PSS-10) covers feelings and current life situation, both of which are measured on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often); higher scores indicate higher perceived stress.
Time Frame
Baseline up to Week 8
Title
Dispositional Gratitude
Description
The Gratitude Questionnaire-6 (GQ-6) is designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores range from 6 to 42, with higher scores implying a greater level of dispositional gratitude and lower scores indicating a decreased disposition in gratitude.
Time Frame
Baseline up to Week 8
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Because the study population will be older (60+ years) breast cancer survivors, only women will be enrolled in this pilot study. Although men can also have breast cancer, the risk is extremely low (ratio of male vs. female incident breast cancer = 1:100), thus the study does not consider men in this pilot study.
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consent to participate in the study
Age ≥ 60 years old
Had stage I-III invasive breast cancer
The cancer is diagnosed in 2021 or 2022
Completed adjuvant therapy for at least 3 months but no more than 1 year
Willingness to participate in all study procedures
Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)
Exclusion Criteria:
Failure to provide informed consent
Current involvement in rehabilitation program
Absolute contraindications to exercise training
Significant cognitive impairment
Progressive, degenerative neurologic disease
Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
Other significant comorbidities that may impair ability to participate in the exercise intervention
Pregnant
Regular consumption of nicotinamide riboside supplement
Simultaneous participation in other interventional studies
Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System
Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
Receipt of any probiotics within 4 weeks of screening
History of active treatment for HIV, hepatitis B, or hepatitis C infection
Positive stool cultures for enteric pathogens, including Clostridium difficile
Excessive alcohol use (i.e., > 14 drinks/week) or alcohol abuse (i.e., > 5 drinks/day for males or > 4 drinks/day for females)
Other substance abuse within the past 3 years
Smoking history in past 3 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Anton
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute on Aging; University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise to ReGain Stamina and Energy (The EXERGISE Study)
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