Back to resultsResistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
Primary Purpose
Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance training (RT)
Cognitively-based compassion training control (CBCT)
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring Breast Cancer Survivors, Resistance Training, Fatigue, Physical Function, Behavioral Function, Kynurenine metabolism
Eligibility Criteria
Inclusion Criteria:
- within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
- at least 6 months post breast reconstruction (if applicable),
- lack of menses for at least one year,
- BMI 20-35 kg/m2,
- fatigued (subjective reporting ≥3 on a 1-10 scale),
- untrained with regard to structured resistance training (no more than 3x/week).
Exclusion Criteria:
- plans for surgery (e.g., breast reconstruction) during the study period,
- taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
- allergic to lidocaine,
- orthopedic or chronic pain condition restricting exercise,
- Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education),
- unable to receive physician medical clearance.
Sites / Locations
- Winship Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resistance training
Cognitively-based compassion training
Arm Description
Outcomes
Primary Outcome Measures
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each scale contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.
Secondary Outcome Measures
Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Change in balance test score
Berg Balance Scale is an observer rated scale developed to rate fall risk that consists of 14 items (0-4 point scale) of mobility related to balance.
Change in muscle function assessed by Isometric Handgrip test.
Hand grip strength of both arms will be assessed using a handheld dynamometer. The subjects will be tested while seated with the shoulders adducted, the elbow flexed to 90 degrees, and the forearm in a neutral position. The subjects will be instructed to "squeeze as hard as possible" during 3-5 second efforts.
Change in muscle function assessed by Lower Extremity Endurance test
The subjects will be asked to perform the leg press and leg extension exercises at 60% of maximum strength as many times as they can before fatigue, paced by a metronome set to 30. Endurance in the right and left legs will be tested separately using equipment that is built to isolate single leg movement.
Change in muscle function assessed by Lower Extremity Strength test
Standardized strength assessment protocol that includes 4-6 trials with rest periods of the leg extension, leg press, and chest press exercises will be used. Strength in the right and left legs will be tested separately.
Change in Timed Up and Go (TUG) completion time
Subjects are observed and timed while they rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time to complete this task will be recorded.
Change in 30 meter walk velocity
Self-selected and fastest-comfortable floor walking velocity will be determined from 30 meter walks with subjects using the same assistive device and/or orthosis as normally used to "walk across the room at home."
Change in Functional Gait Assessment score
Subjects will be asked to perform various tasks to assess functional gait including stepping onto a small stool, doing a turn, and picking a small object off the floor. Participants will be scored on their ability to perform each task without difficulty. A total score out of a maximum of 30 points will be reported.
Change in 6 min walk distance
Subjects will use the same assistive device typically used and will be instructed to cover as much distance as they can in six minutes over a flat walking surface.
Change in Resting Metabolic Rate (RMR)
RMR will be measured using the ventilated hood technique while subjects lie quietly in bed for 30-45 mins under a clear plastic hood with expired air collected through a one-way valve. RMR will be measured at rest under fasting conditions. It will be reported as a continuous variable of kilocalories/day.
Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) is a key transcription coactivator regulating energy metabolism in a tissue-specific manner. PGC-1α level will be measured by enzyme-linked immunosorbent assay in blood sample.
Change in kynurenic acid level
Kynurenic acid is a product of the normal metabolism of amino acid L-tryptophan. It has been shown that kynurenic acid possesses neuroactive activity. Kynurenic acid level will be measured by enzyme-linked immunosorbent assay in blood sample. .
Change in interleukin-6 (IL-6) level
IL-6 is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory marker in skeletal muscle. IL-6 level will be measured by enzyme-linked immunosorbent assay in blood sample.
Change in tumor necrosis factor-α (TNF-α) protein level
tumor necrosis factor-α (TNF-α) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction.TNF-α protein level will be measured by enzyme-linked immunosorbent assay in blood sample.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03539835
Brief Title
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
Official Title
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following Resistance Training (RT) and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.
Detailed Description
Interventions that reduce pro-inflammatory cytokines with resultant stimulation of kynurenine metabolism may be increasingly important in Breast Cancer Survivors (BCS) to prevent susceptibility to cancer associated fatigue, depression, and declines in muscle mass and function.
There is emerging evidence that supports exercise as a non-pharmacological therapy to prevent cancer recurrence, sedentary behaviors, and obesity during cancer survivorship . It seems that interventions that include resistance training (RT) are most efficacious at reducing fatigue in BCS This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following RT and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Breast Cancer Survivors, Resistance Training, Fatigue, Physical Function, Behavioral Function, Kynurenine metabolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance training
Arm Type
Experimental
Arm Title
Cognitively-based compassion training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Resistance training (RT)
Intervention Description
Resistance training (RT) will include 15 repetitions for two sets and to exhaustion on the third set for seven major muscle groups: the leg and chest press, knee extension, leg curl, row, abdominal crunch, and bicep curl. Resistance is gradually increased to account for strength gains when subjects are able to complete 20 repetitions on the third set.
Intervention Type
Behavioral
Intervention Name(s)
Cognitively-based compassion training control (CBCT)
Intervention Description
Cognitively-based compassion training control (CBCT) classes will be performed in a group setting for 1.5-2 hours per week, and consist of didactics, class discussion, and guided meditation practice. Each class will begin with a period of meditation to calm and focus the mind, followed by analytical practices designed to challenge unexamined assumptions regarding feelings, and actions toward others with a focus on generating spontaneous empathy and compassion for themselves and others.
Primary Outcome Measure Information:
Title
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
Description
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each scale contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.
Time Frame
Baseline, 12 weeks follow up
Secondary Outcome Measure Information:
Title
Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
Description
Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Time Frame
Baseline, 12 weeks follow up
Title
Change in balance test score
Description
Berg Balance Scale is an observer rated scale developed to rate fall risk that consists of 14 items (0-4 point scale) of mobility related to balance.
Time Frame
Baseline, 12 weeks follow up
Title
Change in muscle function assessed by Isometric Handgrip test.
Description
Hand grip strength of both arms will be assessed using a handheld dynamometer. The subjects will be tested while seated with the shoulders adducted, the elbow flexed to 90 degrees, and the forearm in a neutral position. The subjects will be instructed to "squeeze as hard as possible" during 3-5 second efforts.
Time Frame
Baseline, 12 weeks follow up
Title
Change in muscle function assessed by Lower Extremity Endurance test
Description
The subjects will be asked to perform the leg press and leg extension exercises at 60% of maximum strength as many times as they can before fatigue, paced by a metronome set to 30. Endurance in the right and left legs will be tested separately using equipment that is built to isolate single leg movement.
Time Frame
Baseline, 12 weeks follow up
Title
Change in muscle function assessed by Lower Extremity Strength test
Description
Standardized strength assessment protocol that includes 4-6 trials with rest periods of the leg extension, leg press, and chest press exercises will be used. Strength in the right and left legs will be tested separately.
Time Frame
Baseline, 12 weeks follow up
Title
Change in Timed Up and Go (TUG) completion time
Description
Subjects are observed and timed while they rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time to complete this task will be recorded.
Time Frame
Baseline, 12 weeks follow up
Title
Change in 30 meter walk velocity
Description
Self-selected and fastest-comfortable floor walking velocity will be determined from 30 meter walks with subjects using the same assistive device and/or orthosis as normally used to "walk across the room at home."
Time Frame
Baseline, 12 weeks follow up
Title
Change in Functional Gait Assessment score
Description
Subjects will be asked to perform various tasks to assess functional gait including stepping onto a small stool, doing a turn, and picking a small object off the floor. Participants will be scored on their ability to perform each task without difficulty. A total score out of a maximum of 30 points will be reported.
Time Frame
Baseline, 12 weeks follow up
Title
Change in 6 min walk distance
Description
Subjects will use the same assistive device typically used and will be instructed to cover as much distance as they can in six minutes over a flat walking surface.
Time Frame
Baseline, 12 weeks follow up
Title
Change in Resting Metabolic Rate (RMR)
Description
RMR will be measured using the ventilated hood technique while subjects lie quietly in bed for 30-45 mins under a clear plastic hood with expired air collected through a one-way valve. RMR will be measured at rest under fasting conditions. It will be reported as a continuous variable of kilocalories/day.
Time Frame
Baseline, 12 weeks follow up
Title
Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
Description
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) is a key transcription coactivator regulating energy metabolism in a tissue-specific manner. PGC-1α level will be measured by enzyme-linked immunosorbent assay in blood sample.
Time Frame
Baseline, 12 weeks follow up
Title
Change in kynurenic acid level
Description
Kynurenic acid is a product of the normal metabolism of amino acid L-tryptophan. It has been shown that kynurenic acid possesses neuroactive activity. Kynurenic acid level will be measured by enzyme-linked immunosorbent assay in blood sample. .
Time Frame
Baseline, 12 weeks follow up
Title
Change in interleukin-6 (IL-6) level
Description
IL-6 is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory marker in skeletal muscle. IL-6 level will be measured by enzyme-linked immunosorbent assay in blood sample.
Time Frame
Baseline, 12 weeks follow up
Title
Change in tumor necrosis factor-α (TNF-α) protein level
Description
tumor necrosis factor-α (TNF-α) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction.TNF-α protein level will be measured by enzyme-linked immunosorbent assay in blood sample.
Time Frame
Baseline, 12 weeks follow up
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
at least 6 months post breast reconstruction (if applicable),
lack of menses for at least one year,
BMI 20-35 kg/m2,
fatigued (subjective reporting ≥3 on a 1-10 scale),
untrained with regard to structured resistance training (no more than 3x/week).
Exclusion Criteria:
plans for surgery (e.g., breast reconstruction) during the study period,
taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
allergic to lidocaine,
orthopedic or chronic pain condition restricting exercise,
Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education),
unable to receive physician medical clearance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Serra, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
We'll reach out to this number within 24 hrs