Cancer Clinical Trial
Official title:
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
Verified date | July 2020 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 12, 2020 |
Est. primary completion date | March 9, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer, 2. at least 6 months post breast reconstruction (if applicable), 3. lack of menses for at least one year, 4. BMI 20-35 kg/m2, 5. fatigued (subjective reporting =3 on a 1-10 scale), 6. untrained with regard to structured resistance training (no more than 3x/week). Exclusion Criteria: 1. plans for surgery (e.g., breast reconstruction) during the study period, 2. taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban), 3. allergic to lidocaine, 4. orthopedic or chronic pain condition restricting exercise, 5. 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), 6. unable to receive physician medical clearance. |
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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." | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1a) level | Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1a) is a key transcription coactivator regulating energy metabolism in a tissue-specific manner. PGC-1a level will be measured by enzyme-linked immunosorbent assay in blood sample. | Baseline, 12 weeks follow up | |
Secondary | 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. . | Baseline, 12 weeks follow up | |
Secondary | 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. | Baseline, 12 weeks follow up | |
Secondary | Change in tumor necrosis factor-a (TNF-a) protein level | tumor necrosis factor-a (TNF-a) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction.TNF-a protein level will be measured by enzyme-linked immunosorbent assay in blood sample. | Baseline, 12 weeks follow up |
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