Malignant Neoplasm Clinical Trial
— GET FITOfficial title:
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
Verified date | September 2021 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.
Status | Completed |
Enrollment | 444 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is < stage IV, we will send a letter to her physician to confirm this criterion) - Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion) - Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< 6 months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > 30 mIU/ml and/or serum estradiol < 30 pg/ml) - Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire) Exclusion Criteria: - Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone) - A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible) |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Falls | Prospective assessment of falls will be done by collecting monthly and quarterly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard. | Baseline up to 12 months | |
Secondary | Muscle strength | Measured by 1-repetition maximum (1-RM) for leg press. The maximum amount of weight that can be lifted one time. | Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment | |
Secondary | Postural stability | Measured by Computerized dynamic posturography using the sensory organization test (SOT) and limits of stability (LOS). The SOT generates an equilibrium scores and sensory ratios that range from 0-100, where 100 = perfect stability and 0 = an inability to maintain balance and a fall. The LOS measures the average % of targeted distances reached (end point excursion) and average % of movement in the targeted direction (directional control). | Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment | |
Secondary | Flexibility | Measured by the standardized chair sit-and-reach test for lower body flexibility. Designed for older adults with demonstrated validity and reliability in older adults (test-retest 0.95-0.96). | Baseline, 3 and 6 months during study treatment and 6 months after completion of study | |
Secondary | Physical Function | Measured by the Physical Performance Battery (PPB). The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12. | Baseline, 3 and 6 months during study treatment and 6 months after completion of study | |
Secondary | Injurious falls | Collected during prospective monthly and quarterly reports of falls. A fall is considered ''injurious'' if it results in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or if the participant seeks medical care. | Baseline up to 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02243592 -
Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
|
||
Completed |
NCT03445572 -
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
|
N/A | |
Active, not recruiting |
NCT02860039 -
High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT00026169 -
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
|
Phase 1 | |
Recruiting |
NCT04534075 -
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
|
Phase 3 | |
Active, not recruiting |
NCT01806129 -
Reproductive Health Program in Patients With Cancer
|
N/A | |
Recruiting |
NCT03915717 -
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
|
||
Recruiting |
NCT02280161 -
Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
|
||
Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
Terminated |
NCT00532064 -
Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
|
||
Completed |
NCT04990882 -
FAPI PET/CT Prospective Interobserver Agreement
|
||
Completed |
NCT01896778 -
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
|
N/A | |
Recruiting |
NCT05770102 -
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition
|
Phase 2/Phase 3 | |
Recruiting |
NCT06090266 -
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05886764 -
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
|
N/A | |
Completed |
NCT01506440 -
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
|
||
Completed |
NCT01432431 -
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff
|
N/A | |
Active, not recruiting |
NCT01174264 -
Evaluation of Food Effect on Pharmacokinetics of Vismodegib
|
Phase 1/Phase 2 |