Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Fatigue, Lung Cancer, Lymphoma, Ovarian Cancer, Prostate Cancer
Conditions
Keywords
small cell lung cancer, non-small cell lung cancer, colon cancer, prostate cancer, breast cancer, male breast cancer, fatigue, lymphoma, ovarian epithelial cancer, bladder cancer, esophageal cancer
Brief summary
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors. PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
Detailed description
OBJECTIVES: * Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care. * Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility. * Evaluate the patient's adherence to and satisfaction with the RENEW intervention. OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW. * Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Interventions
BEHAVIORALexercise intervention
12 weeks of 3x/week training on a recumbent eccentric stepper
12 weeks of 3x/week training on the eccentron
PROCEDUREfatigue assessment and management
The visual analog scale will be used to assess muscle soreness from the previous exercise session
PROCEDUREphysical therapy
12 weeks of 3x/week training on the eccentron
Sponsors
National Cancer Institute (NCI)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease * At least moderate levels of fatigue and/or weakness * Impaired mobility but ambulatory and medically able to participate in an exercise regimen * No impaired knee flexion, defined as \< 90º PATIENT CHARACTERISTICS: * Folstein Mini-Mental Status Examination score ≥ 23 * No extreme claustrophobia * No diagnosed chronic fatigue syndrome/disorder * No neurological impairments, including the following: * Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease) * Neurological insult (cerebrovascular attack) that manifests in a mobility disorder * No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function * No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica) PRIOR CONCURRENT THERAPY: * More than 6 months since prior regular aerobic or resistance exercise * Regular exercise defined as 2-3 times per week * At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy ) * No concurrent cancer-related treatment other than hormonal therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient perception and pattern of change | 3 months of training followed by 6 and 12 months of no formal training | To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural and function changes | 3 months of training followed by 6 and 12 months of no formal training | To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW |
Countries
United States
Outcome results
None listed