Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A RENEW Intervention for Elderly Cancer Survivors

Conditions
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Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Fatigue, Lung Cancer, Lymphoma, Ovarian Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: exercise intervention
* Procedure: complementary or alternative medicine procedure
* Procedure: fatigue assessment and management
* Procedure: physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise intervention|12 weeks of 3x/week training on a recumbent eccentric stepper|
|Procedure: complementary or alternative medicine procedure|12 weeks of 3x/week training on the eccentron|
|Procedure: fatigue assessment and management|The visual analog scale will be used to assess muscle soreness from the previous exercise session|
|Procedure: physical therapy|12 weeks of 3x/week training on the eccentron|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception and pattern of change | To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status | 3 months of training followed by 6 and 12 months of no formal training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural and function changes | 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 | 3 months of training followed by 6 and 12 months of no formal training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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