Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00335491|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : September 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Breast Cancer Colorectal Cancer Esophageal Cancer Fatigue Lung Cancer Lymphoma Ovarian Cancer Prostate Cancer||Behavioral: exercise intervention Procedure: complementary or alternative medicine procedure Procedure: fatigue assessment and management Procedure: physical therapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A RENEW Intervention for Elderly Cancer Survivors|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
- Behavioral: exercise intervention
12 weeks of 3x/week training on a recumbent eccentric stepperOther Name: Eccentron
- Procedure: complementary or alternative medicine procedure
12 weeks of 3x/week training on the eccentronOther Name: 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
- Patient perception and pattern of change [ Time Frame: 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
- Structural and function changes [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335491
|United States, Utah|
|Huntsman Cancer Institute at University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Paul C. LaStayo, PhD, PT||University of Utah|