Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
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.
Behavioral: exercise intervention
Procedure: complementary or alternative medicine procedure
Procedure: fatigue assessment and management
Procedure: physical therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||A RENEW Intervention for Elderly Cancer Survivors|
- Patient perception and pattern of change [ Time Frame: 3 months of training followed by 6 and 12 months of no formal training ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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
|Study Start Date:||March 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Behavioral: exercise intervention
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|