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Clinical Trials/NCT00335491
NCT00335491
Completed
Not Applicable

A RENEW Intervention for Elderly Cancer Survivors

University of Utah1 site in 1 country49 target enrollmentMarch 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
University of Utah
Enrollment
49
Locations
1
Primary Endpoint
Patient perception and pattern of change
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
March 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul LaStayo

PT, PhD

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Structural and function changes(3 months of training followed by 6 and 12 months of no formal training)

Study Sites (1)

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