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

Not Applicable

Completed

• Conditions: Bladder Cancer; Breast Cancer; Colorectal Cancer; Esophageal Cancer; Fatigue; Lung Cancer; Lymphoma; Ovarian Cancer; Prostate Cancer

• Registration Number: NCT00335491
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States