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

Breast Cancer Clinical Trial

Official title:

A RENEW Intervention for Elderly Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335491
• Other study ID #: 14551
• Secondary ID: R21CA114523P30CA
• Status: Completed
• Phase: N/A
• First received: June 8, 2006
• Last updated: September 28, 2011
• Start date: March 2006
• Est. completion date: March 2010

Study information

• Verified date: September 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00286715

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Fatigue
• Lung Cancer
• Lymphoma
• Ovarian Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

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
• fatigue assessment and management
The visual analog scale will be used to assess muscle soreness from the previous exercise session
• physical therapy
12 weeks of 3x/week training on the eccentron

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes