Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul LaStayo, University of Utah
ClinicalTrials.gov Identifier:
NCT00335491
First received: June 8, 2006
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 49
Study Start Date: March 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise intervention
    12 weeks of 3x/week training on a recumbent eccentric stepper
    Other Name: Eccentron
    Procedure: complementary or alternative medicine procedure
    12 weeks of 3x/week training on the eccentron
    Other 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
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335491

Locations
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul C. LaStayo, PhD, PT University of Utah
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul LaStayo, PT, PhD, University of Utah
ClinicalTrials.gov Identifier: NCT00335491     History of Changes
Obsolete Identifiers: NCT00286715
Other Study ID Numbers: 14551, R21CA114523, P30CA042014, UUMC-R21CA114523
Study First Received: June 8, 2006
Last Updated: September 28, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Utah:
small cell lung cancer
non-small cell lung cancer
colon cancer
prostate cancer
breast cancer
male breast cancer
 fatigue
lymphoma
ovarian epithelial cancer
bladder cancer
esophageal cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Fatigue
Lung Neoplasms
Lymphoma
Ovarian Neoplasms
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
 Urologic Diseases
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 16, 2012