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

This study has been completed.
Sponsor:
Collaborator:
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

June 8, 2006
September 28, 2011
March 2006
March 2010   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00335491 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
A RENEW Intervention for Elderly 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Fatigue
  • Lung Cancer
  • Lymphoma
  • Ovarian Cancer
  • Prostate Cancer
  • 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
Not Provided
LaStayo PC, Marcus RL, Dibble LE, Smith SB, Beck SL. Eccentric exercise versus usual-care with older cancer survivors: the impact on muscle and mobility--an exploratory pilot study. BMC Geriatr. 2011 Jan 27;11:5. doi: 10.1186/1471-2318-11-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00335491
14551, R21CA114523, P30CA042014, UUMC-R21CA114523
Yes
Paul LaStayo, University of Utah
University of Utah
National Cancer Institute (NCI)
Principal Investigator: Paul C. LaStayo, PhD, PT University of Utah
University of Utah
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP